Download JNTU Kakinada (Jawaharlal Nehru Technological University, Kakinada) Bachelor of Pharmacy (B.Pharm) B.Pharmacy PCI Syllabus
The B.Pharm course syllabi as prescribed by PCI is adopted and enclosed herwith.
(Dt. 02.03.2020)
JNTUK KAKINADA
Rules & Syllabus for the Bachelor
of Pharmacy (B. Pharm) Course
as approved by
Pharmacy Council of India
New Delhi
----------------------------------------------------------------------------------------------------------------------------- -----------------
[Framed under Regulation 6, 7 & 8 of the Bachelor of
Pharmacy (B. Pharm) course regulations 2014]
CHAPTER- I: REGULATIONS
1. Short Title and Commencement
These regulations shall be called as "The Revised Regulations for the B. Pharm. Degree
Program (CBCS)of the Pharmacy Council of India, New Delhi". They shall come into
effect from the Academic Year 2016-17. The regulations framed are subject to
modifications from time to time by Pharmacy Council of India.
2. Minimum qualification for admission
2.1 First year B. Pharm:
Candidate shall have passed 10+2 examination conducted by the respective
state/central government authorities recognized as equivalent to 10+2 examination
by the Association of Indian Universities (AIU) with English as one of the
subjects and Physics, Chemistry, Mathematics (P.C.M) and or Biology (P.C.B /
P.C.M.B.) as optional subjects individually. Any other qualification approved by
the Pharmacy Council of India as equivalent to any of the above examinations.
2.2. B. Pharm lateral entry (to third semester):
A pass in D. Pharm. course from an institution approved by the Pharmacy Council
of India under section 12 of the Pharmacy Act.
3. Duration of the program
The course of study for B.Pharm shall extend over a period of eight semesters (four
academic years) and six semesters (three academic years) for lateral entry students. The
curricula and syllabi for the program shall be prescribed from time to time by Pharmacy
Council of India, New Delhi.
4. Medium of instruction and examinations
Medium of instruction and examination shall be in English.
5. Working days in each semester
Each semestershall consist of not less than 100 working days. The odd semesters shall be
conducted from the month of June/July to November/December and the even semesters
shall be conducted from December/January to May/June in every calendar year.
6. Attendance and progress
A candidate is required to put in at least 80% attendance in individual courses considering
theory and practical separately. The candidate shall complete the prescribed course
satisfactorily to be eligible to appear for the respective examinations.
2
7. Program/Course credit structure
As per the philosophy of Credit Based Semester System, certain quantum of academic
work viz. theory classes, tutorial hours, practical classes, etc. are measured in terms of
credits. On satisfactory completion of the courses, a candidate earns credits. The amount
of credit associated with a course is dependent upon the number of hours of instruction
per week in that course. Similarly, the credit associated with any of the other academic,
co/extra-curricular activities is dependent upon the quantum of work expected to be put
in for each of these activities per week.
7.1 Credit assignment
7.1.1 Theory and Laboratory courses
Courses are broadly classified as Theory and Practical. Theory courses consist of
lecture (L) and /or tutorial (T) hours, and Practical (P) courses consist of hours
spent in the laboratory. Credits (C) for a course is dependent on the number of
hours of instruction per week in that course, and is obtained by using a multiplier
of one (1) for lecture and tutorial hours, and a multiplier of half (1/2) for practical
(laboratory) hours. Thus, for example, a theory course having three lectures and
one tutorial per week throughout the semester carries a credit of 4. Similarly, a
practical having four laboratory hours per week throughout semester carries a
credit of 2.
7.2 Minimum credit requirements
The minimum credit points required for award of a B. Pharm. degree is 208.
These credits are divided into Theory courses, Tutorials, Practical, Practice
School and Projectover the duration of eight semesters. The credits are distributed
semester-wise as shown in Table IX. Courses generally progress in sequences,
building competencies and their positioning indicates certain academic maturity
on the part of the learners. Learners are expected to follow the semester-wise
schedule of courses given in the syllabus.
The lateral entry students shall get 52 credit points transferred from their D.
Pharm program. Such students shall take up additional remedial courses of
`Communication Skills' (Theory and Practical) and `Computer Applications in
Pharmacy' (Theory and Practical) equivalent to 3 and 4 credit points respectively,
a total of 7 credit points to attain 59 credit points, the maximum of I and II
semesters.
8. Academic work
A regular record of attendance both in Theory and Practical shall be maintained by the
teaching staff of respective courses.
3
9. Course of study
The course of study for B. Pharm shall include Semester Wise Theory & Practical as
given in Table ? I to VIII. The number of hours to be devoted to each theory, tutorial and
practical course in any semester shall not be less than that shown in Table ? I to VIII.
Table-I: Course of study for semester I
No. of
Tuto
Credit
Course code
Name of the course
hours
rial
points
Human Anatomy and Physiology I?
BP101T
3
1
4
Theory
BP102T
Pharmaceutical Analysis I ? Theory
3
1
4
BP103T
Pharmaceutics I ? Theory
3
1
4
BP104T
Pharmaceutical Inorganic Chemistry ?
Theory
3
1
4
BP105T
Communication skills ? Theory *
2
-
2
BP106RBT
Remedial Biology/
2
-
2
BP106RMT
Remedial Mathematics ? Theory*
Human Anatomy and Physiology ?
BP107P
4
-
2
Practical
BP108P
Pharmaceutical Analysis I ? Practical
4
-
2
BP109P
Pharmaceutics I ? Practical
4
-
2
BP110P
Pharmaceutical Inorganic Chemistry ?
Practical
4
-
2
BP111P
Communication skills ? Practical*
2
-
1
BP112RBP
Remedial Biology ? Practical*
2
-
1
Total 32/34$/36#
4
27/29$/30#
#Applicable ONLY for the students who have studied Mathematics / Physics / Chemistry at HSC and
appearing for Remedial Biology (RB)course.
$Applicable ONLY for the students who have studied Physics / Chemistry / Botany / Zoology at HSC and
appearing for Remedial Mathematics (RM)course.
* Non University Examination (NUE)
4
Table-II: Course of study for semester II
Course
No. of
Credit
Name of the course
Tutorial
Code
hours
points
BP201T Human Anatomy and Physiology II ? Theory
3
1
4
BP202T Pharmaceutical Organic Chemistry I ? Theory
3
1
4
BP203T Biochemistry ? Theory
3
1
4
BP204T Pathophysiology ? Theory
3
1
4
BP205T Computer Applications in Pharmacy ? Theory *
3
-
3
BP206T Environmental sciences ? Theory *
3
-
3
BP207P Human Anatomy and Physiology II ?Practical
4
-
2
BP208P Pharmaceutical Organic Chemistry I? Practical
4
-
2
BP209P Biochemistry ? Practical
4
-
2
BP210P Computer Applications in Pharmacy ? Practical*
2
-
1
Total
32
4
29
*Non University Examination (NUE)
Table-III: Course of study for semester III
Course
No. of
Credit
Name of the course
Tutorial
code
hours
points
BP301T Pharmaceutical Organic Chemistry II ? Theory
3
1
4
BP302T Physical Pharmaceutics I ? Theory
3
1
4
BP303T Pharmaceutical Microbiology ? Theory
3
1
4
BP304T Pharmaceutical Engineering ? Theory
3
1
4
BP305P Pharmaceutical Organic Chemistry II ? Practical
4
-
2
BP306P Physical Pharmaceutics I ? Practical
4
-
2
BP307P Pharmaceutical Microbiology ? Practical
4
-
2
BP 308P Pharmaceutical Engineering ?Practical
4
-
2
Total
28
4
24
5
Table-IV: Course of study for semester IV
Course
No. of
Credit
Name of the course
Tutorial
code
hours
points
BP401T Pharmaceutical Organic Chemistry III? Theory
3
1
4
BP402T Medicinal Chemistry I ? Theory
3
1
4
BP403T Physical Pharmaceutics II ? Theory
3
1
4
BP404T Pharmacology I ? Theory
3
1
4
BP405T Pharmacognosy and Phytochemistry I? Theory
3
1
4
BP406P Medicinal Chemistry I ? Practical
4
-
2
BP407P Physical Pharmaceutics II ? Practical
4
2
BP408P Pharmacology I ? Practical
4
-
2
BP409P Pharmacognosy and Phytochemistry I ? Practical
4
-
2
Total
31
5
28
Table-V: Course of study for semester V
Course
No. of
Credit
Name of the course
Tutorial
code
hours
points
BP501T Medicinal Chemistry II ? Theory
3
1
4
BP502T Industrial PharmacyI? Theory
3
1
4
BP503T Pharmacology II ? Theory
3
1
4
BP504T Pharmacognosy and Phytochemistry II? Theory
3
1
4
BP505T Pharmaceutical Jurisprudence ? Theory
3
1
4
BP506P Industrial PharmacyI ? Practical
4
-
2
BP507P Pharmacology II ? Practical
4
-
2
BP508P Pharmacognosy and Phytochemistry II ?
4
-
2
Practical
Total
27
5
26
6
Table-VI: Course of study for semester VI
Course
No. of
Credit
Name of the course
Tutorial
code
hours
points
BP601T Medicinal Chemistry III ? Theory
3
1
4
BP602T Pharmacology III ? Theory
3
1
4
BP603T Herbal Drug Technology ? Theory
3
1
4
BP604T Biopharmaceutics and Pharmacokinetics ?
3
1
4
Theory
BP605T Pharmaceutical Biotechnology ? Theory
3
1
4
BP606T Quality Assurance ?Theory
3
1
4
BP607P Medicinal chemistry III ? Practical
4
-
2
BP608P Pharmacology III ? Practical
4
-
2
BP609P Herbal Drug Technology ? Practical
4
-
2
Total
30
6
30
Table-VII: Course of study for semester VII
Course
No. of
Credit
Name of the course
Tutorial
code
hours
points
BP701T Instrumental Methods of Analysis ? Theory
3
1
4
BP702T Industrial PharmacyII ? Theory
3
1
4
BP703T Pharmacy Practice ? Theory
3
1
4
BP704T Novel Drug Delivery System ? Theory
3
1
4
BP705P Instrumental Methods of Analysis ? Practical
4
-
2
BP706PS Practice School*
12
-
6
Total
28
5
24
* Non University Examination (NUE)
7
Table-VIII: Course of study for semester VIII
Course
No. of
Credit
Name of the course
Tutorial
code
hours
points
BP801T
Biostatistics and Research Methodology
3
1
4
BP802T
Social and Preventive Pharmacy
3
1
4
BP803ET Pharma Marketing Management
BP804ET Pharmaceutical Regulatory Science
BP805ET Pharmacovigilance
BP806ET Quality Control and Standardization of
3 + 3 =
4 + 4 =
Herbals
1 + 1 = 2
6
8
BP807ET Computer Aided Drug Design
BP808ET Cell and Molecular Biology
BP809ET Cosmetic Science
BP810ET Experimental Pharmacology
BP811ET Advanced Instrumentation Techniques
BP812ET Dietary Supplements and Nutraceuticals
BP813PW Project Work
12
-
6
Total
24
4
22
Table-IX: Semester wise credits distribution
Semester
Credit Points
I
27/29$/30#
II
29
III
26
IV
28
V
26
VI
26
VII
24
VIII
22
Extracurricular/ Co curricular activities
01*
Total credit points for the program
209/211$/212#
* The credit points assigned for extracurricular and or co-curricular activities shall be given by the
Principals of the colleges and the same shall be submitted to the University. The criteria to acquire this
credit point shall be defined by the colleges from time to time.
$Applicable ONLY for the students studied Physics / Chemistry / Botany / Zoology at HSC and appearing
for Remedial Mathematics course.
#Applicable ONLY for the students studied Mathematics / Physics / Chemistry at HSC and appearing for
Remedial Biology course.
8
10. Program Committee
1. The B. Pharm. program shall have a Program Committee constituted by the Head
of the institution in consultation with all the Heads of the departments.
2. The composition of the Program Committee shall be as follows:
A senior teacher shall be the Chairperson; One Teacher from each department
handling B.Pharm courses; and four student representatives of the program (one
from each academic year), nominated by the Head of the institution.
3. Duties of the Program Committee:
i. Periodically reviewing the progress of the classes.
ii. Discussing the problems concerning curriculum, syllabus and the conduct of
classes.
iii. Discussing with the course teachers on the nature and scope of assessment for
the course and the same shall be announced to the students at the beginning of
respective semesters.
iv. Communicating its recommendation to the Head of the institution on academic
matters.
v. The Program Committee shall meet at least thrice in a semester preferably at
the end of each Sessionalexam (Internal Assessment) and before the end
semester exam.
11. Examinations/Assessments
The scheme for internal assessment and end semester examinations is given in Table ? X.
11.1 End semester examinations
The End Semester Examinations for each theory and practical coursethrough semesters I
to VIII shall beconducted by the university except for the subjects with asterix symbol (*)
in table I and II for which examinations shall be conducted by the subject experts at
college level and the marks/grades shall be submitted to the university.
9
Tables-X: Schemes for internal assessments and end semester examinations semester wise
Semester I
Internal Assessment
End Semester Exams
Course
Total
Name of the course
code
Continuous
Sessional Exams
Marks
Mode
Total
Marks
Duration
Marks
Duration
BP101T
Human Anatomy and
10
15
1 Hr
25
75
3 Hrs
100
Physiology I? Theory
BP102T
Pharmaceutical Analysis I ?
Theory
10
15
1 Hr
25
75
3 Hrs
100
BP103T
Pharmaceutics I ? Theory
10
15
1 Hr
25
75
3 Hrs
100
BP104T
Pharmaceutical Inorganic
10
15
1 Hr
25
75
3 Hrs
100
Chemistry ? Theory
BP105T
Communication skills ?
Theory *
5
10
1 Hr
15
35
1.5 Hrs
50
BP106RBT Remedial Biology/
5
10
1 Hr
15
35
1.5 Hrs
50
BP106RMT Mathematics ? Theory*
BP107P
Human Anatomy and
5
10
4 Hrs
15
35
4 Hrs
50
Physiology ? Practical
BP108P
Pharmaceutical Analysis I ?
Practical
5
10
4 Hrs
15
35
4 Hrs
50
BP109P
Pharmaceutics I ? Practical
5
10
4 Hrs
15
35
4 Hrs
50
BP110P
Pharmaceutical Inorganic
5
10
4 Hrs
15
35
4 Hrs
50
Chemistry ? Practical
BP111P
Communication skills ?
Practical*
5
5
2 Hrs
10
15
2 Hrs
25
BP112RBP Remedial Biology ?
Practical*
5
5
2 Hrs
10
15
2 Hrs
25
Total
70/75$/80#
115/125$/130#
23/24$/26#
185/200$/210#
490/525$/
31.5/33$/
675/725$/
Hrs
540#
35# Hrs
750#
#Applicable ONLY for the students studied Mathematics / Physics / Chemistry at HSC and appearing for Remedial Biology (RB)course.
$Applicable ONLY for the students studied Physics / Chemistry / Botany / Zoology at HSC and appearing for Remedial Mathematics (RM)course.
* Non University Examination(NUE)
10
Semester II
Internal Assessment
End Semester Exams
Course
Total
Name of the course
code
Continuous
Sessional Exams
Total
Marks
Duration
Marks
Mode
Marks
Duration
Human Anatomy and Physiology
BP201T
10
15
1 Hr
25
75
3 Hrs
100
II ? Theory
Pharmaceutical Organic
BP202T
10
15
1 Hr
25
75
3 Hrs
100
Chemistry I ? Theory
BP203T Biochemistry ? Theory
10
15
1 Hr
25
75
3 Hrs
100
BP204T Pathophysiology ? Theory
10
15
1 Hr
25
75
3 Hrs
100
Computer Applications in
BP205T
10
15
1 Hr
25
50
2 Hrs
75
Pharmacy ? Theory*
BP206T Environmental sciences ? Theory*
10
15
1 Hr
25
50
2 Hrs
75
BP207P Human Anatomy and Physiology
5
10
4 Hrs
15
35
4 Hrs
50
II ?Practical
Pharmaceutical Organic
BP208P
5
10
4 Hrs
15
35
4 Hrs
50
Chemistry I? Practical
BP209P Biochemistry ? Practical
5
10
4 Hrs
15
35
4 Hrs
50
BP210P Computer Applications in
5
5
2 Hrs
10
15
2 Hrs
25
Pharmacy ? Practical*
Total
80
125
20 Hrs
205
520
30 Hrs
725
* The subject experts at college level shall conduct examinations
11
Semester III
Internal Assessment
End Semester Exams
Course
Total
Name of the course
code
Continuous
Sessional Exams
Total
Marks
Duration
Marks
Mode
Marks
Duration
Pharmaceutical Organic
BP301T
10
15
1 Hr
25
75
3 Hrs
100
Chemistry II ? Theory
BP302T PhysicalPharmaceuticsI ?Theory
10
15
1 Hr
25
75
3 Hrs
100
BP303T Pharmaceutical Microbiology ?
10
15
1 Hr
25
75
3 Hrs
100
Theory
BP304T Pharmaceutical Engineering ?
10
15
1 Hr
25
75
3 Hrs
100
Theory
BP305P Pharmaceutical Organic
5
10
4 Hr
15
35
4 Hrs
50
Chemistry II ? Practical
BP306P Physical Pharmaceutics I ?
5
10
4 Hr
15
35
4 Hrs
50
Practical
BP307P Pharmaceutical Microbiology ?
5
10
4 Hr
15
35
4 Hrs
50
Practical
BP308P Pharmaceutical Engineering ?
5
10
4 Hr
15
35
4 Hrs
50
Practical
Total
60
100
20
160
440
28Hrs
600
12
Semester IV
Internal Assessment
End Semester Exams
Course
Total
Name of the course
code
Continuous
Sessional Exams
Total
Marks
Duration
Marks
Mode
Marks
Duration
BP401T Pharmaceutical Organic
10
15
1 Hr
25
75
3 Hrs
100
Chemistry III? Theory
BP402T Medicinal Chemistry I ? Theory
10
15
1 Hr
25
75
3 Hrs
100
BP403T Physical Pharmaceutics II ?
10
15
1 Hr
25
75
3 Hrs
100
Theory
BP404T Pharmacology I ? Theory
10
15
1 Hr
25
75
3 Hrs
100
BP405T Pharmacognosy I ? Theory
10
15
1 Hr
25
75
3 Hrs
100
BP406P Medicinal Chemistry I ? Practical
5
10
4 Hr
15
35
4 Hrs
50
BP407P Physical Pharmaceutics II ?
5
10
4 Hrs
15
35
4 Hrs
50
Practical
BP408P Pharmacology I ? Practical
5
10
4 Hrs
15
35
4 Hrs
50
BP409P Pharmacognosy I ? Practical
5
10
4 Hrs
15
35
4 Hrs
50
Total
70
115
21 Hrs
185
515
31 Hrs
700
13
Semester V
Internal Assessment
End Semester Exams
Course
Total
Name of the course
code
Continuous
Sessional Exams
Total
Marks
Duration
Marks
Mode
Marks
Duration
BP501T Medicinal Chemistry II ? Theory
10
15
1 Hr
25
75
3 Hrs
100
BP502T Industrial PharmacyI? Theory
10
15
1 Hr
25
75
3 Hrs
100
BP503T Pharmacology II ? Theory
10
15
1 Hr
25
75
3 Hrs
100
BP504T Pharmacognosy II ? Theory
10
15
1 Hr
25
75
3 Hrs
100
Pharmaceutical Jurisprudence ?
BP505T
10
15
1 Hr
25
75
3 Hrs
100
Theory
BP506P Industrial PharmacyI? Practical
5
10
4 Hr
15
35
4 Hrs
50
BP507P Pharmacology II ? Practical
5
10
4 Hr
15
35
4 Hrs
50
BP508P Pharmacognosy II ? Practical
5
10
4 Hr
15
35
4 Hrs
50
Total
65
105
17 Hr
170
480
27 Hrs
650
14
Semester VI
Internal Assessment
End Semester Exams
Course
Total
Name of the course
code
Continuous
Sessional Exams
Total
Marks
Duration
Marks
Mode
Marks
Duration
BP601T Medicinal Chemistry III ? Theory
10
15
1 Hr
25
75
3 Hrs
100
BP602T Pharmacology III ? Theory
10
15
1 Hr
25
75
3 Hrs
100
BP603T Herbal Drug Technology ?
10
15
1 Hr
25
75
3 Hrs
100
Theory
BP604T Biopharmaceutics and
10
15
1 Hr
25
75
3 Hrs
100
Pharmacokinetics ? Theory
BP605T Pharmaceutical Biotechnology?
10
15
1 Hr
25
75
3 Hrs
100
Theory
BP606T Quality Assurance? Theory
10
15
1 Hr
25
75
3 Hrs
100
BP607P Medicinal chemistry III ?
5
10
4 Hrs
15
35
4 Hrs
50
Practical
BP608P Pharmacology III ? Practical
5
10
4 Hrs
15
35
4 Hrs
50
BP609P Herbal Drug Technology ?
5
10
4 Hrs
15
35
4 Hrs
50
Practical
Total
75
120
18 Hrs
195
555
30 Hrs
750
15
Semester VII
Internal Assessment
End Semester
Course
Exams
Total
Name of the course
code
Continuous
Sessional Exams
Marks
Total
Marks
Duration
Mode
Marks
Duration
Instrumental Methods of Analysis
BP701T
10
15
1 Hr
25
75
3 Hrs
100
? Theory
BP702T Industrial Pharmacy ? Theory
10
15
1 Hr
25
75
3 Hrs
100
BP703T Pharmacy Practice ? Theory
10
15
1 Hr
25
75
3 Hrs
100
BP704T Novel Drug Delivery System ?
10
15
1 Hr
25
75
3 Hrs
100
Theory
Instrumental Methods of Analysis
BP705 P
5
10
4 Hrs
15
35
4 Hrs
50
? Practical
BP706 PS Practice School*
25
-
-
25
125
5 Hrs
150
Total
70
70
8Hrs
140
460
21 Hrs
600
* The subject experts at college level shall conduct examinations
16
Semester VIII
Internal Assessment
End Semester Exams
Course
Total
Name of the course
code
Continuous
Sessional Exams
Total
Marks
Duration
Marks
Mode
Marks
Duration
BP801T
Biostatistics and Research
10
15
1 Hr
25
75
3 Hrs
100
Methodology ? Theory
Social and Preventive Pharmacy
BP802T
10
15
1 Hr
25
75
3 Hrs
100
? Theory
BP803ET Pharmaceutical Marketing ?
Theory
Pharmaceutical Regulatory
BP804ET Science ? Theory
BP805ET Pharmacovigilance ? Theory
Quality Control and
BP806ET Standardization of Herbals ?
Theory
10 + 10
15 + 15 =
1 + 1 =
25 + 25 =
75 + 75
3 + 3 = 6
100 +
= 20
30
2 Hrs
50
= 150
Hrs
100 =
BP807ET Computer Aided Drug Design ?
200
Theory
BP808ET Cell and Molecular Biology ?
Theory
BP809ET Cosmetic Science ? Theory
BP810ET Experimental Pharmacology ?
Theory
BP811ET Advanced Instrumentation
Techniques ? Theory
BP812PW Project Work
-
-
-
-
150
4 Hrs
150
Total
40
60
4 Hrs
100
450
16 Hrs
550
17
11.2 Internal assessment: Continuous mode
The marks allocated for Continuous mode of Internal Assessment shall be awarded
as per the scheme given below.
Table-XI: Scheme for awarding internal assessment: Continuous mode
Theory
Criteria
Maximum
Marks
Attendance (Refer Table ? XII)
4
2
Academic activities (Average of any 3 activities e.g. quiz, assignment,
3
1.5
open book test, field work, group discussion and seminar)
Student ? Teacher interaction
3
1.5
Total
10
5
Practical
Attendance (Refer Table ? XII)
2
Based on Practical Records, Regular viva voce, etc.
3
Total
5
Table- XII: Guidelines for the allotment of marks for attendance
Percentage of Attendance
Theory
Practical
95 ? 100
4
2
90 ? 94
3
1.5
85 ? 89
2
1
80 ? 84
1
0.5
Less than 80
0
0
11.2.1 Sessional Exams
Two Sessional exams shall be conducted for each theory / practical course as per the
schedule fixed by the college(s). The scheme of question paper for theory and practical
Sessional examinations is given below. The average marks of two Sessional exams shall
be computed for internal assessment as per the requirements given in tables ? X.
Sessional exam shall be conducted for 30 marks for theory and shall be computed
for 15 marks. Similarly Sessional exam for practical shall be conducted for 40 marks and
shall be computed for 10 marks.
Question paper pattern for theory Sessional examinations
For subjects having University examination
I. Multiple Choice Questions (MCQs)
=
10 x 1 = 10
OR
OR
Objective Type Questions (5 x 2)
=
05 x 2 = 10
(Answer all the questions)
I. Long Answers (Answer 1 out of 2)
=
1 x 10 = 10
II. Short Answers (Answer 2 out of 3)
=
2 x 5 = 10
Total =
30 marks
18
For subjects having Non University Examination
I. Long Answers (Answer 1 out of 2)
=
1 x 10 = 10
II. Short Answers (Answer 4 out of 6)
=
4 x 5 = 20
Total =
30 marks
------------------
Question paper pattern for practical sessional examinations
I. Synopsis
=
10
II. Experiments
=
25
III. Viva voce
=
05
Total =
40 marks
------------------
12. Promotion and award of grades
A student shall be declared PASSand eligible for getting gradein a course of
B.Pharm.program if he/she secures at least 50% marks in that particular course including
internal assessment.For example, to be declared as PASS and to get grade, the student has
to secure a minimum of 50 marks for the total of 100 including continuous mode of
assessment and end semester theory examination and has to secure a minimum of 25
marks for the total 50 including internal assessment and end semester practical
examination.
13. Carry forward of marks
In case a studentfails to secure the minimum 50% in any Theory or Practical course as
specified in 12,then he/she shall reappear for the end semester examinationof that course.
However his/her marks of the Internal Assessmentshallbe carried overand he/she shall be
entitled for grade obtained by him/her on passing.
14. Improvement of internal assessment
A studentshall have the opportunity to improvehis/her performance only oncein the
Sessional exam component of the internal assessment. The re-conduct of the Sessional
exam shall be completed before the commencement of next end semester theory
examinations.
15. Re-examination of end semester examinations
Reexamination ofend semester examinationshall be conducted as per the schedule given
in table XIII. The exact dates of examinations shall be notified from time to time.
19
Table-XIII: Tentative schedule of end semester examinations
Semester
For Regular Candidates
For Failed Candidates
I, III, V and VII
November / December
May / June
II, IV, VI and VIII
May / June
November / December
Question paper pattern for end semester theory examinations
For 75 marks paper
I. Multiple Choice Questions(MCQs)
=
20 x 1 = 20
OR
OR
Objective Type Questions (10 x 2)
=
10 x 2 = 20
(Answer all the questions)
II. Long Answers (Answer 2 out of 3)
=
2 x 10 = 20
III. Short Answers (Answer 7 out of 9)
=
7 x 5 = 35
Total =
75 marks
------------------
For 50 m
arks paper
I. Long Answers (Answer 2 out of 3)
=
2 x 10 = 20
II. Short Answers (Answer 6 out of 8)
=
6 x 5 = 30
Total =
50 marks
------------------
For 35 marks paper
I. Long Answers (Answer 1 out of 2)
=
1 x 10 =10
II. Short Answers (Answer 5 out of 7)
=
5 x 5 = 25
Total =
35 marks
------------------
Question paper pattern for end semester practical examinations
I. Synopsis
=
5
II. Experiments
=
25
III. Viva voce
=
5
Total =
35 marks
------------------
20
16. Academic Progression:
No student shall be admitted to any examination unless he/she fulfills the norms given in
6. Academic progression rules are applicable as follows:
A student shall be eligible to carry forward all the courses of I, II and III semesters till the
IV semester examinations. However, he/she shall not be eligible to attend the courses of V
semester until all the courses of I and II semesters are successfully completed.
A student shall be eligible to carry forward all the courses of III, IV and V semesters till
the VI semester examinations. However, he/she shall not be eligible to attend the courses
of VII semester until all the courses of I, II, III and IV semesters are successfully
completed.
A student shall be eligible to carry forward all the courses of V, VI and VII semesters till
the VIII semester examinations. However, he/she shall not be eligible to get the course
completion certificate until all the courses of I, II, III, IV, V and VI semesters are
successfully completed.
A student shall be eligible to get his/her CGPA upon successful completion of the courses
of I to VIII semesters within the stipulated time period as per the norms specified in 26.
A lateral entry student shall be eligible to carry forward all the courses of III, IV and V
semesters till the VI semester examinations. However, he/she shall not be eligible to
attend the courses of VII semester until all the courses of III and IV semesters are
successfully completed.
A lateral entry student shall be eligible to carry forward all the courses of V, VI and VII
semesters till the VIII semester examinations. However, he/she shall not be eligible to get
the course completion certificate until all the courses of III, IV, V and VI semesters are
successfully completed.
A lateral entry student shall be eligible to get his/her CGPA upon successful completion
of the courses of III to VIII semesters within the stipulated time period as per the norms
specified in 26.
Any student who hasgiven more than 4 chances for successful completion of I / III
semester courses and more than 3 chances for successful completion of II / IV semester
courses shall be permitted to attend V / VII semester classes ONLY during the
subsequent academic year as the case may be. In simpler terms there shall NOT be any
ODD BATCH for any semester.
21
Note: Grade AB should be considered as failed and treated as one head for deciding
academic progression. Such rules are also applicable for those students who fail to register
for examination(s) of any course in anysemester.
17. Grading of performances
17.1 Letter grades and grade points allocations:
Based on the performances, each student shall be awarded a final letter grade at the end
of the semester for each course.The letter grades and their corresponding grade points are
given in Table ? XII.
Table ? XII: Letter grades and grade points equivalent to
Percentage of marks and performances
Percentage of
Letter Grade
Grade Point
Performance
Marks Obtained
90.00 ? 100
O
10
Outstanding
80.00 ? 89.99
A
9
Excellent
70.00 ? 79.99
B
8
Good
60.00 ? 69.99
C
7
Fair
50.00 ? 59.99
D
6
Average
Less than 50
F
0
Fail
Absent
AB
0
Fail
A learner who remains absent for any end semester examination shall be assigned a letter
grade of ABand a corresponding grade point of zero. He/she should reappear for the said
evaluation/examination in due course.
18. The Semester grade point average (SGPA)
The performance of a student in a semester is indicated by a number called `Semester
Grade Point Average' (SGPA). The SGPA is the weighted average of the grade points
obtainedin all the courses by the student during the semester. For example, if a student
takes five courses(Theory/Practical) in a semester with credits C1, C2, C3, C4 and C5
and the student's grade pointsin these courses are G1, G2, G3, G4 and G5, respectively,
and then students' SGPA is equal to:
C1G1 + C2G2 + C3G3 + C4G4+ C5G5
SGPA =
--------------------------------------------------
C1 + C2 + C3 + C4+ C5
The SGPA is calculated to two decimal points.It should be noted that, the SGPA for any
semester shall take into consideration the F and ABSgrade awarded in that semester. For
example if a learner has a F or ABS grade in course 4, theSGPA shall then be computed
as:
22
C1G1 + C2G2 + C3G3 + C4* ZERO + C5G5
SGPA =
------------------------------------------------------
C1 + C2 + C3 + C4+ C5
19. Cumulative Grade Point Average (CGPA)
The CGPA is calculated with the SGPA of all the VIII semesters to two decimal points
and is indicated in final grade report card/final transcript showing the grades of all VIII
semesters and their courses. The CGPA shall reflect the failed statusin case of F
grade(s),till the course(s) is/are passed. When the course(s)is/are passedby obtaining a
pass grade on subsequent examination(s) theCGPA shall only reflect the new grade and
not the fail grades earned earlier.The CGPA is calculated as:
C1S1 + C2S2 + C3S3 + C4S4+ C5S5+ C6S6+ C7S7+ C8S8
CGPA =
-------------------------------------------------------------------------
C1 + C2 + C3 + C4+ C5+ C6+ C7+ C8
where C1, C2, C3,.... is the total number of credits for semester I,II,III,.... and S1,S2, S3,....is
the SGPA of semester I,II,III,.... .
20. Declaration of class
The class shall be awarded on the basis of CGPA as follows:
First Class with Distinction = CGPA of. 7.50 and above
First Class
= CGPA of 6.00 to 7.49
Second Class
= CGPA of 5.00 to 5.99
21. Project work
All the students shall undertake a projectunder the supervision of a teacher and submit a
report. The area of the project shall directly relate any one of the elective subject opted by
the student in semester VIII. The project shall be carried out in group not exceeding 5 in
number. The project report shall be submitted in triplicate (typed & bound copy not less
than 25 pages).
The internal and external examiner appointed by the University shall evaluate the project
at the time of the Practical examinations of other semester(s). Students shall be evaluated
in groups for four hours (i.e., about half an hour for a group of five students). The
projects shall be evaluated as per the criteria given below.
23
Evaluation of Dissertation Book:
Objective(s) of the work done
15 Marks
Methodology adopted
20 Marks
Results and Discussions
20 Marks
Conclusions and Outcomes
20 Marks
Total
75 Marks
Evaluation of Presentation:
Presentation of work
25 Marks
Communication skills
20 Marks
Question and answer skills
30 Marks
Total
75 Marks
Explanation: The 75 marks assigned to the dissertation book shall be same for all the
students in a group. However, the 75 marks assigned for presentation shall be awarded
based on the performance of individual students in the given criteria.
22. Industrial training (Desirable)
Every candidate shall be required to work for at least 150 hours spread over four weeks in
a Pharmaceutical Industry/Hospital. It includes Production unit, Quality Control
department, Quality Assurance department, Analytical laboratory, Chemical
manufacturing unit, Pharmaceutical R&D, Hospital (Clinical Pharmacy), Clinical
Research Organization, Community Pharmacy, etc. After the Semester ? VI and before the
commencement of Semester ? VII, and shall submit satisfactory report of such work and
certificate duly signed by the authority of training organization to the head of the institute.
23. Practice School
In the VII semester, every candidate shall undergo practice school for a period of 150
hours evenly distributed throughout the semester. The student shall opt any one of the
domains for practice school declared by the program committee from time to time.
At the end of the practice school, every student shall submit a printed report (in triplicate)
on the practice school he/she attended (not more than 25 pages). Along with the exams of
semester VII, the report submitted by the student, knowledge and skills acquired by the
student through practice school shall be evaluated by the subject experts at college
leveland grade point shall be awarded.
24
24. Award of Ranks
Ranks and Medals shall be awarded on the basis of final CGPA. However, candidates
who fail in one or more courses during the B.Pharm program shall not be eligible for
award of ranks.Moreover, the candidates should have completed the B. Pharm program in
minimum prescribed number of years, (four years) for the award of Ranks.
25. Award of degree
Candidates who fulfill the requirements mentioned above shall be eligible for award of
degree during the ensuing convocation.
26. Duration for completion of the program of study
The duration for the completion of the program shall be fixed as double the actual
duration of the program and the students have to pass within the said period, otherwise
they have to get fresh Registration.
27. Re-admission after break of study
Candidate who seeks re-admission to the program after break of study has to get the
approval from the university by paying a condonation fee.
No condonation is allowed for the candidate who has more than 2 years of break up
period and he/she has to rejoin the program by paying the required fees.
25
CHAPTER - II: SYLLABUS
26
Semester I
27
BP101T. HUMAN ANATOMY AND PHYSIOLOGY-I (Theory)
45 Hours
Scope: This subject is designed to impart fundamental knowledge on the structure and
functions of the various systems of the human body. It also helps in understanding both
homeostatic mechanisms. The subject provides the basic knowledge required to
understand the various disciplines of pharmacy.
Objectives: Upon completion of this course the student should be able to
1. Explain the gross morphology, structure and functions of various organs of the human
body.
2. Describe the various homeostatic mechanisms and their imbalances.
3. Identify the various tissues and organs of different systems of human body.
4. Perform the various experiments related to special senses and nervous system.
5. Appreciate coordinated working pattern of different organs of each system
Course Content:
Unit I
10 hours
? Introduction to human body
Definition and scope of anatomy and physiology, levels of structural
organization and body systems, basic life processes, homeostasis, basic
anatomical terminology.
? Cellular level of organization
Structure and functions of cell, transport across cell membrane, cell
division, cell junctions. General principles of cell communication,
intracellular signaling pathway activation by extracellular signal
molecule, Forms of intracellular signaling: a) Contact-dependent b)
Paracrine c) Synaptic d) Endocrine
? Tissue level of organization
Classification of tissues, structure, location and functions of epithelial,
muscular and nervous and connective tissues.
Unit II
10 hours
? Integumentary system
Structure and functions of skin
? Skeletal system
Divisions of skeletal system, types of bone, salient features and functions
of bones of axial and appendicular skeletal system
Organization of skeletal muscle, physiology of muscle contraction,
neuromuscular junction
28
? Joints
Structural and functional classification, types of joints movements and its
articulation
Unit III
10 hours
? Body fluids and blood
? Body fluids, composition and functions of blood, hemopoeisis, formation of
hemoglobin, anemia, mechanisms of coagulation, blood grouping, Rh factors,
transfusion, its significance and disorders of blood, Reticulo endothelial system.
? Lymphatic system
Lymphatic organs and tissues, lymphatic vessels, lymph circulation and functions of
lymphatic system
Unit IV
08 hours
Peripheral nervous system:
Classification of peripheral nervous system: Structure and functions of
sympathetic and parasympathetic nervous system.
Origin and functions of spinal and cranial nerves.
? Special senses
Structure and functions of eye, ear, nose and tongue and their disorders.
Unit V
07 hours
? Cardiovascular system
Heart ? anatomy of heart, blood circulation, blood vessels, structure and functions of
artery, vein and capillaries, elements of conduction system of heart and heart beat, its
regulation by autonomic nervous system, cardiac output, cardiac cycle. Regulation of
blood pressure, pulse, electrocardiogram and disorders of heart.
29
BP107P. HUMAN ANATOMY AND PHYSIOLOGY (Practical)
4 Hours/week
Practical physiology is complimentary to the theoretical discussions in physiology.
Practicals allow the verification of physiological processes discussed in theory
classes through experiments on living tissue, intact animals or normal human beings.
This is helpful for developing an insight on the subject.
1. Study of compound microscope.
2. Microscopic study of epithelial and connective tissue
3. Microscopic study of muscular and nervous tissue
4. Identification of axial bones
5. Identification of appendicular bones
6. Introduction to hemocytometry.
7. Enumeration of white blood cell (WBC) count
8. Enumeration of total red blood corpuscles (RBC) count
9. Determination of bleeding time
10. Determination of clotting time
11. Estimation of hemoglobin content
12. Determination of blood group.
13. Determination of erythrocyte sedimentation rate (ESR).
14. Determination of heart rate and pulse rate.
15. Recording of blood pressure.
Recommended Books (Latest Editions)
1. Essentials of Medical Physiology by K. Sembulingam and P. Sembulingam. Jaypee
brothers medical publishers, New Delhi.
2. Anatomy and Physiology in Health and Illness by Kathleen J.W. Wilson, Churchill
Livingstone, New York
3. Physiological basis of Medical Practice-Best and Tailor. Williams & Wilkins
Co,Riverview,MI USA
4. Text book of Medical Physiology- Arthur C,Guyton andJohn.E. Hall. Miamisburg,
OH, U.S.A.
5. Principles of Anatomy and Physiology by Tortora Grabowski. Palmetto, GA, U.S.A.
30
6. Textbook of Human Histology by Inderbir Singh, Jaypee brother's medical
publishers, New Delhi.
7. Textbook of Practical Physiology by C.L. Ghai, Jaypee brother's medical publishers,
New Delhi.
8. Practical workbook of Human Physiology by K. Srinageswari and Rajeev Sharma,
Jaypee brother's medical publishers, New Delhi.
Reference Books (Latest Editions)
1. Physiological basis of Medical Practice-Best and Tailor. Williams &
Wilkins Co, Riverview, MI USA
2. Text book of Medical Physiology- Arthur C, Guyton and John. E. Hall. Miamisburg,
OH, U.S.A.
3. Human Physiology (vol 1 and 2) by Dr. C.C. Chatterrje ,Academic Publishers Kolkata
31
BP102T. PHARMACEUTICAL ANALYSIS (Theory)
45 Hours
Scope: This course deals with the fundamentals of analytical chemistry and
principles of electrochemical analysis of drugs
Objectives: Upon completion of the course student shall be able to
? understand the principles of volumetric and electro chemical analysis
? carryout various volumetric and electrochemical titrations
? develop analytical skills
Course Content:
UNIT-I
10 Hours
(a) Pharmaceutical analysis- Definition and scope
i) Different techniques of analysis
ii) Methods of expressing concentration
iii) Primary and secondary standards.
iv) Preparation and standardization of various molar and normal solutions- Oxalic
acid, sodium hydroxide, hydrochloric acid, sodium thiosulphate, sulphuric acid,
potassium permanganate and ceric ammonium sulphate
(b) Errors: Sources of errors, types of errors, methods of minimizing errors, accuracy,
precision and significant figures
(c) Pharmacopoeia, Sources of impurities in medicinal agents, limit tests.
UNIT-II
10 Hours
? Acid base titration: Theories of acid base indicators, classification of acid base
titrations and theory involved in titrations of strong, weak, and very weak acids
and bases, neutralization curves
? Non aqueous titration: Solvents, acidimetry and alkalimetry titration and
estimation of Sodium benzoate and Ephedrine HCl.
? Determination of moisture content by Karl fisher titration.
UNIT-III
10 Hours
? Precipitation titrations: Mohr's method, Volhard's, Modified Volhard's, Fajans
method, estimation of sodium chloride.
? Complexometric titration: Classification, metal ion indicators, masking and
demasking reagents, estimation of Magnesium sulphate, and calcium gluconate.
? Gravimetry: Principle and steps involved in gravimetric analysis. Purity of the
precipitate: co-precipitation and post precipitation, Estimation of barium sulphate.
? Basic Principles, methods and application of diazotisation titration.
32
UNIT-IV
08 Hours
Redox titrations
(a) Concepts of oxidation and reduction
(b) Types of redox titrations (Principles and applications)
Cerimetry, Iodimetry, Iodometry, Bromatometry, Dichrometry, Titration with potassium
iodate
UNIT-V
07 Hours
Electrochemical methods of analysis
? Conductometry- Introduction, Conductivity cell, Conductometric titrations,
applications.
? Potentiometry - Electrochemical cell, construction and working of reference
(Standard hydrogen, silver chloride electrode and calomel electrode) and
indicator electrodes (metal electrodes and glass electrode), methods to determine
end point of potentiometric titration and applications.
? Polarography - Principle, Ilkovic equation, construction and working of
dropping mercury electrode and rotating platinum electrode, applications
33
BP108P. PHARMACEUTICAL ANALYSIS (Practical)
4 Hours / Week
I
Limit Test of the following
(1) Chloride
(2) Sulphate
(3) Iron
(4) Arsenic
II
Preparation and standardization of
(1) Sodium hydroxide
(2) Sulphuric acid
(3) Sodium thiosulfate
(4) Potassium permanganate
(5) Ceric ammonium sulphate
III
Assay of the following compounds along with Standardization of Titrant
(1) Ammonium chloride by acid base titration
(2) Ferrous sulphate by Cerimetry
(3) Copper sulphate by Iodometry
(4) Calcium gluconate by complexometry
(5) Hydrogen peroxide by Permanganometry
(6) Sodium benzoate by non-aqueous titration
(7) Sodium Chloride by precipitation titration
(8) Zinc oxide by back titration
IV
Determination of Normality by electro-analytical methods
(1) Conductometric titration of strong acid against strong base
(2) Conductometric titration of strong acid and weak acid against strong base
(3) Potentiometric titration of strong acid against strong base
Recommended Books: (Latest Editions)
1. A.H. Beckett & J.B. Stenlake's, Practical Pharmaceutical Chemistry Vol I & II, Stahlone
Press of University of London
2. A.I. Vogel, Text Book of Quantitative Inorganic analysis
3. P. Gundu Rao, Inorganic Pharmaceutical Chemistry
4. Bentley and Driver's Textbook of Pharmaceutical Chemistry
5. John H. Kennedy, Analytical chemistry principles
6. Indian Pharmacopoeia.
34
BP103T. PHARMACEUTICS- I (Theory)
45 Hours
Scope: This course is designed to impart a fundamental knowledge on the preparatory
pharmacy with arts and science of preparing the different conventional dosage forms.
Objectives: Upon completion of this course the student should be able to:
? Know the history of profession of pharmacy
? Understand the basics of different dosage forms, pharmaceutical incompatibilities and
pharmaceutical calculations
? Understand the professional way of handling the prescription
? Preparation of various conventional dosage forms
Course Content:
UNIT ? I
10 Hours
? Historical background and development of profession of pharmacy: History
of profession of Pharmacy in India in relation to pharmacy education, industry
and organization, Pharmacy as a career, Pharmacopoeias: Introduction to IP, BP,
USP and Extra Pharmacopoeia.
? Dosage forms: Introduction to dosage forms, classification and definitions
? Prescription: Definition, Parts of prescription, handling of Prescription and
Errors in prescription.
? Posology: Definition, Factors affecting posology. Pediatric dose calculations
based on age, body weight and body surface area.
UNIT ? II
10 Hours
? Pharmaceutical calculations: Weights and measures ? Imperial & Metric
system, Calculations involving percentage solutions, alligation, proof spirit and
isotonic solutions based on freezing point and molecular weight.
? Powders: Definition, classification, advantages and disadvantages,Simple &
compound powders ? official preparations, dusting powders, effervescent,
efflorescent and hygroscopic powders, eutectic mixtures. Geometric dilutions.
? Liquid dosage forms: Advantages and disadvantages of liquid dosage forms.
Excipients used in formulation of liquid dosage forms. Solubility enhancement
techniques
35
UNIT ? III
08 Hours
? Monophasic liquids: Definitions and preparations of Gargles, Mouthwashes,
Throat Paint, Eardrops, Nasal drops, Enemas, Syrups, Elixirs, Liniments and
Lotions.
? Biphasic liquids:
? Suspensions: Definition, advantages and disadvantages, classifications,
Preparation of suspensions; Flocculated and Deflocculated suspension & stability
problems and methods to overcome.
? Emulsions: Definition, classification, emulsifying agent, test for the identification
of type ofEmulsion, Methods of preparation & stability problems and methods to
overcome.
UNIT ? IV
08 Hours
? Suppositories: Definition, types, advantages and disadvantages, types of bases,
methods of preparations. Displacement value & its calculations, evaluation of
suppositories.
? Pharmaceutical incompatibilities: Definition, classification, physical, chemical
and therapeutic incompatibilities with examples.
UNIV ? V
07 Hours
? Semisolid dosage forms: Definitions, classification, mechanisms and factors
influencing dermal penetration of drugs. Preparation of ointments, pastes, creams
and gels. Excipients used in semi solid dosage forms. Evaluation of semi solid
dosages forms.
36
BP109P. PHARMACEUTICSI (Practical)
3 Hours / week
1 . Syrups a) Syrup IP'66
b) Compound syrup of Ferrous Phosphate BPC'68
2. Elixirs
a) Piperazine citrate elixir
b) Paracetamol pediatric elixir
3. Linctus
a) Terpin Hydrate Linctus IP'66
b) Iodine Throat Paint (Mandles Paint)
4. Solutions
a) Strong solution of ammonium acetate
b) Cresol with soap solution
c) Lugol's solution
5. Suspensions
a) Calamine lotion
b) Magnesium Hydroxide mixture
c) Aluminimum Hydroxide gel
6. Emulsions a) Turpentine Liniment
b) Liquid paraffin emulsion
7. Powders and Granules
a) ORS powder (WHO)
b) Effervescent granules
c) Dusting powder
d) Divded powders
8. Suppositories
a) Glycero gelatin suppository
b) Coca butter suppository
c) Zinc Oxide suppository
9. Semisolids
a) Sulphur ointment
b) Non staining-iodine ointment with methyl salicylate
c) Carbopal gel
37
10.
Gargles and Mouthwashes
a) Iodine gargle
b) Chlorhexidine mouthwash
Recommended Books: (Latest Editions)
1. H.C. Ansel et al., Pharmaceutical Dosage Form and Drug Delivery System, Lippincott
Williams and Walkins, New Delhi.
2. Carter S.J., Cooper and Gunn's-Dispensing for Pharmaceutical Students, CBS publishers,
New Delhi.
3. M.E. Aulton, Pharmaceutics, The Science& Dosage Form Design, Churchill Livingstone,
Edinburgh.
4. Indian pharmacopoeia.
5. British pharmacopoeia.
6. Lachmann. Theory and Practice of Industrial Pharmacy,Lea& Febiger Publisher, The
University of Michigan.
7. Alfonso R. Gennaro Remington. The Science and Practice of Pharmacy, Lippincott
Williams, New Delhi.
8. Carter S.J., Cooper and Gunn's. Tutorial Pharmacy, CBS Publications, New Delhi.
9. E.A. Rawlins, Bentley's Text Book of Pharmaceutics, English Language Book Society,
Elsevier Health Sciences, USA.
10. Isaac Ghebre Sellassie: Pharmaceutical Pelletization Technology, Marcel Dekker, INC,
New York.
11. Dilip M. Parikh: Handbook of Pharmaceutical Granulation Technology, Marcel Dekker,
INC, New York.
12. Francoise Nieloud and Gilberte Marti-Mestres: Pharmaceutical Emulsions and
Suspensions, Marcel Dekker, INC, New York.
38
BP104T. PHARMACEUTICAL INORGANIC CHEMISTRY (Theory)
45 Hours
Scope: This subject deals with the monographs of inorganic drugs and pharmaceuticals.
Objectives: Upon completion of course student shall be able to
? Know the sources of impurities and methods to determine the impurities in
inorganic drugs and pharmaceuticals
? Understand the medicinal and pharmaceutical importance of inorganic compounds
Course Content:
UNIT I
10 Hours
? Impurities in pharmaceutical substances: History of Pharmacopoeia,
Sources and types of impurities, principle involved in the limit test for
Chloride, Sulphate, Iron, Arsenic, Lead and Heavy metals, modified limit test
for Chloride and Sulphate
General methods of preparation, assay for the compounds superscripted
with asterisk (*), properties and medicinal uses of inorganic compounds
belonging to the following classes
UNIT II
10 Hours
? Acids, Bases and Buffers: Buffer equations and buffer capacity in general,
buffers in pharmaceutical systems, preparation, stability, buffered isotonic
solutions, measurements of tonicity, calculations and methods of adjusting
isotonicity.
? Major extra and intracellular electrolytes: Functions of major
physiological ions, Electrolytes used in the replacement therapy: Sodium
chloride*, Potassium chloride, Calcium gluconate* and Oral Rehydration Salt
(ORS), Physiological acid base balance.
? Dental products: Dentifrices, role of fluoride in the treatment of dental
caries, Desensitizing agents, Calcium carbonate, Sodium fluoride, and Zinc
eugenol cement.
UNIT III
10 Hours
? Gastrointestinal agents
Acidifiers: Ammonium chloride* and Dil. HCl
Antacid: Ideal properties of antacids, combinations of antacids, Sodium
39
Bicarbonate*, Aluminum hydroxide gel, Magnesium hydroxide mixture
Cathartics: Magnesium sulphate, Sodium orthophosphate, Kaolin and
Bentonite
Antimicrobials: Mechanism, classification, Potassium permanganate, Boric
acid, Hydrogen peroxide*, Chlorinated lime*, Iodine and its preparations
UNIT IV
08 Hours
? Miscellaneous compounds
Expectorants: Potassium iodide, Ammonium chloride*.
Emetics: Copper sulphate*, Sodium potassium tartarate
Haematinics: Ferrous sulphate*, Ferrous gluconate
Poison and Antidote: Sodium thiosulphate*, Activated charcoal, Sodium
nitrite
Astringents: Zinc Sulphate, Potash Alum
UNIT V
07 Hours
? Radiopharmaceuticals: Radio activity, Measurement of radioactivity,
Properties of , , radiations, Half life, radio isotopes and study of radio
isotopes - Sodium iodide I131, Storage conditions, precautions &
pharmaceutical application of radioactive substances.
40
BP110P. PHARMACEUTICAL INORGANIC CHEMISTRY (Practical)
4 Hours / Week
I
Limit tests for following ions
Limit test for Chlorides and Sulphates
Modified limit test for Chlorides and Sulphates
Limit test for Iron
Limit test for Heavy metals
Limit test for Lead
Limit test for Arsenic
II
Identification test
Magnesium hydroxide
Ferrous sulphate
Sodium bicarbonate
Calcium gluconate
Copper sulphate
III
Test for purity
Swelling power of Bentonite
Neutralizing capacity of aluminum hydroxide gel
Determination of potassium iodate and iodine in potassium Iodide
IV
Preparation of inorganic pharmaceuticals
Boric acid
Potash alum
Ferrous sulphate
Recommended Books (Latest Editions)
1.
A.H. Beckett & J.B. Stenlake's, Practical Pharmaceutical Chemistry Vol I & II,
Stahlone Press of University of London, 4th edition.
2.
A.I. Vogel, Text Book of Quantitative Inorganic analysis
3.
P. Gundu Rao, Inorganic Pharmaceutical Chemistry, 3rd Edition
4.
M.L Schroff, Inorganic Pharmaceutical Chemistry
5.
Bentley and Driver's Textbook of Pharmaceutical Chemistry
6.
Anand & Chatwal, Inorganic Pharmaceutical Chemistry
7.
Indian Pharmacopoeia
41
BP105T. COMMUNICATION SKILLS (Theory)
30 Hours
Scope: This course will prepare the young pharmacy student to interact effectively with
doctors, nurses, dentists, physiotherapists and other health workers. At the end of this
course the student will get the soft skills set to work cohesively with the team as a team
player and will add value to the pharmaceutical business.
Objectives:
Upon completion of the course the student shall be able to
1. Understand the behavioral needs for a Pharmacist to function effectively in the
areas of pharmaceutical operation
2. Communicate effectively (Verbal and Non Verbal)
3. Effectively manage the team as a team player
4. Develop interview skills
5. Develop Leadership qualities and essentials
Course content:
UNIT ? I
07 Hours
? Communication Skills: Introduction, Definition, The Importance of Communication,
The Communication Process ? Source, Message, Encoding, Channel, Decoding,
Receiver, Feedback, Context
? Barriers to communication: Physiological Barriers, Physical Barriers, Cultural
Barriers, Language Barriers, Gender Barriers, Interpersonal Barriers, Psychological
Barriers, Emotional barriers
? Perspectives in Communication: Introduction, Visual Perception, Language, Other
factors affecting our perspective - Past Experiences, Prejudices, Feelings, Environment
UNIT ? II
07 Hours
? Elements of Communication: Introduction, Face to Face Communication - Tone of
Voice, Body Language (Non-verbal communication), Verbal Communication, Physical
Communication
? Communication Styles: Introduction, The Communication Styles Matrix with example
for each -Direct Communication Style, Spirited Communication Style, Systematic
Communication Style, Considerate Communication Style
42
UNIT ? III
07 Hours
? Basic Listening Skills: Introduction, Self-Awareness, Active Listening, Becoming an
Active Listener, Listening in Difficult Situations
? Effective Written Communication: Introduction, When and When Not to Use
Written Communication - Complexity of the Topic, Amount of Discussion'
Required, Shades of Meaning, Formal Communication
? Writing Effectively: Subject Lines, Put the Main Point First, Know Your Audience,
Organization of the Message
UNIT ? IV
05 Hours
? Interview Skills: Purpose of an interview, Do's and Dont's of an interview
? Giving Presentations: Dealing with Fears, Planning your Presentation, Structuring Your
Presentation, Delivering Your Presentation, Techniques of Delivery
UNIT ? V
04 Hours
? Group Discussion: Introduction, Communication skills in group discussion, Do's and
Dont's of group discussion
43
BP111P. COMMUNICATION SKILLS (Practical)
2 Hours / week
The following learning modules are to be conducted using wordsworth? English
language lab software
Basic communication covering the following topics
Meeting People
Asking Questions
Making Friends
What did you do?
Do's and Dont's
Pronunciations covering the following topics
Pronunciation (Consonant Sounds)
Pronunciation and Nouns
Pronunciation (Vowel Sounds)
Advanced Learning
Listening Comprehension / Direct and Indirect Speech
Figures of Speech
Effective Communication
Writing Skills
Effective Writing
Interview Handling Skills
E-Mail etiquette
Presentation Skills
44
Recommended Books: (Latest Edition)
1. Basic communication skills for Technology, Andreja. J. Ruther Ford, 2nd Edition,
Pearson Education, 2011
2. Communication skills, Sanjay Kumar, Pushpalata, 1stEdition, Oxford Press, 2011
3. Organizational Behaviour, Stephen .P. Robbins, 1stEdition, Pearson, 2013
4. Brilliant- Communication skills, Gill Hasson, 1stEdition, Pearson Life, 2011
5. The Ace of Soft Skills: Attitude, Communication and Etiquette for success, Gopala
Swamy Ramesh, 5thEdition, Pearson, 2013
6. Developing your influencing skills, Deborah Dalley, Lois Burton, Margaret, Green
hall, 1st Edition Universe of Learning LTD, 2010
7. Communication skills for professionals, Konar nira, 2ndEdition, New arrivals ?
PHI, 2011
8. Personality development and soft skills, Barun K Mitra, 1stEdition, Oxford Press,
2011
9. Soft skill for everyone, Butter Field, 1st Edition, Cengage Learning india pvt.ltd,
2011
10. Soft skills and professional communication, Francis Peters SJ, 1stEdition, Mc
Graw Hill Education, 2011
11. Effective communication, John Adair, 4thEdition, Pan Mac Millan,2009
12. Bringing out the best in people, Aubrey Daniels, 2ndEdition, Mc Graw Hill, 1999
45
BP 106RBT. REMEDIAL BIOLOGY (Theory)
30 Hours
Scope: To learn and understand the components of living world, structure and functional
system of plant and animal kingdom.
Objectives: Upon completion of the course, the student shall be able to
? know the classification and salient features of five kingdoms of life
? understand the basic components of anatomy & physiology of plant
? know understand the basic components of anatomy & physiology animal with
special reference to human
UNIT I
07 Hours
Living world:
? Definition and characters of living organisms
? Diversity in the living world
? Binomial nomenclature
? Five kingdoms of life and basis of classification. Salient features of Monera,
Potista, Fungi, Animalia and Plantae, Virus,
Morphology of Flowering plants
? Morphology of different parts of flowering plants ? Root, stem, inflorescence,
flower, leaf, fruit, seed.
? General Anatomy of Root, stem, leaf of monocotyledons & Dicotylidones.
UNIT II
07 Hours
Body fluids and circulation
? Composition of blood, blood groups, coagulation of blood
? Composition and functions of lymph
? Human circulatory system
? Structure of human heart and blood vessels
? Cardiac cycle, cardiac output and ECG
Digestion and Absorption
? Human alimentary canal and digestive glands
? Role of digestive enzymes
? Digestion, absorption and assimilation of digested food
Breathing and respiration
? Human respiratory system
? Mechanism of breathing and its regulation
? Exchange of gases, transport of gases and regulation of respiration
? Respiratory volumes
46
UNIT III
07 Hours
Excretory products and their elimination
? Modes of excretion
? Human excretory system- structure and function
? Urine formation
? Rennin angiotensin system
Neural control and coordination
? Definition and classification of nervous system
? Structure of a neuron
? Generation and conduction of nerve impulse
? Structure of brain and spinal cord
? Functions of cerebrum, cerebellum, hypothalamus and medulla oblongata
Chemical coordination and regulation
? Endocrine glands and their secretions
? Functions of hormones secreted by endocrine glands
Human reproduction
? Parts of female reproductive system
? Parts of male reproductive system
? Spermatogenesis and Oogenesis
? Menstrual cycle
UNIT IV
05 Hours
Plants and mineral nutrition:
? Essential mineral, macro and micronutrients
? Nitrogen metabolism, Nitrogen cycle, biological nitrogen fixation
Photosynthesis
? Autotrophic nutrition, photosynthesis, Photosynthetic pigments, Factors affecting
photosynthesis.
UNIT V
04 Hours
Plant respiration: Respiration, glycolysis, fermentation (anaerobic).
Plant growth and development
? Phases and rate of plant growth, Condition of growth,Introduction to plant growth
regulators
Cell - The unit of life
? Structure and functions of cell and cell organelles.Cell division
Tissues
? Definition, types of tissues, location and functions.
47
Text Books
a. Text book of Biology by S. B. Gokhale
b. A Text book of Biology by Dr. Thulajappa and Dr. Seetaram.
Reference Books
a. A Text book of Biology by B.V. Sreenivasa Naidu
b. A Text book of Biology by Naidu and Murthy
c. Botany for Degree students By A.C.Dutta.
d. Outlines of Zoology by M. Ekambaranatha ayyer and T. N. Ananthakrishnan.
e. A manual for pharmaceutical biology practical by S.B. Gokhale and C. K. Kokate
48
BP112R BP.REMEDIAL BIOLOGY (Practical)
30 Hours
1. Introduction to experiments in biology
a) Study of Microscope
b) Section cutting techniques
c) Mounting and staining
d) Permanent slide preparation
2. Study of cell and its inclusions
3. Study of Stem, Root, Leaf, seed, fruit, flower and their modifications
4. Detailed study of frog byusing computer models
5. Microscopic study and identification of tissues pertinent to Stem, Root
Leaf, seed, fruit and flower
6. Identification of bones
7. Determination of blood group
8. Determination of blood pressure
9. Determination of tidal volume
Reference Books
1. Practical human anatomy and physiology. by S.R.Kale and R.R.Kale.
2. A Manual of pharmaceutical biology practical by S.B.Gokhale, C.K.Kokateand
S.P.Shriwastava.
3. Biology practical manual according to National core curriculum .Biologyforum of
Karnataka. Prof .M.J.H.Shafi
49
BP 106 RMT. REMEDIAL MATHEMATICS (Theory)
30 Hours
Scope: This is an introductory course in mathematics. This subject deals with the
introduction to Partial fraction, Logarithm, matrices and Determinant, Analytical
geometry, Calculus, differential equation and Laplace transform.
Objectives:Upon completion of the course the student shall be able to:-
1. Know the theory and their application in Pharmacy
2. Solve the different types of problems by applying theory
3. Appreciate the important application of mathematics in Pharmacy
Course Content:
UNIT ? I
06 Hours
? Partial fraction
Introduction, Polynomial, Rational fractions, Proper and Improper fractions,
Partial fraction , Resolving into Partial fraction, Application of Partial
Fraction in Chemical Kinetics and Pharmacokinetics
? Logarithms
Introduction, Definition, Theorems/Properties of logarithms, Common
logarithms, Characteristic and Mantissa, worked examples, application of
logarithm to solve pharmaceutical problems.
? Function:
Real Valued function, Classification of real valued functions,
? Limits and continuity:
Introduction, Limit of a function, Definition of limit of a function ( -
definition) , lim xn -a n = nan-1 , lim sin = 1,
xa
x - a
0
UNIT ?II
06 Hours
? Matrices and Determinant:
Introduction matrices, Types of matrices, Operation on matrices, Transpose
of a matrix, Matrix Multiplication, Determinants, Properties of determinants ,
Product of determinants, Minors and co-Factors, Adjoint or adjugate of a
square matrix, Singular and non-singular matrices, Inverse of a matrix,
Solution of system of linear of equations using matrix method, Cramer's rule,
Characteristic equation and roots of a square matrix, Cayley?Hamilton
theorem, Application of Matrices in solving Pharmacokinetic equations
50
UNIT ? III
06 Hours
? Calculus Differentiation : Introductions, Derivative of a function, Derivative of a
constant, Derivative of a product of a constant and a function , Derivative of the sum
or difference of two functions, Derivative of the product of two functions (product
formula), Derivative of the quotient of two functions (Quotient formula) ? Without
Proof, Derivative of xn w.r.tx,where n is any rational number, Derivative of ex,,
Derivative of loge x , Derivative of ax,Derivative of trigonometric functions from
first principles (without Proof), Successive Differentiation, Conditions for a
function to be a maximum or a minimum at a point. Application
UNIT ? IV
06 Hours
? Analytical Geometry
Introduction: Signs of the Coordinates, Distance formula,
Straight Line : Slope or gradient of a straight line, Conditions for
parallelism and perpendicularity of two lines, Slope of a line joining two
points, Slope ? intercept form of a straight line
Integration:
Introduction, Definition, Standard formulae, Rules of integration, Method of
substitution, Method of Partial fractions, Integration by parts, definite
integrals, application
UNIT-V
06 Hours
? Differential Equations : Some basic definitions, Order and degree, Equations
in separable form , Homogeneous equations, Linear Differential equations,
Exact equations, Application in solving Pharmacokinetic equations
? Laplace Transform : Introduction, Definition, Properties of Laplace
transform, Laplace Transforms of elementary functions, Inverse Laplace
transforms, Laplace transform of derivatives, Application to solve Linear
differential equations, Application in solving Chemical kinetics and
Pharmacokinetics equations
Recommended Books (Latest Edition)
1. Differential Calculus by Shanthinarayan
2. Pharmaceutical Mathematics with application to Pharmacy by Panchaksharappa
Gowda D.H.
3. Integral Calculus by Shanthinarayan
4. Higher Engineering Mathematics by Dr.B.S.Grewal
51
Semester II
52
BP 201T. HUMAN ANATOMY AND PHYSIOLOGY-II (Theory)
45 Hours
Scope: This subject is designed to impart fundamental knowledge on the structure and
functions of the various systems of the human body. It also helps in understanding both
homeostatic mechanisms. The subject provides the basic knowledge required to
understand the various disciplines of pharmacy.
Objectives: Upon completion of this course the student should be able to:
1.
Explain the gross morphology, structure and functions of various organs of the
human body.
2.
Describe the various homeostatic mechanisms and their imbalances.
3.
Identify the various tissues and organs of different systems of human body.
4.
Perform the hematological tests like blood cell counts, haemoglobin estimation,
bleeding/clotting time etc and also record blood pressure, heart rate, pulse and
respiratory volume.
5.
Appreciate coordinated working pattern of different organs of each system
6.
Appreciate the interlinked mechanisms in the maintenance of normal functioning
(homeostasis) of human body.
Course Content:
Unit I
10 hours
? Nervous system
Organization of nervous system, neuron, neuroglia, classification and
properties of nerve fibre, electrophysiology, action potential, nerve
impulse, receptors, synapse, neurotransmitters.
Central nervous system: Meninges, ventricles of brain and cerebrospinal
fluid.structure and functions of brain (cerebrum, brain stem, cerebellum),
spinal cord (gross structure, functions of afferent and efferent nerve tracts,
reflex activity)
Unit II
06 hours
? Digestive system
Anatomy of GI Tract with special reference to anatomy and functions of stomach,
(Acid production in the stomach, regulation of acid production through
parasympathetic nervous system, pepsin role in protein digestion) small intestine
and large intestine, anatomy and functions of salivary glands, pancreas and liver,
movements of GIT, digestion and absorption of nutrients and disorders of GIT.
? Energetics
Formation and role of ATP, Creatinine Phosphate and BMR.
53
Unit III
? Respiratory system
10 hours
Anatomy of respiratory system with special reference to anatomy of lungs,
mechanism of respiration, regulation of respiration
Lung Volumes and capacities transport of respiratory gases, artificial respiration,
and resuscitation methods.
? Urinary system
Anatomy of urinary tract with special reference to anatomy of kidney and
nephrons, functions of kidney and urinary tract, physiology of urine formation,
micturition reflex and role of kidneys in acid base balance, role of RAS in kidney
and disorders of kidney.
Unit IV
10 hours
? Endocrine system
Classification of hormones, mechanism of hormone action, structure and
functions of pituitary gland, thyroid gland, parathyroid gland, adrenal gland,
pancreas, pineal gland, thymus and their disorders.
Unit V
09 hours
? Reproductive system
Anatomy of male and female reproductive system, Functions of male and female
reproductive system, sex hormones, physiology of menstruation, fertilization,
spermatogenesis, oogenesis, pregnancy and parturition
? Introduction to genetics
Chromosomes, genes and DNA, protein synthesis, genetic pattern of inheritance.
54
BP 207 P. HUMAN ANATOMY AND PHYSIOLOGY (Practical)
4 Hours/week
Practical physiology is complimentary to the theoretical discussions in physiology.
Practicals allow the verification of physiological processes discussed in theory classes
through experiments on living tissue, intact animals or normal human beings. This is
helpful for developing an insight on the subject.
1. To study the integumentary and special senses using specimen, models, etc.,
2. To study the nervous system using specimen, models, etc.,
3. To study the endocrine system using specimen, models, etc
4. To demonstrate the general neurological examination
5. To demonstrate the function of olfactory nerve
6. To examine the different types of taste.
7. To demonstrate the visual acuity
8. To demonstrate the reflex activity
9. Recording of body temperature
10. To demonstrate positive and negative feedback mechanism.
11. Determination of tidal volume and vital capacity.
12. Study of digestive, respiratory, cardiovascular systems, urinary and reproductive
systems with the help of models, charts and specimens.
13. Recording of basal mass index
.
14. Study of familyplanning devices and pregnancy diagnosis test.
15. Demonstration of total blood count by cell analyser
16. Permanent slides of vital organs and gonads.
55
Recommended Books (Latest Editions)
1. Essentials of Medical Physiology by K. Sembulingam and P. Sembulingam. Jaypee
brothers medical publishers, New Delhi.
2. Anatomy and Physiology in Health and Illness by Kathleen J.W. Wilson, Churchill
Livingstone, New York
3. Physiological basis of Medical Practice-Best and Tailor. Williams & Wilkins
Co,Riverview,MI USA
4. Text book of Medical Physiology- Arthur C,Guyton andJohn.E. Hall. Miamisburg, OH,
U.S.A.
5. Principles of Anatomy and Physiology by Tortora Grabowski. Palmetto, GA, U.S.A.
6. Textbook of Human Histology by Inderbir Singh, Jaypee brothers medical publishers,
New Delhi.
7. Textbook of Practical Physiology by C.L. Ghai, Jaypee brothers medical publishers, New
Delhi.
8. Practical workbook of Human Physiology by K. Srinageswari and Rajeev Sharma,
Jaypee brother's medical publishers, New Delhi.
Reference Books:
1. Physiological basis of Medical Practice-Best and Tailor. Williams & Wilkins Co,
Riverview, MI USA
2. Text book of Medical Physiology- Arthur C, Guyton and John. E. Hall. Miamisburg, OH,
U.S.A.
3. Human Physiology (vol 1 and 2) by Dr. C.C. Chatterrje ,Academic Publishers Kolkata
56
BP202T. PHARMACEUTICAL ORGANIC CHEMISTRY ?I (Theory)
45 Hours
Scope: This subject deals with classification and nomenclature of simple organic
compounds, structural isomerism, intermediates forming in reactions, important physical
properties, reactions and methods of preparation of these compounds. The syllabus also
emphasizes on mechanisms and orientation of reactions.
Objectives: Upon completion of the course the student shall be able to
1. write the structure, name and the type of isomerism of the organic compound
2. write the reaction, name the reaction and orientation of reactions
3. account for reactivity/stability of compounds,
4. identify/confirm the identification of organic compound
Course Content:
General methods of preparation and reactions of compounds superscripted with asterisk (*) to be
explained
To emphasize on definition, types, classification, principles/mechanisms, applications, examples
and differences
UNIT-I
07 Hours
? Classification, nomenclature and isomerism
Classification of Organic Compounds
Common and IUPAC systems of nomenclature of organic compounds
(up to 10 Carbons open chain and carbocyclic compounds)
Structural isomerisms in organic compounds
UNIT-II
10 Hours
? Alkanes*, Alkenes* and Conjugated dienes*
SP3 hybridization in alkanes, Halogenation of alkanes, uses of paraffins.
Stabilities of alkenes, SP2 hybridization in alkenes
E1 and E2 reactions ? kinetics, order of reactivity of alkyl halides, rearrangement of
carbocations, Saytzeffs orientation and evidences. E1 verses E2 reactions, Factors affecting E1
and E2 reactions. Ozonolysis, electrophilic addition reactions of alkenes, Markownikoff's
orientation, free radical addition reactions of alkenes, Anti Markownikoff's orientation.
Stability of conjugated dienes, Diel-Alder, electrophilic addition, free radical addition
reactions of conjugated dienes, allylic rearrangement
57
UNIT-III
10 Hours
? Alkyl halides*
SN1 and SN2 reactions - kinetics, order of reactivity of alkyl halides, stereochemistry and
rearrangement of carbocations.
SN1 versus SN2 reactions, Factors affecting SN1 and SN2 reactions
Structure and uses of ethylchloride, Chloroform, trichloroethylene, tetrachloroethylene,
dichloromethane, tetrachloromethane and iodoform.
? Alcohols*- Qualitative tests, Structure and uses of Ethyl alcohol, Methyl alcohol,
chlorobutanol, Cetosteryl alcohol, Benzyl alcohol, Glycerol, Propylene glycol
UNIT-IV
10 Hours
? Carbonyl compounds* (Aldehydes and ketones)
Nucleophilic addition, Electromeric effect, aldol condensation, Crossed Aldol condensation,
Cannizzaro reaction, Crossed Cannizzaro reaction, Benzoin condensation, Perkin
condensation, qualitative tests, Structure and uses of Formaldehyde, Paraldehyde, Acetone,
Chloral hydrate, Hexamine, Benzaldehyde, Vanilin, Cinnamaldehyde.
UNIT-V
08 Hours
? Carboxylic acids*
Acidity of carboxylic acids, effect of substituents on acidity, inductive effect and qualitative
tests for carboxylic acids ,amide and ester
Structure and Uses of Acetic acid, Lactic acid, Tartaric acid, Citric acid, Succinic acid. Oxalic
acid, Salicylic acid, Benzoic acid, Benzyl benzoate, Dimethyl phthalate, Methyl salicylate and
Acetyl salicylic acid
? Aliphatic amines* - Basicity, effect of substituent on Basicity. Qualitative test, Structure and
uses of Ethanolamine, Ethylenediamine, Amphetamine
58
BP208P. PHARMACEUTICAL ORGANIC CHEMISTRY - I (Practical)
4 Hours / week
1.
Systematic qualitative analysis of unknown organic compounds like
1. Preliminary test: Color, odour, aliphatic/aromatic compounds, saturation
and unsaturation, etc.
2. Detection of elements like Nitrogen, Sulphur and Halogen by
Lassaigne's test
3. Solubility test
4. Functional group test like Phenols, Amides/ Urea, Carbohydrates,
Amines, Carboxylic acids, Aldehydes and Ketones, Alcohols, Esters,
Aromatic and Halogenated Hydrocarbons, Nitro compounds and
Anilides.
5. Melting point/Boiling point of organic compounds
6. Identification of the unknown compound from the literature using
melting point/ boiling point.
7. Preparation of the derivatives and confirmation of the unknown
compound by melting point/ boiling point.
8. Minimum 5 unknown organic compounds to be analysed systematically.
2.
Preparation of suitable solid derivatives from organic compounds
3.
Construction of molecular models
Recommended Books (Latest Editions)
1. Organic Chemistry by Morrison and Boyd
2. Organic Chemistry by I.L. Finar , Volume-I
3. Textbook of Organic Chemistry by B.S. Bahl & Arun Bahl.
4. Organic Chemistry by P.L.Soni
5. Practical Organic Chemistry by Mann and Saunders.
6. Vogel's text book of Practical Organic Chemistry
7. Advanced Practical organic chemistry by N.K.Vishnoi.
8. Introduction to Organic Laboratory techniques by Pavia, Lampman and Kriz.
9. Reaction and reaction mechanism by Ahluwaliah/Chatwal.
59
BP203 T. BIOCHEMISTRY (Theory)
45 Hours
Scope: Biochemistry deals with complete understanding of the molecular levels of the
chemical process associated with living cells. The scope of the subject is providing
biochemical facts and the principles to understand metabolism of nutrient molecules in
physiological and pathological conditions. It is also emphasizing on genetic organization
of mammalian genome and hetero & autocatalytic functions of DNA.
Objectives: Upon completion of course student shell able to
1. Understand the catalytic role of enzymes, importance of enzyme inhibitors in
design of new drugs, therapeutic and diagnostic applications of enzymes.
2. Understand the metabolism of nutrient molecules in physiological and
pathological conditions.
3. Understand the genetic organization of mammalian genome and functions of
DNA in the synthesis of RNAs and proteins.
Course Content:
UNIT I
08 Hours
? Biomolecules
Introduction, classification, chemical nature and biological role of carbohydrate,
lipids, nucleic acids, amino acids and proteins.
? Bioenergetics
Concept of free energy, endergonic and exergonic reaction, Relationship between free
energy, enthalpy and entropy; Redox potential.
Energy rich compounds; classification; biological significances of ATP and cyclic
AMP
UNIT II
10 Hours
? Carbohydrate metabolism
Glycolysis ? Pathway, energetics and significance
Citric acid cycle- Pathway, energetics and significance
HMP shunt and its significance; Glucose-6-Phosphate dehydrogenase (G6PD)
deficiency
Glycogen metabolism Pathways and glycogen storage diseases (GSD)
Gluconeogenesis- Pathway and its significance
Hormonal regulation of blood glucose level and Diabetes mellitus
? Biological oxidation: Electron transport chain (ETC) and its mechanism.
Oxidative phosphorylation & its mechanism and substrate level phosphorylation.
Inhibitors ETC and oxidative phosphorylation/Uncouplers.
60
UNIT III
10 Hours
? Lipid metabolism
-Oxidation of saturated fatty acid (Palmitic acid)
Formation and utilization of ketone bodies; ketoacidosis
De novo synthesis of fatty acids (Palmitic acid)
Biological significance of cholesterol and conversion of cholesterol into
bile acids, steroid hormone and vitamin D
Disorders of lipid metabolism: Hypercholesterolemia, atherosclerosis,
fatty liver and obesity.
? Amino acid metabolism
General reactions of amino acid metabolism: Transamination,
deamination & decarboxylation, urea cycle and its disorders
Catabolism of phenylalanine and tyrosine and their metabolic disorders
(Phenyketonuria, Albinism, alkeptonuria, tyrosinemia)
Synthesis and significance of biological substances; 5-HT, melatonin,
dopamine, noradrenaline, adrenaline
Catabolism of heme; hyperbilirubinemia and jaundice
UNIT IV
10 Hours
? Nucleic acid metabolism and genetic information transfer
Biosynthesis of purine and pyrimidine nucleotides
Catabolism of purine nucleotides and Hyperuricemia and Gout disease
Organization of mammalian genome
Structure of DNA and RNA and their functions
DNA replication (semi conservative model)
Transcription or RNA synthesis
Genetic code, Translation or Protein synthesis and inhibitors
UNIT V
07 Hours
? Enzymes
Introduction, properties, nomenclature and IUB classification of enzymes
Enzyme kinetics (Michaelis plot, Line Weaver Burke plot)
Enzyme inhibitors with examples
Regulation of enzymes: enzyme induction and repression, allosteric
enzymes regulation
Therapeutic and diagnostic applications of enzymes and isoenzymes
Coenzymes ?Structure and biochemical functions
61
BP 209 P. BIOCHEMISTRY (Practical)
4 Hours / Week
1.
Qualitative analysis of carbohydrates (Glucose, Fructose, Lactose, Maltose,
Sucrose and starch)
2.
Identification tests for Proteins (albumin and Casein)
3.
Quantitative analysis of reducing sugars (DNSA method) and Proteins
(Biuret method)
4.
Qualitative analysis of urine for abnormal constituents
5.
Determination of blood creatinine
6.
Determination of blood sugar
7.
Determination of serum total cholesterol
8.
Preparation of buffer solution and measurement of pH
9.
Study of enzymatic hydrolysis of starch
10. Determination of Salivary amylase activity
11. Study the effect of Temperature on Salivary amylase activity.
12. Study the effect of substrate concentration on salivary amylase activity.
Recommended Books (Latest Editions)
1. Principles of Biochemistry by Lehninger.
2. Harper's Biochemistry by Robert K. Murry, Daryl K. Granner and Victor W. Rodwell.
3. Biochemistry by Stryer.
4. Biochemistry by D. Satyanarayan and U.Chakrapani
5. Textbook of Biochemistry by Rama Rao.
6. Textbook of Biochemistry by Deb.
7. Outlines of Biochemistry by Conn and Stumpf
8. Practical Biochemistry by R.C. Gupta and S. Bhargavan.
9. Introduction of Practical Biochemistry by David T. Plummer. (3rd Edition)
10. Practical Biochemistry for Medical students by Rajagopal and Ramakrishna.
11. Practical Biochemistry by Harold Varley.
62
BP 204T.PATHOPHYSIOLOGY (THEORY)
45Hours
Scope: Pathophysiology is the study of causes of diseases and reactions of the body to
such disease producing causes.This course is designed to impart a thorough knowledge of
the relevant aspects of pathology of various conditions with reference to its
pharmacological applications, and understanding of basic pathophysiological mechanisms.
Hence it will not only help to study the syllabus of pathology, but also to get baseline
knowledge required to practice medicine safely, confidently, rationally and effectively.
Objectives: Upon completion of the subject student shall be able to ?
1. Describe the etiology and pathogenesis of the selected diseasestates;
2. Name the signs and symptoms of the diseases; and
3. Mention the complications of the diseases.
Course content:
Unit I
10 Hours
? Basic principles of Cell injury and Adaptation:
Introduction, definitions, Homeostasis, Components and Types of Feedback systems,
Causes of cellular injury,Pathogenesis (Cell membrane damage, Mitochondrial damage,
Ribosome damage, Nuclear damage),Morphology of cell injury ? Adaptive changes
(Atrophy, Hypertrophy, hyperplasia, Metaplasia, Dysplasia),Cell swelling, Intra cellular
accumulation, Calcification, Enzyme leakage and Cell Death Acidosis &Alkalosis,
Electrolyte imbalance.
? Basic mechanism involved in the process of inflammation and repair:
Introduction, Clinical signs of inflammation, Different types of Inflammation,Mechanism of
Inflammation ? Alteration in vascular permeability and blood flow, migration of
WBC's,Mediators of inflammation,Basic principles of wound healing in the
skin,Pathophysiology of Atherosclerosis
Unit II
10 Hours
? Cardiovascular System:
Hypertension, congestive heart failure, ischemic heart disease (angina, myocardial
infarction, atherosclerosis and arteriosclerosis)
? Respiratory system: Asthma, Chronic obstructive airways diseases.
? Renal system: Acute and chronic renal failure .
63
Unit III
10 Hours
? Haematological Diseases:
Iron deficiency, megaloblastic anemia (Vit B12 and folic acid), sickle cell anemia,
thalasemia, hereditary acquired anemia, hemophilia
? Endocrine system: Diabetes, thyroid diseases, disorders of sex hormones
? Nervous system: Epilepsy, Parkinson's disease, stroke, psychiatric disorders:
depression, schizophrenia and Alzheimer's disease.
? Gastrointestinal system: Peptic Ulcer
Unit IV
8 Hours
? Inflammatory bowel diseases, jaundice, hepatitis (A,B,C,D,E,F) alcoholic liver
disease.
? Disease of bones and joints: Rheumatoid arthritis, osteoporosis and gout
? Cancer: Classification, etiology and pathogenesis of cancer
Unit V
7 Hours
? Infectious diseases: Meningitis,Typhoid, Leprosy, Tuberculosis, Urinary tract infections
? Sexually transmitted diseases:AIDS, Syphilis, Gonorrhea
64
Recommended Books (Latest Editions)
1. Vinay Kumar, Abul K. Abas, Jon C. Aster; Robbins &Cotran Pathologic Basis of
Disease; South Asia edition; India; Elsevier; 2014.
2. Harsh Mohan; Text book of Pathology; 6th edition; India; Jaypee Publications; 2010.
3. Laurence B, Bruce C, Bjorn K. ; Goodman Gilman's The Pharmacological Basis of
Therapeutics; 12th edition; New York; McGraw-Hill; 2011.
4. Best, Charles Herbert 1899-1978; Taylor, Norman Burke 1885-1972; West, John B
(John Burnard); Best and Taylor's Physiological basis of medical practice; 12th ed;
united states;
5. William and Wilkins, Baltimore;1991 [1990 printing].
6. Nicki R. Colledge, Brian R. Walker, Stuart H. Ralston;Davidson's Principles and Practice
of Medicine; 21st edition; London; ELBS/Churchill Livingstone; 2010.
7. Guyton A, John .E Hall; Textbook of Medical Physiology; 12th edition; WB Saunders
Company; 2010.
8. Joseph DiPiro, Robert L. Talbert, Gary Yee, Barbara Wells, L. Michael Posey;
Pharmacotherapy: A Pathophysiological Approach; 9th edition; London; McGraw-Hill
Medical; 2014.
9. V. Kumar, R. S. Cotran and S. L. Robbins; Basic Pathology; 6th edition; Philadelphia;
WB Saunders Company; 1997.
10. Roger Walker, Clive Edwards; Clinical Pharmacy and Therapeutics; 3rd edition; London;
Churchill Livingstone publication; 2003.
Recommended Journals
1. The Journal of Pathology. ISSN: 1096-9896 (Online)
2. The American Journal of Pathology. ISSN: 0002-9440
3. Pathology. 1465-3931 (Online)
4. International Journal of Physiology, Pathophysiology and Pharmacology. ISSN: 1944-8171
(Online)
5. Indian Journal of Pathology and Microbiology. ISSN-0377-4929.
65
BP205 T. COMPUTER APPLICATIONS IN PHARMACY (Theory)
30 Hrs (2 Hrs/Week)
Scope: This subject deals with the introduction Database, Database Management system,
computer application in clinical studies and use of databases.
Objectives: Upon completion of the course the student shall be able to
1. Know the various types of application of computers in pharmacy
2. Know the various types of databases
3. Know the various applications of databases in pharmacy
Course content:
UNIT ? I
06 hours
Number system: Binary number system, Decimal number system, Octal
number system, Hexadecimal number systems, conversion decimal to
binary, binary to decimal, octal to binary etc, binary addition, binary
subtraction ? One's complement ,Two's complement method, binary
multiplication, binary division.
Concept of Information Systems and Software : Information gathering,
requirement and feasibility analysis, data flow diagrams, process specifications,
input/output design, process life cycle, planning and managing the project
UNIT ?II
06 hours
Web technologies: Introduction to HTML, XML,CSS and Programming
languages, introduction to web servers and Server Products
Introduction to databases, MYSQL, MS ACCESS, Pharmacy Drug
database
UNIT ? III
06 hours
Application of computers in Pharmacy ? Drug information storage and
retrieval, Pharmacokinetics, Mathematical model in Drug design, Hospital
and Clinical Pharmacy, Electronic Prescribing and discharge (EP) systems,
barcode medicine identification and automated dispensing of drugs, mobile
technology and adherence monitoring
Diagnostic System, Lab-diagnostic System, Patient Monitoring System,
Pharma Information System
66
UNIT ? IV
06 hours
Bioinformatics: Introduction, Objective of Bioinformatics, Bioinformatics
Databases, Concept of Bioinformatics, Impact of Bioinformatics in Vaccine
Discovery
UNIT-V
06 hours
Computers as data analysis in Preclinical development: Chromatographic
dada analysis (CDS), Laboratory Information management System (LIMS)
and Text Information Management System(TIMS)
67
BP210P. COMPUTER APPLICATIONS IN PHARMACY (Practical)
1.
Design a questionnaire using a word processing package to gather information
about a particular disease.
2.
Create a HTML web page to show personal information.
3
Retrieve the information of a drug and its adverse effects using online tools
4
Creating mailing labels Using Label Wizard , generating label in MS WORD
5
Create a database in MS Access to store the patient information with the required
fields Using access
6.
Design a form in MS Access to view, add, delete and modify the patient record in
the database
7.
Generating report and printing the report from patient database
8.
Creating invoice table using ? MS Access
9.
Drug information storage and retrieval using MS Access
10.
Creating and working with queries in MS Access
11.
Exporting Tables, Queries, Forms and Reports to web pages
12.
Exporting Tables, Queries, Forms and Reports to XML pages
Recommended books (Latest edition):
1. Computer Application in Pharmacy ? William E.Fassett ?Lea and Febiger, 600
South Washington Square, USA, (215) 922-1330.
2. Computer Application in Pharmaceutical Research and Development ?Sean Ekins ?
Wiley-Interscience, A John Willey and Sons, INC., Publication, USA
3. Bioinformatics (Concept, Skills and Applications) ? S.C.Rastogi-CBS Publishers and
Distributors, 4596/1- A, 11 Darya Gani, New Delhi ? 110 002(INDIA)
4. Microsoft office Access - 2003, Application Development Using VBA, SQLServer,
DAP and Infopath ? Cary N.Prague ? Wiley Dreamtech India (P) Ltd., 4435/7,
Ansari Road, Daryagani, New Delhi - 110002
68
BP 206 T. ENVIRONMENTAL SCIENCES (Theory)
30 hours
Scope: Environmental Sciences is the scientific study of the environmental system and the
status of its inherent or induced changes on organisms. It includes not only the study of
physical and biological characters of the environment but also the social and cultural
factors and the impact of man on environment.
Objectives: Upon completion of the course the student shall be able to:
1. Create the awareness about environmental problems among learners.
2. Impart basic knowledge about the environment and its allied problems.
3. Develop an attitude of concern for the environment.
4. Motivate learner to participate in environment protection and environment
improvement.
5. Acquire skills to help the concerned individuals in identifying and solving
environmental problems.
6. Strive to attain harmony with Nature.
Course content:
Unit-I
10hours
The Multidisciplinary nature of environmental studies
Natural Resources
Renewable and non-renewable resources:
Natural resources and associated problems
a) Forest resources; b) Water resources; c) Mineral resources; d) Food
resources; e) Energy resources; f) Land resources: Role of an individual in
conservation of natural resources.
Unit-II
10hours
Ecosystems
Concept of an ecosystem.
Structure and function of an ecosystem.
Introduction, types, characteristic features, structure and function of
the ecosystems: Forest ecosystem; Grassland ecosystem; Desert
ecosystem; Aquatic ecosystems (ponds, streams, lakes, rivers, oceans,
estuaries)
Unit- III
10hours
Environmental Pollution: Air pollution; Water pollution; Soil pollution
69
Recommended Books (Latest edition):
1.
Y.K. Sing, Environmental Science, New Age International Pvt, Publishers,
Bangalore
2.
Agarwal, K.C. 2001 Environmental Biology, Nidi Publ. Ltd. Bikaner.
3.
Bharucha Erach, The Biodiversity of India, Mapin Pu blishing Pvt. Ltd.,
Ahmedabad ? 380 013, India,
4.
Brunner R.C., 1989, Hazardous Waste Incineration, McGraw Hill Inc. 480p
5.
Clark R.S., Marine Pollution, Clanderson Press Oxford
6.
Cunningham, W.P. Cooper, T.H. Gorhani, E & Hepworth, M.T. 2001,
Environmental Encyclopedia, Jaico Publ. House, Mumbai, 1196p
7.
De A.K., Environmental Chemistry, Wiley Eastern Ltd.
8.
Down of Earth, Centre for Science and Environment
70
SEMESTER III
71
P301T. PHARMACEUTICAL ORGANIC CHEMISTRY ?II (Theory)
45 Hours
Scope: This subject deals with general methods of preparation and reactions of some
organic compounds. Reactivity of organic compounds are also studied here. The syllabus
emphasizes on mechanisms and orientation of reactions. Chemistry of fats and oils are
also included in the syllabus.
Objectives: Upon completion of the course the student shall be able to
1. write the structure, name and the type of isomerism of the organic compound
2. write the reaction, name the reaction and orientation of reactions
3. account for reactivity/stability of compounds,
4. prepare organic compounds
Course Content:
General methods of preparation and reactions of compounds superscripted with asterisk (*) to be
explained
To emphasize on definition, types, classification, principles/mechanisms, applications, examples
and differences
UNIT I
10 Hours
? Benzene and its derivatives
A. Analytical, synthetic and other evidences in the derivation of structure
of benzene, Orbital picture, resonance in benzene, aromatic characters,
Huckel's rule
B. Reactions of benzene - nitration, sulphonation, halogenation-
reactivity, Friedelcrafts alkylation- reactivity, limitations, Friedel crafts
acylation.
C. Substituents, effect of substituents on reactivity and orientation of
mono substituted benzene compounds towards electrophilic
substitution reaction
D. Structure and uses of DDT, Saccharin, BHC and Chloramine
UNIT II
10 Hours
? Phenols* - Acidity of phenols, effect of substituents on acidity, qualitative tests,
Structure and uses of phenol, cresols, resorcinol, naphthols
? Aromatic Amines* - Basicity of amines, effect of substituents on basicity, and
synthetic uses of aryl diazonium salts
? Aromatic Acids* ?Acidity, effect of substituents on acidity and important reactions
of benzoic acid.
72
UNIT III
10 Hours
? Fats and Oils
a. Fatty acids ? reactions.
b. Hydrolysis, Hydrogenation, Saponification and Rancidity of oils, Drying oils.
c. Analytical constants ? Acid value, Saponification value, Ester value, Iodine value,
Acetyl value, Reichert Meissl (RM) value ? significance and principle involved in their
determination.
UNIT IV
08 Hours
? Polynuclear hydrocarbons:
a. Synthesis, reactions
b. Structure and medicinal uses of Naphthalene, Phenanthrene, Anthracene,
Diphenylmethane, Triphenylmethane and their derivatives
UNIT V
07 Hours
? Cyclo alkanes*
Stabilities ? Baeyer's strain theory, limitation of Baeyer's strain theory, Coulson and
Moffitt's modification, Sachse Mohr's theory (Theory of strainless rings), reactions of
cyclopropane and cyclobutane only.
73
BP305P. PHARMACEUTICAL ORGANIC CHEMISTRY -II (Practical)
4 Hrs/week
I
Experiments involving laboratory techniques
? Recrystallization
? Steam distillation
II Determination of following oil values (including standardization of
reagents)
? Acid value
? Saponification value
? Iodine value
III Preparation of compounds
? Benzanilide/Phenyl benzoate/Acetanilide from Aniline/ Phenol
/Aniline by acylation reaction.
? 2,4,6-Tribromo aniline/Para bromo acetanilide from Aniline/
? Acetanilide by halogenation (Bromination) reaction.
? 5-Nitro salicylic acid/Meta di nitro benzene from Salicylic acid /
Nitro benzene by nitration reaction.
? Benzoic acid from Benzyl chloride by oxidation reaction.
? Benzoic acid/ Salicylic acid from alkyl benzoate/ alkyl salicylate by
hydrolysis reaction.
? 1-Phenyl azo-2-napthol from Aniline by diazotization and coupling
reactions.
? Benzil from Benzoin by oxidation reaction.
? Dibenzal acetone from Benzaldehyde by Claison Schmidt reaction
? Cinnammic acid from Benzaldehyde by Perkin reaction
? P-Iodo benzoic acid from P-amino benzoic acid
Recommended Books (Latest Editions)
1. Organic Chemistry by Morrison and Boyd
2. Organic Chemistry by I.L. Finar , Volume-I
3. Textbook of Organic Chemistry by B.S. Bahl & Arun Bahl.
4. Organic Chemistry by P.L.Soni
5. Practical Organic Chemistry by Mann and Saunders.
6. Vogel's text book of Practical Organic Chemistry
7. Advanced Practical organic chemistry by N.K.Vishnoi.
8. Introduction to Organic Laboratory techniques by Pavia, Lampman and Kriz.
74
BP302T. PHYSICAL PHARMACEUTICS-I (Theory)
45Hours
Scope: The course deals with the various physica and physicochemical properties, and
principles involved in dosage forms/formulations. Theory and practical
components of the subject help the student to get a better insight into various
areas of formulation research and development, and stability studies of
pharmaceutical dosage forms.
Objectives: Upon the completion of the course student shall be able to
1. Understand various physicochemical properties of drug molecules in the
designing the dosage forms
2. Know the principles of chemical kinetics & to use them for stability testing nad
determination of expiry date offormulations
3. Demonstrate use of physicochemical properties in the
formulation development and evaluation of dosage forms.
Course Content:
UNIT-I
10 Hours
States of Matter and properties of matter: State of matter, changes in the state of matter,
latent heats, vapour pressure, sublimation critical point, eutectic mixtures, gases, aerosols
? inhalers, relative humidity, liquid complexes, liquid crystals, glassy states, solid- crystalline,
amorphous & polymorphism.
Physicochemical properties of drug molecules: Refractive index, optical rotation,
dielectric constant, dipole moment, dissociation constant, determinations and
applications
UNIT-II
10Hours
Solubility of drugs: Solubility expressions, mechanisms of solute solvent interactions,
ideal solubility parameters, solvation & association, quantitative approach to the factors
influencing solubility of drugs, diffusion principles in biological systems. Solubility of
gas in liquids, solubility of liquids in liquids, (Binary solutions, ideal solutions)
Raoult's law, real solutions. Partially miscible liquids, Critical solution temperature and
applications. Distribution law, its limitations and applications
UNIT-III
08 Hours
Surface and interfacial phenomenon: Liquid interface, surface & interfacial tensions,
surface free energy, measurement of surface & interfacial tensions, spreading
coefficient, adsorption at liquid interfaces, surface active agents, HLB Scale,
solubilisation, detergency, adsorption at solid interface.
75
UNIT-IV
08Hours
Complexation and protein binding: Introduction, Classification of Complexation,
Applications, methods of analysis, protein binding, Complexation and drug action,
crystalline structures of complexes and thermodynamic treatment of stability constants.
UNIT-V
07 Hours
pH, buffers and Isotonic solutions: Sorensen's pH scale, pH determination
(electrometric and calorimetric), applications of buffers, buffer equation, buffer capacity,
buffers in pharmaceutical and biological systems, buffered isotonic solutions.
76
BP306P. PHYSICAL PHARMACEUTICS ? I (Practical)
4 Hrs/week
1. Determination the solubility of drug at room temperature.
2. Determination of pKa value by Half Neutralization/ Henderson Hasselbalch
equation.
3. Determination of Partition co- efficient of benzoic acid in benzene and water.
4. Determination of Partition co- efficient of Iodine in CCl4 and water
5. Determination of % composition of NaCl in a solution using phenol-water system by
CST method.
6. Determination of surface tension of given liquids by drop count and dropweight
method.
7. Determination of HLB number of a surfactant by saponification method.
8. Determination of Freundlich and Langmuir constants using activated char coal.
9. Determination of critical micellar concentration of surfactants.
10. Determination of stability constant and donor acceptor ratio of PABA-Caffeine
complex by solubility method.
11. Determination of stability constant and donor acceptor ratio of Cupric-Glycine
complex by pH titration method.
Recommended Books: (Latest Editions)
1. Physical Pharmacy by Alfred Martin
2. Experimental Pharmaceutics by Eugene, Parott.
3. Tutorial Pharmacy by Cooper and Gunn.
4. Stocklosam J. Pharmaceutical Calculations, Lea &Febiger, Philadelphia.
5. Liberman H.A, Lachman C., Pharmaceutical Dosage forms, Tablets, Volume-1 to 3,
MarcelDekkar Inc.
6. Liberman H.A, Lachman C, Pharmaceutical Dosage forms. Disperse systems,
Volume 1, 2, 3. Marcel Dekkar Inc.
7. Physical Pharmaceutics by Ramasamy C and ManavalanR.
8. Laboratory Manual of Physical Pharmaceutics, C.V.S. Subramanyam, J. Thimma
settee
9. Physical Pharmaceutics by C.V.S. Subramanyam
10. Test book of Physical Phramacy, by Gaurav Jain & Roop K. Khar
77
BP 303 T. PHARMACEUTICAL MICROBIOLOGY (Theory)
45Hours
Scope:
? Study of all categories of microorganisims especially for the production of alchol
antibiotics, vaccines, vitamins enzymes etc..
Objectives: Upon completion of the subject student shall be able to;
1. Understand methods of identification, cultivation and preservation of
various microorganisms
2. To understand the importance and implementation of sterlization in
pharmaceutical processing and industry.
3. Learn sterility testing of pharmaceutical products.
4. Carried out microbiological standardization of Pharmaceuticals.
5. Understand the cell culture technology and its applications in
pharmaceutical industries.
Course content:
Unit I
10 Hours
Introduction, history of microbiology, its branches, scope and its
importance.
Introduction to Prokaryotes and Eukaryotes
Study of ultra-structure and morphological classification of bacteria,
nutritional requirements, raw materials used for culture media and physical
parameters for growth, growth curve, isolation and preservation methods
for pure cultures, cultivation of anaerobes, quantitative measurement of
bacterial growth (total & viable count).
Study of different types of phase constrast microscopy, dark field
microscopy and electron microscopy.
Unit II
10 Hours
Identification of bacteria using staining techniques (simple, Gram's &Acid
fast staining) and biochemical tests (IMViC).
Study of principle, procedure, merits, demerits and applications of physical,
chemical gaseous,radiation and mechanical method of sterilization.
Evaluation of the efficiency of sterilization methods.
Equipments employed in large scale sterilization.
Sterility indicators.
78
Unit III
10 Hours
Study of morphology, classification, reproduction/replication and
cultivation of Fungi and Viruses.
Classification and mode of action of disinfectants
Factors influencing disinfection, antiseptics and their evaluation. For
bacteriostatic and bactericidal actions
Evaluation of bactericidal & Bacteriostatic.
Sterility testing of products (solids, liquids, ophthalmic and other sterile
products) according to IP, BP and USP.
Unit IV
08 Hours
Designing of aseptic area, laminar flow equipments; study of different
sources of contamination in an aseptic area and methods of prevention,
clean area classification.
Principles and methods of different microbiological assay. Methods for
standardization of antibiotics, vitamins and amino acids.
Assessment of a new antibiotic.
Unit V
07Hours
Types of spoilage, factors affecting the microbial spoilage of
pharmaceutical products, sources and types of microbial contaminants,
assessment of microbial contamination and spoilage.
Preservation of pharmaceutical products using antimicrobial agents,
evaluation of microbial stability of formulations.
Growth of animal cells in culture, general procedure for cell culture,
Primary, established and transformed cell cultures.
Application of cell cultures in pharmaceutical industry and research.
79
BP 307 P. PHARMACEUTICAL MICROBIOLOGY (Practical)
4 Hrs/week
1. Introduction and study of different equipments and processing, e.g., B.O.D. incubator,
laminar flow, aseptic hood, autoclave, hot air sterilizer, deep freezer, refrigerator,
microscopes used in experimental microbiology.
2. Sterilization of glassware, preparation and sterilization of media.
3. Sub culturing of bacteria and fungus. Nutrient stabs and slants preparations.
4. Staining methods- Simple, Grams staining and acid fast staining (Demonstration with
practical).
5. Isolation of pure culture of micro-organisms by multiple streak plate technique and other
techniques.
6. Microbiological assay of antibiotics by cup plate method and other methods
7. Motility determination by Hanging dropmethod.
8. Sterility testing of pharmaceuticals.
9. Bacteriological analysis of water
10. Biochemical test.
Recommended Books (Latest edition)
1. W.B. Hugo and A.D. Russel: Pharmaceutical Microbiology, Blackwell Scientific
publications, Oxford London.
2. Prescott and Dunn., Industrial Microbiology, 4th edition, CBS Publishers & Distributors,
Delhi.
3. Pelczar, Chan Kreig, Microbiology, Tata McGraw Hill edn.
4. Malcolm Harris, Balliere Tindall and Cox: Pharmaceutical Microbiology.
5. Rose: Industrial Microbiology.
6. Probisher, Hinsdill et al: Fundamentals of Microbiology, 9th ed. Japan
7. Cooper and Gunn's: Tutorial Pharmacy, CBS Publisher and Distribution.
8. Peppler: Microbial Technology.
9. I.P., B.P., U.S.P.- latest editions.
10. Ananthnarayan : Text Book of Microbiology, Orient-Longman, Chennai
11. Edward: Fundamentals of Microbiology.
12. N.K.Jain: Pharmaceutical Microbiology, Vallabh Prakashan, Delhi
13. Bergeys manual of systematic bacteriology, Williams and Wilkins- A Waverly company
80
BP 304 T. PHARMACEUTICAL ENGINEERING (Theory)
45 Hours
Scope: This course is designed to impart a fundamental knowledge on the art and science
of various unit operations used in pharmaceutical industry.
Objectives: Upon completion of the course student shall be able:
1. To know various unit operations used in Pharmaceutical industries.
2. To understand the material handling techniques.
3. To perform various processes involved in pharmaceutical manufacturing process.
4. To carry out various tests to prevent environmental pollution.
5. To appreciate and comprehend significance of plant lay out design for optimum
use of resources.
6. To appreciate the various preventive methods used for corrosion control in
Pharmaceutical industries.
Course content:
UNIT-I
10 Hours
? Flow of fluids: Types of manometers, Reynolds number and its significance,
Bernoulli's theorem and its applications, Energy losses, Orifice meter,
Venturimeter, Pitot tube and Rotometer.
? Size Reduction: Objectives, Mechanisms & Laws governing size reduction,
factors affecting size reduction, principles, construction, working, uses, merits and
demerits of Hammer mill, ball mill, fluid energy mill, Edge runner mill & end
runner mill.
? Size Separation: Objectives, applications & mechanism of size separation,
official standards of powders, sieves, size separation Principles, construction,
working, uses, merits and demerits of Sieve shaker, cyclone separator, Air
separator, Bag filter & elutriation tank.
UNIT-II
10 Hours
? Heat Transfer: Objectives, applications & Heat transfer mechanisms. Fourier's
law, Heat transfer by conduction, convection & radiation. Heat interchangers &
heat exchangers.
? Evaporation: Objectives, applications and factors influencing evaporation,
differences between evaporation and other heat process. principles, construction,
working, uses, merits and demerits of Steam jacketed kettle, horizontal tube
evaporator, climbing film evaporator, forced circulation evaporator, multiple
effect evaporator& Economy of multiple effect evaporator.
? Distillation: Basic Principles and methodology of simple distillation,flash
distillation, fractional distillation, distillation under reduced pressure, steam
distillation & molecular distillation
81
UNIT- III
08 Hours
? Drying: Objectives, applications & mechanism of drying process, measurements
& applications of Equilibrium Moisture content, rate of drying curve. principles,
construction, working, uses, merits and demerits of Tray dryer, drum dryer spray
dryer, fluidized bed dryer, vacuum dryer, freeze dryer.
? Mixing: Objectives, applications & factors affecting mixing, Difference between
solid and liquid mixing, mechanism of solid mixing, liquids mixing and
semisolids mixing. Principles, Construction, Working, uses, Merits and Demerits
of Double cone blender, twin shell blender, ribbon blender, Sigma blade mixer,
planetary mixers, Propellers, Turbines, Paddles & Silverson Emulsifier.
UNIT-IV
08 Hours
? Filtration: Objectives, applications, Theories & Factors influencing filtration,
filter aids, filter medias. Principle, Construction, Working, Uses, Merits and
demerits of plate & frame filter, filter leaf, rotary drum filter, Meta filter &
Cartridge filter, membrane filters and Seidtz filter.
? Centrifugation: Objectives, principle & applications of Centrifugation, principles,
construction, working, uses, merits and demerits of Perforated basket centrifuge,
Non-perforated basket centrifuge, semi continuous centrifuge & super centrifuge.
UNIT- V
07 Hours
? Materials of pharmaceutical plant construction, Corrosion and its prevention:
Factors affecting during materials selected for Pharmaceutical plant construction,
Theories of corrosion, types of corrosion and there prevention. Ferrous and
nonferrous metals, inorganic and organic non metals, basic of material handling
systems.
82
Recommended Books: (Latest Editions)
1. Introduction to chemical engineering ? Walter L Badger & Julius Banchero, Latest
edition.
2. Solid phase extraction, Principles, techniques and applications by Nigel J.K. Simpson-
Latest edition.
3. Unit operation of chemical engineering ? Mcabe Smith, Latest edition.
4. Pharmaceutical engineering principles and practices ? C.V.S Subrahmanyam et al., Latest
edition.
5. Remington practice of pharmacy- Martin, Latest edition.
6. Theory and practice of industrial pharmacy by Lachmann., Latest edition.
7. Physical pharmaceutics- C.V.S Subrahmanyam et al., Latest edition.
8. Cooper and Gunn's Tutorial pharmacy, S.J. Carter, Latest edition.
83
BP308P - PHARMACEUTICAL ENGINEERING (Practical)
4 Hours/week
I.
Determination of radiation constant of brass, iron, unpainted and painted glass.
II.
Steam distillation ? To calculate the efficiency of steam distillation.
III. To determine the overall heat transfer coefficient by heat exchanger.
IV. Construction of drying curves (for calcium carbonate and starch).
V.
Determination of moisture content and loss on drying.
VI.
Determination of humidity of air ? i) From wet and dry bulb temperatures ?use of
Dew point method.
VII.
Description of Construction working and application of Pharmaceutical
Machinery such as rotary tablet machine, fluidized bed coater, fluid energy mill, de
humidifier.
VIII. Size analysis by sieving ? To evaluate size distribution of tablet granulations ?
Construction of various size frequency curves including arithmetic andlogarithmic
probability plots.
IX.
Size reduction: To verify the laws of size reduction using ball mill and
determining Kicks, Rittinger's, Bond's coefficients, power requirement and critical
speed of Ball Mill.
X.
Demonstration of colloid mill, planetary mixer, fluidized bed dryer, freeze dryer
and such othermajor equipment.
XI.
Factors affecting Rate of Filtration and Evaporation (Surface area, Concentration
and Thickness/ viscosity.
XII.
To study the effect of time on the Rate of Crystallization.
XIII. To calculate the uniformity Index for given sample by using Double Cone Blender.
84
SEMESTER IV
85
BP401T. PHARMACEUTICAL ORGANIC CHEMISTRY ?III (Theory)
45 Hours
Scope: This subject imparts knowledge on stereo-chemical aspects of organic compounds
and organic reactions, important named reactions, chemistry of important hetero cyclic
compounds. It also emphasizes on medicinal and other uses of organic compounds.
Objectives: At the end of the course, the student shall be able to
1. understand the methods of preparation and properties of organic compounds
2. explain the stereo chemical aspects of organic compounds and stereo chemical
reactions
3. know the medicinal uses and other applications of organic compounds
Course Content:
Note: To emphasize on definition, types, mechanisms, examples, uses/applications
UNIT-I
10 Hours
Stereo isomerism
Optical isomerism ?
Optical activity, enantiomerism, diastereoisomerism, meso compounds
Elements of symmetry, chiral and achiral molecules
DL system of nomenclature of optical isomers, sequence rules, RS system of
nomenclature of optical isomers
Reactions of chiral molecules
Racemic modification and resolution of racemic mixture.
Asymmetric synthesis: partial and absolute
UNIT-II
10 Hours
Geometrical isomerism
Nomenclature of geometrical isomers (Cis Trans, EZ, Syn Anti systems)
Methods of determination of configuration of geometrical isomers.
Conformational isomerism in Ethane, n-Butane and Cyclohexane.
Stereo isomerism in biphenyl compounds (Atropisomerism) and conditions for optical
activity.
Stereospecific and stereoselective reactions.
86
UNIT-III
10 Hours
Heterocyclic compounds:
Nomenclature and classification
Synthesis, reactions and medicinal uses of following compounds/derivatives
Pyrrole, Furan, and Thiophene
Relative aromaticity and reactivity of Pyrrole, Furan and Thiophene.
UNIT-IV
08 Hours
Synthesis, reactions and medicinal uses of following compounds/derivatives
Pyrazole, Imidazole, Oxazole and Thiazole.
Pyridine, Quinoline, Isoquinoline, Acridine and Indole. Basicity of pyridine
Synthesis and medicinal uses of Pyrimidine, Purine, azepines and their
derivatives.
UNIT-V
07 Hours
Reactions of synthetic importance
Metal hydride reduction (NaBH4 and LiAlH4), Clemmensen reduction, Birch
reduction, Wolff Kishner reduction.
Oppenauer-oxidation and Dakin reaction.
Beckmanns rearrangement and Schmidt rearrangement.
Claisen-Schmidt condensation.
Recommended Books (Latest Editions)
1.
Organic chemistry by I.L. Finar, Volume-I & II.
2.
A text book of organic chemistry ? Arun Bahl, B.S. Bahl.
3.
Heterocyclic Chemistry by Raj K. Bansal
4.
Organic Chemistry by Morrison and Boyd
5.
Heterocyclic Chemistry by T.L. Gilchrist
87
BP402T. MEDICINAL CHEMISTRY ? I (Theory)
45 Hours
Scope: This subject is designed to impart fundamental knowledge on the structure,
chemistry and therapeutic value of drugs. The subject emphasizes on structure activity
relationships of drugs, importance of physicochemical properties and metabolism of
drugs. The syllabus also emphasizes on chemical synthesis of important drugs under each
class.
Objectives: Upon completion of the course the student shall be able to
1. understand the chemistry of drugs with respect to their pharmacological activity
2. understand the drug metabolic pathways, adverse effect and therapeutic value of
drugs
3. know the Structural Activity Relationship (SAR) of different class of drugs
4. write the chemical synthesis of some drugs
Course Content:
Study of the development of the following classes of drugs, Classification, mechanism of
action, uses of drugs mentioned in the course, Structure activity relationship of selective
class of drugs as specified in the course and synthesis of drugs superscripted (*)
UNIT- I
10 Hours
Introduction to Medicinal Chemistry
History and development of medicinal chemistry
Physicochemical properties in relation to biological action
Ionization, Solubility, Partition Coefficient, Hydrogen bonding, Protein
binding, Chelation, Bioisosterism, Optical and Geometrical isomerism.
Drug metabolism
Drug metabolism principles- Phase I and Phase II.
Factors affecting drug metabolism including stereo chemical aspects.
UNIT- II
10 Hours
Drugs acting on Autonomic Nervous System
Adrenergic Neurotransmitters:
Biosynthesis and catabolism of catecholamine.
Adrenergic receptors (Alpha & Beta) and their distribution.
Sympathomimetic agents: SAR of Sympathomimetic agents
Direct acting: Nor-epinephrine, Epinephrine, Phenylephrine*, Dopamine,
88
Methyldopa,
Clonidine,
Dobutamine,
Isoproterenol,
Terbutaline,
Salbutamol*, Bitolterol, Naphazoline, Oxymetazoline and Xylometazoline.
? Indirect acting agents: Hydroxyamphetamine, Pseudoephedrine,
Propylhexedrine.
? Agents with mixed mechanism: Ephedrine, Metaraminol.
Adrenergic Antagonists:
Alpha
adrenergic
blockers:
Tolazoline*,
Phentolamine,
Phenoxybenzamine, Prazosin, Dihydroergotamine, Methysergide.
Beta adrenergic blockers: SAR of beta blockers, Propranolol*,
Metibranolol, Atenolol, Betazolol, Bisoprolol, Esmolol, Metoprolol,
Labetolol, Carvedilol.
UNIT-III
10 Hours
Cholinergic neurotransmitters:
Biosynthesis and catabolism of acetylcholine.
Cholinergic receptors (Muscarinic & Nicotinic) and their distribution.
Parasympathomimetic agents: SAR of Parasympathomimetic agents
Direct
acting
agents:
Acetylcholine,
Carbachol*,
Bethanechol,
Methacholine, Pilocarpine.
Indirect acting/ Cholinesterase inhibitors (Reversible & Irreversible):
Physostigmine, Neostigmine*, Pyridostigmine, Edrophonium chloride,
Tacrine hydrochloride, Ambenonium chloride, Isofluorphate, Echothiophate
iodide, Parathione, Malathion.
Cholinesterase reactivator: Pralidoxime chloride.
Cholinergic Blocking agents: SAR of cholinolytic agents
Solanaceous alkaloids and analogues: Atropine sulphate, Hyoscyamine
sulphate, Scopolamine hydrobromide, Homatropine hydrobromide,
Ipratropium bromide*.
Synthetic cholinergic blocking agents: Tropicamide, Cyclopentolate
hydrochloride,
Clidinium
bromide,
Dicyclomine
hydrochloride*,
Glycopyrrolate, Methantheline bromide, Propantheline bromide, Benztropine
mesylate, Orphenadrine citrate, Biperidine hydrochloride, Procyclidine
hydrochloride*, Tridihexethyl chloride, Isopropamide iodide, Ethopropazine
hydrochloride.
89
UNIT- IV
08 Hours
Drugs acting on Central Nervous System
A. Sedatives and Hypnotics:
Benzodiazepines: SAR of Benzodiazepines, Chlordiazepoxide, Diazepam*,
Oxazepam, Chlorazepate, Lorazepam, Alprazolam, Zolpidem
Barbiturtes: SAR of barbiturates, Barbital*, Phenobarbital, Mephobarbital,
Amobarbital, Butabarbital, Pentobarbital, Secobarbital
Miscelleneous:
Amides & imides: Glutethmide.
Alcohol & their carbamate derivatives: Meprobomate, Ethchlorvynol.
Aldehyde & their derivatives: Triclofos sodium, Paraldehyde.
B. Antipsychotics
Phenothiazeines: SAR of Phenothiazeines - Promazine hydrochloride,
Chlorpromazine
hydrochloride*,
Triflupromazine,
Thioridazine
hydrochloride, Piperacetazine hydrochloride, Prochlorperazine maleate,
Trifluoperazine hydrochloride.
Ring Analogues of Phenothiazeines: Chlorprothixene, Thiothixene,
Loxapine succinate, Clozapine.
Fluro buterophenones: Haloperidol, Droperidol, Risperidone.
Beta amino ketones: Molindone hydrochloride.
Benzamides: Sulpieride.
C. Anticonvulsants: SAR of Anticonvulsants, mechanism of anticonvulsant
action
Barbiturates: Phenobarbitone, Methabarbital.
Hydantoins: Phenytoin*, Mephenytoin, Ethotoin
Oxazolidine diones: Trimethadione, Paramethadione
Succinimides: Phensuximide, Methsuximide, Ethosuximide*
Urea and monoacylureas: Phenacemide, Carbamazepine*
Benzodiazepines: Clonazepam
Miscellaneous: Primidone, Valproic acid , Gabapentin, Felbamate
90
UNIT ? V
07 Hours
Drugs acting on Central Nervous System
General anesthetics:
Inhalation
anesthetics:
Halothane*,
Methoxyflurane,
Enflurane,
Sevoflurane, Isoflurane, Desflurane.
Ultra short acting barbitutrates: Methohexital sodium*, Thiamylal sodium,
Thiopental sodium.
Dissociative anesthetics: Ketamine hydrochloride.*
Narcotic and non-narcotic analgesics
Morphine and related drugs: SAR of Morphine analogues, Morphine
sulphate, Codeine, Meperidine hydrochloride, Anilerdine hydrochloride,
Diphenoxylate hydrochloride, Loperamide hydrochloride, Fentanyl citrate*,
Methadone hydrochloride*, Propoxyphene hydrochloride, Pentazocine,
Levorphanol tartarate.
Narcotic antagonists: Nalorphine hydrochloride, Levallorphan tartarate,
Naloxone hydrochloride.
Anti-inflammatory agents: Sodium salicylate, Aspirin, Mefenamic acid*,
Meclofenamate, Indomethacin, Sulindac, Tolmetin, Zomepriac, Diclofenac,
Ketorolac, Ibuprofen*, Naproxen, Piroxicam, Phenacetin, Acetaminophen,
Antipyrine, Phenylbutazone.
91
BP406P. MEDICINAL CHEMISTRY ? I (Practical)
4 Hours/Week
I
Preparation of drugs/ intermediates
1
1,3-pyrazole
2
1,3-oxazole
3
Benzimidazole
4
Benztriazole
5
2,3- diphenyl quinoxaline
6
Benzocaine
7
Phenytoin
8
Phenothiazine
9
Barbiturate
II
Assay of drugs
1
Chlorpromazine
2
Phenobarbitone
3
Atropine
4
Ibuprofen
5
Aspirin
6
Furosemide
III
Determination of Partition coefficient for any two drugs
92
Recommended Books (Latest Editions)
1. Wilson and Giswold's Organic medicinal and Pharmaceutical Chemistry.
2. Foye's Principles of Medicinal Chemistry.
3. Burger's Medicinal Chemistry, Vol I to IV.
4. Introduction to principles of drug design- Smith and Williams.
5. Remington's Pharmaceutical Sciences.
6. Martindale's extra pharmacopoeia.
7. Organic Chemistry by I.L. Finar, Vol. II.
8. The Organic Chemistry of Drug Synthesis by Lednicer, Vol. 1-5.
9. Indian Pharmacopoeia.
10. Text book of practical organic chemistry- A.I.Vogel.
93
BP 403 T. PHYSICAL PHARMACEUTICS-II (Theory)
45Hours
Scope: The course deals with the various physica and physicochemical properties, and
principles involved in dosage forms/formulations. Theory and practical
components of the subject help the student to get a better insight into various
areas of formulation research and development, and stability studies of
pharmaceutical dosage forms.
Objectives: Upon the completion of the course student shall be able to
1. Understand various physicochemical properties of drug molecules in the
designing the dosage forms
2. Know the principles of chemical kinetics & to use them for stability testing nad
determination of expiry date offormulations
3. Demonstrate use of physicochemical properties in the
formulation development and evaluation of dosage forms.
Course Content:
UNIT-I
07 Hours
Colloidal dispersions: Classification of dispersed systems & their general characteristics,
size & shapes of colloidal particles, classification of colloids & comparative account of
their general properties. Optical, kinetic & electrical properties. Effect of electrolytes,
coacervation, peptization& protective action.
UNIT-II
10 Hours
Rheology: Newtonian systems, law of flow, kinematic viscosity, effect of temperature,
non-Newtonian systems, pseudoplastic, dilatant, plastic, thixotropy, thixotropy in
formulation, determination of viscosity, capillary, falling Sphere, rotational viscometers
Deformation of solids: Plastic and elastic deformation, Heckel equation, Stress, Strain,
Elastic Modulus
UNIT-III
10 Hours
Coarse dispersion: Suspension, interfacial properties of suspended particles, settling in
suspensions, formulation of flocculated and deflocculated suspensions. Emulsions and
theories of emulsification, microemulsion and multiple emulsions; Stability of emulsions,
preservation of emulsions, rheological properties of emulsions and emulsion formulation
by HLB method.
94
UNIT-IV
10 Hours
Micromeretics: Particle size and distribution, mean particle size, number and weight
distribution, particle number, methods for determining particle size by different methods,
counting and separation method, particle shape, specific surface, methods for determining
surface area, permeability, adsorption, derived properties of powders, porosity, packing
arrangement, densities, bulkiness & flow properties.
UNIT-V
10 Hours
Drug stability: Reaction kinetics: zero, pseudo-zero, first & second order, units of basic
rate constants, determination of reaction order. Physical and chemical factors influencing
the chemical degradation of pharmaceutical product: temperature, solvent, ionic strength,
dielectric constant, specific & general acid base catalysis, Simple numerical problems.
Stabilization of medicinal agents against common reactions like hydrolysis & oxidation.
Accelerated stability testing in expiration dating of pharmaceutical dosage forms.
Photolytic degradation and its prevention.
95
BP 407P. PHYSICAL PHARMACEUTICS- II (Practical)
3 Hrs/week
1. Determination of particle size, particle size distribution using sieving method.
2. Determination of particle size, particle size distribution using Microscopic method.
3. Determination of bulk density, true density and porosity.
4. Determine the angle of repose and influence of lubricant on angle of repose.
5. Determination of viscosity of liquid using Ostwald's viscometer.
6. Determination sedimentation volume with effect of different suspending agent.
7. Determination sedimentation volume with effect of different concentration of
single suspending agent.
8. Determination of viscosity of semisolid by using Brookfieldviscometer.
9. Determination of reaction rate constant first order.
10. Determination of reaction rate constant second order.
11. Accelerated stability studies.
Recommended Books: (Latest Editions)
1. Physical Pharmacy by Alfred Martin, Sixth edition
2. Experimental pharmaceutics by Eugene, Parott.
3. Tutorial pharmacy by Cooper and Gunn.
4. Stocklosam J. Pharmaceutical calculations, Lea & Febiger, Philadelphia.
5. Liberman H.A, Lachman C., Pharmaceutical Dosage forms, Tablets, Volume-1 to 3,
Marcel Dekkar Inc.
6. Liberman H.A, Lachman C, Pharmaceutical dosage forms. Disperse systems, volume 1,
2, 3. Marcel Dekkar Inc.
7. Physical Pharmaceutics by Ramasamy C, and Manavalan R.
96
BP 404 T. PHARMACOLOGY-I (Theory)
45 Hrs
Scope: The main purpose of the subject is to understand what drugs do to the living
organisms and how their effects can be applied to therapeutics. The subject covers the
information about the drugs like, mechanism of action, physiological and biochemical
effects (pharmacodynamics) as well as absorption, distribution, metabolism and excretion
(pharmacokinetics) along with the adverse effects, clinical uses, interactions, doses,
contraindications and routes of administration of different classes of drugs.
Objectives: Upon completion of this course the student should be able to
1. Understand the pharmacological actions of different categories of drugs
2. Explain the mechanism of drug action at organ system/sub cellular/
macromolecular levels.
3. Apply the basic pharmacological knowledge in the prevention and treatment of
various diseases.
4. Observe the effect of drugs on animals by simulated experiments
5. Appreciate correlation of pharmacology with other bio medical sciences
Course Content:
UNIT-I
08 hours
1. General Pharmacology
a. Introduction to Pharmacology- Definition, historical landmarks and scope of
pharmacology, nature and source of drugs, essential drugs concept and routes of
drug administration, Agonists, antagonists( competitive and non competitive), spare
receptors, addiction, tolerance, dependence, tachyphylaxis, idiosyncrasy, allergy.
b. Pharmacokinetics- Membrane transport, absorption, distribution, metabolism and
excretion of drugs .Enzyme induction, enzyme inhibition, kinetics of elimination
UNIT-II
12 Hours
General Pharmacology
a. Pharmacodynamics- Principles and mechanisms of drug action. Receptor theories
and classification of receptors, regulation of receptors. drug receptors interactions
signal transduction mechanisms, G-protein?coupled receptors, ion channel receptor,
transmembrane enzyme linked receptors, transmembrane JAK-STAT binding
receptor and receptors that regulate transcription factors, dose response
relationship, therapeutic index, combined effects of drugs and factors modifying
drug action.
b. Adverse drug reactions.
c. Drug interactions (pharmacokinetic and pharmacodynamic)
d. Drug discovery and clinical evaluation of new drugs -Drug discovery phase,
preclinical evaluation phase, clinical trial phase, phases of clinical trials and
pharmacovigilance.
97
UNIT-III
10 Hours
Pharmacology of drugs acting on peripheral nervous system
a. Organization and function of ANS.
b. Neurohumoral transmission,co-transmission and classification of neurotransmitters.
c. Parasympathomimetics, Parasympatholytics, Sympathomimetics, sympatholytics.
d. Neuromuscular blocking agents and skeletal muscle relaxants (peripheral).
e. Local anesthetic agents.
f. Drugs used in myasthenia gravis and glaucoma
UNIT-IV
08 Hours
Pharmacology of drugs acting on central nervous system
a. Neurohumoral transmission in the C.N.S.special emphasis on importance of various
neurotransmitters like with GABA, Glutamate, Glycine, serotonin, dopamine.
b. General anesthetics and pre-anesthetics.
c. Sedatives, hypnotics and centrally acting muscle relaxants.
d. Anti-epileptics
e. Alcohols and disulfiram
UNIT-V
07 Hours
Pharmacology of drugs acting on central nervous system
a. Psychopharmacological agents: Antipsychotics, antidepressants, anti-
anxietyagents, anti-manics and hallucinogens.
b. Drugs used in Parkinsons disease and Alzheimer's disease.
c. CNS stimulants and nootropics.
d. Opioid analgesics and antagonists
e. Drug addiction, drug abuse, tolerance and dependence.
98
BP 408 P.PHARMACOLOGY-I (Practical)
4Hrs/Week
1. Introduction to experimental pharmacology.
2. Commonly used instruments in experimental pharmacology.
3. Study of common laboratory animals.
4. Maintenance of laboratory animals as per CPCSEA guidelines.
5. Common laboratory techniques. Blood withdrawal, serum and plasma separation,
anesthetics and euthanasia used for animal studies.
6. Study of different routes of drugs administration in mice/rats.
7. Study of effect of hepatic microsomal enzyme inducers on the phenobarbitone sleeping
time in mice.
8. Effect of drugs on ciliary motility of frogoesophagus
9. Effect of drugs on rabbit eye.
10. Effects of skeletal muscle relaxants using rota-rod apparatus.
11. Effect of drugs on locomotor activity using actophotometer.
12. Anticonvulsant effect of drugs by MES and PTZ method.
13. Study of stereotype and anti-catatonic activity of drugs on rats/mice.
14. Study of anxiolytic activity of drugs usingrats/mice.
15. Study of local anesthetics by differentmethods
Note: All laboratory techniques and animal experiments are demonstrated by simulated
experiments by softwares and videos
99
Recommended Books (Latest Editions)
1. Rang H. P., Dale M. M., Ritter J. M., Flower R. J., Rang and Dale's
Pharmacology,.Churchil Livingstone Elsevier
2. Katzung B. G., Masters S. B., Trevor A. J., Basic and clinical pharmacology, Tata Mc
Graw-Hill
3. Goodman and Gilman's, The Pharmacological Basis of Therapeutics
4. Marry Anne K. K., Lloyd Yee Y., Brian K. A., Robbin L.C., Joseph G. B., Wayne A. K.,
Bradley R.W., Applied Therapeutics, The Clinical use of Drugs, The Point Lippincott
Williams & Wilkins
5. Mycek M.J, Gelnet S.B and Perper M.M. Lippincott's Illustrated Reviews-
Pharmacology.
6. K.D.Tripathi. Essentials of Medical Pharmacology, JAYPEE Brothers Medical
Publishers (P) Ltd, New Delhi.
7. Sharma H. L., Sharma K. K., Principles of Pharmacology, Paras medical publisher
8. Modern Pharmacology with clinical Applications, by Charles R.Craig& Robert,
9. Ghosh MN. Fundamentals of Experimental Pharmacology. Hilton & Company, Kolkata.
10. Kulkarni SK. Handbook of experimental pharmacology. VallabhPrakashan,
100
BP 405 T.PHARMACOGNOSY AND PHYTOCHEMISTRY I (Theory)
45 Hours
Scope: The subject involves the fundamentals of Pharmacognosy like scope, classification of
crude drugs, their identification and evaluation, phytochemicals present in them and their
medicinal properties.
Objectives: Upon completion of the course, the student shall be able
1. to know the techniques in the cultivation and production of crude drugs
2. to know the crude drugs, their uses and chemical nature
3. know the evaluation techniques for the herbal drugs
4. to carry out the microscopic and morphological evaluation of crude drugs
Course Content:
UNIT-I
10 Hours
Introduction to Pharmacognosy:
(a) Definition, history, scope and development of Pharmacognosy
(b) Sources of Drugs ? Plants, Animals, Marine & Tissue culture
(c) Organized drugs, unorganized drugs (dried latex, dried juices, dried extracts, gums and
mucilages, oleoresins and oleo- gum -resins).
Classification of drugs:
Alphabetical, morphological, taxonomical, chemical, pharmacological, chemo and sero
taxonomical classification of drugs
Quality control of Drugs of Natural Origin:
Adulteration of drugs of natural origin. Evaluation by organoleptic, microscopic, physical,
chemical and biological methods and properties.
Quantitative microscopy of crude drugs including lycopodium spore method, leafconstants,
camera lucida and diagrams of microscopic objects to scale with camera lucida.
UNIT-II
10 Hours
Cultivation, Collection, Processing and storage of drugs of natural origin:
Cultivation and Collection of drugs of natural origin
Factors influencing cultivation of medicinal plants.
Plant hormones and their applications.
Polyploidy, mutation and hybridization with reference to medicinal plants
Conservation of medicinal plants
UNIT-III
07 Hours
Plant tissue culture:
Historical development of plant tissue culture, types of cultures, Nutritional requirements,
growth and their maintenance.
Applications of plant tissue culture in pharmacognosy.
Edible vaccines
101
UNIT IV
10 Hours
Pharmacognosy in various systems of medicine:
Role of Pharmacognosy in allopathy and traditional systems of medicine namely, Ayurveda,
Unani, Siddha, Homeopathy and Chinese systems of medicine.
Introduction to secondary metabolites:
Definition, classification, properties and test for identification of Alkaloids, Glycosides,
Flavonoids, Tannins, Volatile oil and Resins.
UNIT V
08 Hours
Study of biological source, chemical nature and uses of drugs of natural origin containing
following drugs
Plant Products:
Fibers - Cotton, Jute, Hemp
Hallucinogens, Teratogens, Natural allergens
Primary metabolites:
General introduction, detailed study with respect to chemistry, sources, preparation,
evaluation, preservation, storage, therapeutic used and commercial utility as Pharmaceutical
Aids and/or Medicines for the following Primary metabolites:
Carbohydrates: Acacia, Agar, Tragacanth, Honey
Proteins and Enzymes: Gelatin, casein, proteolytic enzymes (Papain, bromelain,
serratiopeptidase, urokinase, streptokinase, pepsin).
Lipids (Waxes, fats, fixed oils) : Castor oil, Chaulmoogra oil, Wool Fat, Bees Wax
Marine Drugs: Novel medicinal agents from marine sources
102
BP408 P. PHARMACOGNOSY AND PHYTOCHEMISTRY I (Practical)
4 Hours/Week
1. Analysis of crude drugs by chemical tests: (i)Tragaccanth (ii) Acacia (iii)Agar (iv)
Gelatin (v) starch (vi) Honey (vii) Castor oil
2. Determination of stomatal number and index
3. Determination of vein islet number, vein islet termination and paliside ratio.
4. Determination of size of starch grains, calcium oxalate crystals by eye piece
micrometer
5. Determination of Fiber length and width
6. Determination of number of starch grains by Lycopodium spore method
7. Determination of Ash value
8. Determination of Extractive values of crude drugs
9. Determination of moisture content of crude drugs
10. Determination of swelling index and foaming
Recommended Books: (Latest Editions)
1. W.C.Evans, Trease and Evans Pharmacognosy, 16th edition, W.B. Sounders & Co.,
London, 2009.
2. Tyler, V.E., Brady, L.R. and Robbers, J.E., Pharmacognosy, 9th Edn., Lea and
Febiger, Philadelphia, 1988.
3. Text Book of Pharmacognosy by T.E. Wallis
4. Mohammad Ali. Pharmacognosy and Phytochemistry, CBS Publishers&
Distribution, New Delhi.
5. Text book of Pharmacognosy by C.K. Kokate, Purohit, Gokhlae (2007), 37th Edition,
Nirali Prakashan, New Delhi.
6. Herbal drug industry by R.D. Choudhary (1996), Ist Edn, Eastern Publisher, New
Delhi.
7. Essentials of Pharmacognosy, Dr.SH.Ansari, IInd edition, Birla publications, New
Delhi, 2007
8. Practical Pharmacognosy: C.K. Kokate, Purohit, Gokhlae
9. Anatomy of Crude Drugs by M.A. Iyengar
103
SEMESTER V
.
104
BP501T. MEDICINAL CHEMISTRY ? II (Theory)
45 Hours
Scope: This subject is designed to impart fundamental knowledge on the structure,
chemistry and therapeutic value of drugs. The subject emphasizes on structure activity
relationships of drugs, importance of physicochemical properties and metabolism of
drugs. The syllabus also emphasizes on chemical synthesis of important drugs under each
class.
Objectives: Upon completion of the course the student shall be able to
1. Understand the chemistry of drugs with respect to their pharmacological activity
2. Understand the drug metabolic pathways, adverse effect and therapeutic value of
drugs
3. Know the Structural Activity Relationship of different class of drugs
4. Study the chemical synthesis of selected drugs
Course Content:
Study of the development of the following classes of drugs, Classification,
mechanism of action, uses of drugs mentioned in the course, Structure activity
relationship of selective class of drugs as specified in the course and synthesis of
drugs superscripted (*)
UNIT- I
10 Hours
Antihistaminic agents: Histamine, receptors and their distribution in the
humanbody
H1?antagonists: Diphenhydramine hydrochloride*, Dimenhydrinate, Doxylamine
succinate, Clemastine fumarate, Diphenylpyraline hydrochloride, Tripelenamine
hydrochloride, Chlorcyclizine hydrochloride, Meclizine hydrochloride, Buclizine
hydrochloride,
Chlorpheniramine
maleate,
Triprolidine
hydrochloride*,
Phenindamine tartarate, Promethazine hydrochloride*, Trimeprazine tartrate,
Cyproheptadine hydrochloride, Azatidine maleate, Astemizole, Loratadine,
Cetirizine, Levocetrazine, Cromolyn sodium.
H2-antagonists: Cimetidine*, Famotidine, Ranitidine
Gastric Proton pump inhibitors: Omeprazole, Lansoprazole, Rabeprazole,
Pantoprazole, esomeprazole
Anti-neoplastic agents:
Alkylating agents: Meclorethamine*, Cyclophosphamide, Melphalan, Chlorambucil,
Busulfan, Thiotepa
Antimetabolites: Mercaptopurine*, Thioguanine, Fluorouracil, Floxuridine,
Cytarabine, Methotrexate*, Azathioprine
Antibiotics: Dactinomycin, Daunorubicin, Doxorubicin, Bleomycin
Plant products: Etoposide, Vinblastin sulphate, Vincristin sulphate
Miscellaneous: Cisplatin, Mitotane.
105
UNIT ? II
10 Hours
Anti-anginal:
Vasodilators: Amyl nitrite, Nitroglycerin*, Pentaerythritol tetranitrate, Isosorbide
dinitrite*, Dipyridamole.
Calcium channel blockers: Verapamil, Bepridil hydrochloride, Diltiazem
hydrochloride, Nifedipine, Amlodipine, Felodipine, Nicardipine, Nimodipine.
Diuretics:
Carbonic
anhydrase
inhibitors:
Acetazolamide*,
Methazolamide,
Dichlorphenamide.
Thiazides: Chlorthiazide*, Hydrochlorothiazide, Hydroflumethiazide, cyclothiazide,
Loop diuretics: Furosemide*, Bumetanide, Ethacrynic acid.
Potassium sparing Diuretics: Spironolactone, Triamterene, Amiloride.
Osmotic Diuretics: Mannitol
Anti-hypertensive Agents: Timolol, Captopril, Lisinopril, Enalapril, Benazepril
hydrochloride, Quinapril hydrochloride, Methyldopate hydrochloride,* Clonidine
hydrochloride, Guanethidine monosulphate, Guanabenz acetate, Sodium
nitroprusside, Diazoxide, Minoxidil, Reserpine, Hydralazine hydrochloride.
UNIT- III
10 Hours
Anti-arrhythmic Drugs: Quinidine sulphate, Procainamide hydrochloride,
Disopyramide phosphate*, Phenytoin sodium, Lidocaine hydrochloride,
Tocainide hydrochloride, Mexiletine hydrochloride, Lorcainide hydrochloride,
Amiodarone, Sotalol.
Anti-hyperlipidemic agents: Clofibrate, fenofibrate, gemfibrozil, Atorvastatin,
Rosuvastatin, Lovastatin, Simvastatin, Cholesteramine and Cholestipol.
Coagulant & Anticoagulants: Menadione, Acetomenadione, Warfarin*,
Anisindione, clopidogrel.
Drugs used in Congestive Heart Failure: Digoxin, Digitoxin, Nesiritide,
Bosentan, Tezosentan.
106
UNIT- IV
08 Hours
Drugs acting on Endocrine system
Nomenclature, Stereochemistry and metabolism of steroids
Sex hormones: Testosterone, Nandralone, Progestrones, Oestriol, Oestradiol,
Oestrone, Diethylstilbestrol.
Drugs for erectile dysfunction: Sildenafil, Tadalafil.
Oral contraceptives: Mifepristone, Norgestril, Levonorgestrol
Corticosteroids: Cortisone, Hydrocortisone, Prednisolone, Betamethasone,
Dexamethasone
Thyroid and antithyroid drugs: L-Thyroxine, Triiodothyronine,
L-Thyronine, Propylthiouracil, Methimazole.
UNIT ? V
07 Hours
Antidiabetic agents:
Insulin and its preparations
Sulfonyl ureas: Tolbutamide*, Chlorpropamide, Glipizide, Glimepiride,
Glibenclamide.
Biguanides: Metformin.
Thiazolidinediones: Pioglitazone, Rosiglitazone.
Meglitinides: Repaglinide, Nateglinide.
Glucosidase inhibitors: Acrabose, Voglibose.
Local Anesthetics: SAR of Local anesthetics
Benzoic Acid derivatives; Cocaine, Hexylcaine, Meprylcaine, Cyclomethycaine,
Piperocaine.
Amino Benzoic acid derivatives: Benzocaine*, Butamben, Procaine*, Butacaine,
Propoxycaine, Tetracaine, Benoxinate.
Lidocaine/Anilide derivatives: Lignocaine, Mepivacaine, Prilocaine, Etidocaine,
Bupivacaine
Miscellaneous: Phenacaine, Diperodon, Dibucaine.*
107
Recommended Books (Latest Editions)
1. Wilson and Giswold's Organic medicinal and Pharmaceutical Chemistry.
2. Foye's Principles of Medicinal Chemistry.
3. Burger's Medicinal Chemistry, Vol I to IV.
4. Introduction to principles of drug design- Smith and Williams.
5. Remington's Pharmaceutical Sciences.
6. Martindale's extra pharmacopoeia.
7. Organic Chemistry by I.L. Finar, Vol. II.
8. The Organic Chemistry of Drug Synthesis by Lednicer, Vol. 1to 5.
9. Indian Pharmacopoeia.
10. Text book of practical organic chemistry- A.I.Vogel.
108
BP 502 T. Industrial Pharmacy I (Theory)
45 Hours
Scope: Course enables the student to understand and appreciate the influence of
pharmaceutical additives and various pharmaceutical dosage forms on the performance of
the drug product.
Objectives: Upon completion of the course the student shall be able to
1. Know the various pharmaceutical dosage forms and their manufacturing
techniques.
2. Know various considerations in development of pharmaceutical dosage forms
3. Formulate solid, liquid and semisolid dosage forms and evaluate them for their
quality
Course content:
3 hours/ week
UNIT-I
07 Hours
Preformulation Studies: Introduction to preformulation, goals and objectives, study of
physicochemical characteristics of drug substances.
a. Physical properties: Physical form (crystal & amorphous), particle size, shape, flow
properties, solubility profile (pKa, pH, partition coefficient), polymorphism
b. Chemical Properties: Hydrolysis, oxidation, reduction, racemisation, polymerization
BCS classification of drugs & its significant
Application of preformulation considerations in the development of solid, liquid oral and
parenteral dosage forms and its impact on stability of dosage forms.
UNIT-II
10 Hours
Tablets:
a. Introduction, ideal characteristics of tablets, classification of tablets. Excipients,
Formulation of tablets, granulation methods, compression and processing problems.
Equipments and tablet tooling.
b. Tablet coating: Types of coating, coating materials, formulation of coating
composition, methods of coating, equipment employed and defects in coating.
c. Quality control tests: In process and finished product tests
109
UNIT-III
08 Hours
Capsules:
a. Hard gelatin capsules: Introduction, Production of hard gelatin capsule shells. size
of capsules, Filling, finishing and special techniques of formulation of hard gelatin
capsules, manufacturing defects. In process and final product quality control tests
for capsules.
b. Soft gelatin capsules: Nature of shell and capsule content, size of capsules
,importance of base adsorption and minim/gram factors, production, in process and
final product quality control tests. Packing, storage and stability testing of soft gelatin
capsules and their applications.
Pellets: Introduction, formulation requirements, pelletization process, equipments for
manufacture of pellets
UNIT-IV
10 Hours
Parenteral Products:
a. Definition, types, advantages and limitations. Preformulation factors and essential
requirements, vehicles, additives, importance of isotonicity
b. Production procedure, production facilities and controls, aseptic processing
c. Formulation of injections, sterile powders, large volume parenterals and
lyophilized products.
d. Containers and closures selection, filling and sealing of ampoules, vials and
infusion fluids. Quality control tests of parenteral products.
Ophthalmic Preparations: Introduction, formulation considerations; formulation of eye
drops, eye ointments and eye lotions; methods of preparation; labeling, containers;
evaluation of ophthalmic preparations
Liquid orals: Formulation and manufacturing consideration of syrups and elixirs
suspensions and emulsions; Filling and packaging; evaluation of liquid orals official in
pharmacopoeia
UNIT-V
10 Hours
Cosmetics: Formulation and preparation of the following cosmetic preparations: lipsticks,
shampoos, cold cream and vanishing cream, tooth pastes, hair dyes and sunscreens.
Pharmaceutical Aerosols: Definition, propellants, containers, valves, types of aerosol
systems; formulation and manufacture of aerosols; Evaluation of aerosols; Quality control
and stability studies.
Packaging Materials Science: Materials used for packaging of pharmaceutical products,
factors influencing choice of containers, legal and official requirements for containers,
stability aspects of packaging materials, quality control tests.
110
BP 506 P. Industrial PharmacyI (Practical)
4 Hours/week
1. Preformulation studies on paracetamol/asparin/or any other drug
2. Preparation and evaluation of Paracetamol tablets
3. Preparation and evaluation of Aspirin tablets
4. Coating of tablets- film coating of tables/granules
5. Preparation and evaluation of Tetracycline capsules
6. Preparation of Calcium Gluconate injection
7. Preparation of Ascorbic Acid injection
8. Qulaity control test of (as per IP) marketed tablets and capsules
9. Preparation of Eye drops/ and Eye ointments
10. Preparation of Creams (cold / vanishing cream)
11. Evaluation of Glass containers (as per IP)
Recommended Books: (Latest Editions)
1. Pharmaceutical dosage forms - Tablets, volume 1 -3 by H.A. Liberman, Leon
Lachman &J.B.Schwartz.
2. Pharmaceutical dosage form - Parenteral medication vol- 1&2 by Liberman &
Lachman.
3. Pharmaceutical dosage form disperse system VOL-1 by Liberman & Lachman.
4. Modern Pharmaceutics by Gilbert S. Banker & C.T. Rhodes, 3rd Edition.
5. Remington: The Science and Practice of Pharmacy, 20th edition Pharmaceutical
Science (RPS).
6. Theory and Practice of Industrial Pharmacy by Liberman & Lachman.
7. Pharmaceutics- The science of dosage form design by M.E.Aulton, Churchill
livingstone, Latest edition.
8. Introduction to Pharmaceutical Dosage Forms by H. C.Ansel, Lea &Febiger,
Philadelphia, 5thedition, 2005.
9. Drug stability - Principles and practice by Cartensen & C.J. Rhodes, 3rd Edition,
Marcel Dekker Series, Vol 107.
111
BP503.T. PHARMACOLOGY-II (Theory)
45 Hours
Scope: This subject is intended to impart the fundamental knowledge on various aspects
(classification, mechanism of action, therapeutic effects, clinical uses, side effects and
contraindications) of drugs acting on different systems of body and in addition,emphasis
on the basic concepts of bioassay.
Objectives: Upon completion of this course the student should be able to
1. Understand the mechanism of drug action and its relevance in the treatment of
different diseases
2. Demonstrate isolation of different organs/tissues from the laboratory animals by
simulated experiments
3. Demonstrate the various receptor actions using isolated tissue preparation
4. Appreciate correlation of pharmacology with related medical sciences
Course Content:
UNIT-I
10hours
1. Pharmacology of drugs acting on cardio vascular system
a. Introduction to hemodynamic and electrophysiology of heart.
b. Drugs used in congestive heart failure
c. Anti-hypertensive drugs.
d. Anti-anginal drugs.
e. Anti-arrhythmic drugs.
f. Anti-hyperlipidemic drugs.
UNIT-II
10hours
1. Pharmacology of drugs acting on cardio vascular system
a. Drug used in the therapy of shock.
b. Hematinics, coagulants and anticoagulants.
c. Fibrinolytics and anti-platelet drugs
d. Plasma volume expanders
2. Pharmacology of drugs acting on urinary system
a. Diuretics
b. Anti-diuretics.
UNIT-III
10hours
3. Autocoids and related drugs
a. Introduction to autacoids and classification
b. Histamine, 5-HT and their antagonists.
c. Prostaglandins, Thromboxanes and Leukotrienes.
d. Angiotensin, Bradykinin and Substance P.
e. Non-steroidal anti-inflammatory agents
f. Anti-gout drugs
g. Antirheumatic drugs
112
UNIT-IV
08hours
4. Pharmacology of drugs acting on endocrine system
a. Basic concepts in endocrine pharmacology.
b. Anterior Pituitary hormones- analogues and their inhibitors.
c. Thyroid hormones- analogues and their inhibitors.
d. Hormones regulating plasma calcium level- Parathormone, Calcitonin and
Vitamin-D.
d. Insulin, Oral Hypoglycemic agents and glucagon.
e. ACTH and corticosteroids.
UNIT-V
07hours
5. Pharmacology of drugs acting on endocrine system
a. Androgens and Anabolic steroids.
b. Estrogens, progesterone and oral contraceptives.
c. Drugs acting on the uterus.
6. Bioassay
a. Principles and applications of bioassay.
b. Types of bioassay
c. Bioassay of insulin, oxytocin, vasopressin, ACTH, d-tubocurarine, digitalis,
histamine and 5-HT.
113
BP 507 P. PHARMACOLOGY-II (Practical)
4Hrs/Week
1. Introduction to in-vitro pharmacology and physiological salt solutions.
2. Effect of drugs on isolated frog heart.
3. Effect of drugs on blood pressure and heart rate of dog.
4. Study of diuretic activity of drugs using rats/mice.
5. DRC of acetylcholine using frog rectus abdominis muscle.
6. Effect of physostigmine and atropine on DRC of acetylcholine using frogrectus
abdominis muscle and rat ileum respectively.
7. Bioassay of histamine using guinea pig ileum by matchingmethod.
8. Bioassay of oxytocin using rat uterine horn by interpolation method.
9. Bioassay of serotonin using rat fundus strip by three point bioassay.
10. Bioassay of acetylcholine using rat ileum/colon by four point bioassay.
11. Determination of PA2 value of prazosin using rat anococcygeus muscle (by
Schilds plot method).
12. Determination of PD2 value using guinea pig ileum.
13. Effect of spasmogens and spasmolytics using rabbit jejunum.
14. Anti-inflammatory activity of drugs using carrageenan induced paw-edema
model.
15. Analgesic activity of drug using central and peripheral methods
Note: All laboratory techniques and animal experiments are demonstrated by simulated
experiments by softwares and videos
Recommended Books (Latest Editions)
1. Rang H. P., Dale M. M., Ritter J. M., Flower R. J., Rang and Dale's Pharmacology,
Churchil Livingstone Elsevier
2. Katzung B. G., Masters S. B., Trevor A. J., Basic and clinical pharmacology, Tata Mc
Graw-Hill.
3. Goodman and Gilman's, The Pharmacological Basis of Therapeutics
4. Marry Anne K. K., Lloyd Yee Y., Brian K. A., Robbin L.C., Joseph G. B., Wayne A.
K., Bradley R.W., Applied Therapeutics, The Clinical use of Drugs, The Point
Lippincott Williams & Wilkins.
5. Mycek M.J, Gelnet S.B and Perper M.M. Lippincott's Illustrated Reviews-
Pharmacology.
6. K.D.Tripathi. Essentials of Medical Pharmacology, , JAYPEE Brothers Medical
Publishers (P) Ltd, New Delhi.
7. Sharma H. L., Sharma K. K., Principles of Pharmacology, Paras medical publisher
8. Modern Pharmacology with clinical Applications, by Charles R.Craig& Robert.
9. Ghosh MN. Fundamentals of Experimental Pharmacology. Hilton & Company,
Kolkata.
10. Kulkarni SK. Handbook of experimental pharmacology. Vallabh Prakashan.
114
BP504 T. PHARMACOGNOSY AND PHYTOCHEMISTRY II (Theory)
45Hours
Scope: The main purpose of subject is to impart the students the knowledge of how the
secondary metabolites are produced in the crude drugs, how to isolate and identify and
produce them industrially. Also this subject involves the study of producing the plants and
phytochemicals through plant tissue culture, drug interactions and basic principles of
traditional system of medicine
Objectives: Upon completion of the course, the student shall be able
1. to know the modern extraction techniques, characterization and identification of the
herbal drugs and phytoconstituents
2. to understand the preparation and development of herbal formulation.
3. to understand the herbal drug interactions
4. to carryout isolation and identification of phytoconstituents
Course Content:
UNIT-I
7 Hours
Metabolic pathways in higher plants and their determination
a) Brief study of basic metabolic pathways and formation of different secondary metabolites
through these pathways- Shikimic acid pathway, Acetate pathways and Amino acid pathway.
b) Study of utilization of radioactive isotopes in the investigation ofBiogenetic studies.
UNIT-II
14 Hours
General introduction, composition, chemistry & chemical classes, biosources, therapeutic
uses and commercial applications of following secondary metabolites:
Alkaloids: Vinca, Rauwolfia, Belladonna, Opium,
Phenylpropanoids and Flavonoids: Lignans, Tea, Ruta
Steroids, Cardiac Glycosides & Triterpenoids: Liquorice, Dioscorea, Digitalis
Volatile oils: Mentha, Clove, Cinnamon, Fennel, Coriander,
Tannins: Catechu, Pterocarpus
Resins: Benzoin, Guggul, Ginger, Asafoetida, Myrrh, Colophony
Glycosides: Senna, Aloes, Bitter Almond
Iridoids, Other terpenoids & Naphthaquinones: Gentian, Artemisia, taxus, carotenoids
UNIT-III
06 Hours
Isolation, Identification and Analysis of Phytoconstituents
a) Terpenoids: Menthol, Citral, Artemisin
b) Glycosides: Glycyrhetinic acid & Rutin
c) Alkaloids: Atropine, Quinine, Reserpine, Caffeine
d) Resins: Podophyllotoxin, Curcumin
UNIT-IV
10 Hours
Industrial production, estimation and utilization of the following phytoconstituents:
Forskolin, Sennoside, Artemisinin, Diosgenin, Digoxin, Atropine, Podophyllotoxin, Caffeine,
Taxol, Vincristine and Vinblastine.
UNIT V
8 Hours
Basics of Phytochemistry
Modern methods of extraction, application of latest techniques like Spectroscopy,
chromatography and electrophoresis in the isolation, purification and identification of crude
drugs.
115
BP 508 P. PHARMACOGNOSY AND PHYTOCHEMISTRY II (Practical)
4 Hours/Week
1. Morphology, histology and powder characteristics & extraction & detection of:
Cinchona, Cinnamon, Senna, Clove, Ephedra, Fennel and Coriander
2. Exercise involving isolation & detection of active principles
a. Caffeine - from tea dust.
b. Diosgenin from Dioscorea
c. Atropine from Belladonna
d. Sennosides from Senna
3. Separation of sugars by Paper chromatography
4. TLC of herbal extract
5. Distillation of volatile oils and detection of phytoconstitutents byTLC
6. Analysis of crude drugs by chemical tests: (i) Asafoetida (ii) Benzoin (iii)
Colophony (iv) Aloes (v) Myrrh
Recommended Books: (Latest Editions)
1. W.C.Evans, Trease and Evans Pharmacognosy, 16th edition, W.B. Sounders & Co.,
London, 2009.
2. Mohammad Ali. Pharmacognosy and Phytochemistry, CBS Publishers&
Distribution, New Delhi.
3. Text book of Pharmacognosy by C.K. Kokate, Purohit, Gokhlae (2007), 37th Edition,
Nirali Prakashan, New Delhi.
4. Herbal drug industry by R.D. Choudhary (1996), Ist Edn, Eastern Publisher, New
Delhi.
5. Essentials of Pharmacognosy, Dr.SH.Ansari, IInd edition, Birla publications, New
Delhi, 2007
6. Herbal Cosmetics by H.Pande, Asia Pacific Business press, Inc, New Delhi.
7. A.N. Kalia, Textbook of Industrial Pharmacognosy, CBS Publishers, New Delhi,
2005.
8. R Endress, Plant cell Biotechnology, Springer-Verlag, Berlin, 1994.
9. Pharmacognosy & Pharmacobiotechnology. James Bobbers, Marilyn KS, VE Tylor.
10. The formulation and preparation of cosmetic, fragrances and flavours.
11. Remington's Pharmaceutical sciences.
12. Text Book of Biotechnology by Vyas and Dixit.
13. Text Book of Biotechnology by R.C. Dubey.
116
BP 505 T. PHARMACEUTICAL JURISPRUDENCE (Theory)
45 Hours
Scope: This course is designed to impart basic knowledge on important
legislations related to the profession of pharmacy in India.
Objectives: Upon completion of the course, the student shall be able to understand:
1. The Pharmaceutical legislations and their implications in the development and
marketing of pharmaceuticals.
2. Various Indian pharmaceutical Acts and Laws
3. The regulatory authorities and agencies governing the manufacture and sale of
pharmaceuticals
4. The code of ethics during the pharmaceutical practice
Course Content:
UNIT-I
10 Hours
Drugs and Cosmetics Act, 1940 and its rules 1945:
Objectives, Definitions, Legal definitions of schedules to the Act and
Rules
Import of drugs ? Classes of drugs and cosmetics prohibited from import, Import under
license or permit. Offences and penalties.
Manufacture of drugs ? Prohibition of manufacture and sale of certain drugs,
Conditions for grant of license and conditions of license for manufacture of drugs,
Manufacture of drugs for test, examination and analysis, manufacture of new drug, loan
license and repacking license.
UNIT-II
10 Hours
Drugs and Cosmetics Act, 1940 and its rules 1945.
Detailed study of Schedule G, H, M, N, P,T,U, V, X, Y, Part XII B, Sch F & DMR (OA)
Sale of Drugs ? Wholesale, Retail sale and Restricted license. Offences and penalties
Labeling & Packing of drugs- General labeling requirements and specimen labels for
drugs and cosmetics, List of permitted colors. Offences and penalties.
Administration of the Act and Rules ? Drugs Technical Advisory Board, Central drugs
Laboratory, Drugs Consultative Committee, Government drug analysts, Licensing
authorities, controlling authorities, Drugs Inspectors
UNIT-III
10 Hours
? Pharmacy Act ?1948: Objectives, Definitions, Pharmacy Council of India; its constitution
and functions, Education Regulations, State and Joint state pharmacy councils; constitution
and functions, Registration of Pharmacists, Offences and Penalties.
117
? Medicinal and Toilet Preparation Act ?1955: Objectives, Definitions, Licensing,
Manufacture In bond and Outside bond, Export of alcoholic preparations,
Manufacture of Ayurvedic, Homeopathic, Patent & Proprietary Preparations.
Offences and Penalties.
? Narcotic Drugs and Psychotropic substances Act - 1985 and Rules: Objectives,
Definitions, Authorities and Officers, Constitution and Functions of narcotic &
Psychotropic Consultative Committee, National Fund for Controlling the Drug Abuse,
Prohibition, Control and Regulation, opium poppy cultivation and production of poppy
straw, manufacture, sale and export of opium, Offences and Penalties
UNIT-IV
08 Hours
? Study of Salient Features of Drugs and Magic Remedies Act and its
rules: Objectives, Definitions, Prohibition of certain advertisements, Classes of
Exempted advertisements, Offences and Penalties
? Prevention of Cruelty to animals Act-1960: Objectives, Definitions, Institutional
Animal Ethics Committee, CPCSEA guidelines for Breeding and Stocking of
Animals, Performance of Experiments, Transfer and acquisition of animals for
experiment, Records, Power to suspend or revoke registration, Offences and Penalties
? National Pharmaceutical Pricing Authority: Drugs Price Control Order (DPCO)-
2013. Objectives, Definitions, Sale prices of bulk drugs, Retail price of formulations,
Retail price and ceiling price of scheduled formulations, National List of Essential
Medicines (NLEM)
UNIT-V
07 Hours
? Pharmaceutical Legislations ? A brief review, Introduction, Study of drugs enquiry
committee, Health survey and development committee, Hathi committee and
Mudaliar committee
? Code of Pharmaceutical ethics D efinition, Pharmacist in relation to his job, trade,
medical profession and his profession, Pharmacist's oath
? Medical Termination of Pregnancy Act
? Right to Information Act
? Introduction to Intellectual Property Rights (IPR)
118
Recommended books: (Latest Edition)
1. Forensic Pharmacy by B. Suresh
2. Text book of Forensic Pharmacy by B.M. Mithal
3. Hand book of drug law-by M.L. Mehra
4. A text book of Forensic Pharmacy by N.K. Jain
5. Drugs and Cosmetics Act/Rules by Govt. of India publications.
6. Medicinal and Toilet preparations act 1955 by Govt. of India publications.
7. Narcotic drugs and psychotropic substances act by Govt. of India publications
8. Drugs and Magic Remedies act by Govt. of India publication
9. Bare Acts of the said laws published by Government. Reference books (Theory)
119
SEMESTER VI
120
BP601T. MEDICINAL CHEMISTRY ? III (Theory)
45 Hours
Scope: This subject is designed to impart fundamental knowledge on the structure,
chemistry and therapeutic value of drugs. The subject emphasis on modern techniques of
rational drug design like quantitative structure activity relationship (QSAR), Prodrug
concept, combinatorial chemistry and Computer aided drug design (CADD). The subject
also emphasizes on the chemistry, mechanism of action, metabolism, adverse effects,
Structure Activity Relationships (SAR), therapeutic uses and synthesis of important
drugs.
Objectives: Upon completion of the course student shall be able to
1. Understand the importance of drug design and different techniques of drug
design.
2. Understand the chemistry of drugs with respect to their biological activity.
3. Know the metabolism, adverse effects and therapeutic value of drugs.
4. Know the importance of SAR of drugs.
Course Content:
Study of the development of the following classes of drugs, Classification, mechanism of
action, uses of drugs mentioned in the course, Structure activity relationship of selective
class of drugs as specified in the course and synthesis of drugs superscripted by (*)
UNIT ? I
10 Hours
Antibiotics
Historical background, Nomenclature, Stereochemistry, Structure activity
relationship, Chemical degradation, classification and important products of
the following classes.
-Lactam antibiotics: Penicillin, Cepholosporins, - Lactamase inhibitors,
Monobactams
Aminoglycosides: Streptomycin, Neomycin, Kanamycin, Clindamycin
Tetracyclines: Tetracycline,Oxytetracycline, Chlortetracycline, Minocycline,
Doxycycline
UNIT ? II
10 Hours
Antibiotics
Historical background, Nomenclature, Stereochemistry, Structure activity
relationship, Chemical degradation, classification and important products of
the following classes.
121
Macrolide: Erythromycin, Clarithromycin, Azithromycin, Roxithromycin,
Tilithromycin
Miscellaneous: Chloramphenicol*.
Prodrugs: Basic concepts and application of prodrug design.
Antimalarials: Etiology of malaria.
Quinolines: SAR, Quinine sulphate, Chloroquine*, Amodiaquine,
Primaquine phosphate, Pamaquine*, Quinacrine hydrochloride, Mefloquine.
Biguanides and dihydro triazines: Cycloguanil pamoate, Proguanil.
Miscellaneous: Pyrimethamine, Artesunete, Artemether, Atovoquone.
UNIT ? III
10 Hours
Anti-tubercular Agents
Synthetic anti tubercular agents: Isoniazid*, Ethionamide, Ethambutol,
Pyrazinamide, Para aminosalicylic acid.*
Anti tubercular antibiotics: Rifampicin, Rifabutin, Cycloserine
Streptomycin, Capreomycin sulphate.
Urinary tract anti-infective agents
Quinolones and fluoroquinolines: SAR of quinolones, Nalidixic Acid,
Norfloxacin,
Enoxacin,
Ciprofloxacin*,
Levofloxacin,
Ofloxacin,
Lomefloxacin, Sparfloxacin, Gatifloxacin, Moxifloxacin
Miscellaneous: Furazolidine, Nitrofurantoin*, Methanamine.
Antiviral agents:
Amantadine hydrochloride, Rimantadine hydrochloride,
Idoxuridine
trifluoride, Acyclovir*, Gancyclovir, Zidovudine, Didanosine, Zalcitabine,
Lamivudine, Loviride, Delavirdin, Ribavirin, Saquinavir, Indinavir, Ritonavir.
UNIT ? IV
08 Hours
Antifungal agents:
Antifungal antibiotics: Amphotericin-B, Nystatin, Natamycin, Griseofulvin.
Synthetic Antifungal agents: Clotrimazole, Econazole, Butoconazole,
Oxiconazole Tioconozole, Miconazole*, Ketoconazole, Terconazole,
Itraconazole, Fluconazole, Naftifine hydrochloride, Tolnaftate*.
Anti-protozoal Agents: Metronidazole*, Tinidazole, Ornidazole, Diloxanide,
Iodoquinol, Pentamidine Isethionate, Atovaquone, Eflornithine.
Anthelmintics: Diethylcarbamazine citrate*, Thiabendazole, Mebendazole*,
Albendazole, Niclosamide, Oxamniquine, Praziquantal, Ivermectin.
122
Sulphonamides and Sulfones
Historical development, chemistry, classification and SAR of Sulfonamides:
Sulphamethizole,
Sulfisoxazole,
Sulphamethizine,
Sulfacetamide*,
Sulphapyridine, Sulfamethoxaole*, Sulphadiazine, Mefenide acetate,
Sulfasalazine.
Folate reductase inhibitors: Trimethoprim*, Cotrimoxazole.
Sulfones: Dapsone*.
UNIT ? V
07 Hours
Introduction to Drug Design
Various approaches used in drug design.
Physicochemical parameters used in quantitative structure activity
relationship (QSAR) such as partition coefficient, Hammet's electronic
parameter, Tafts steric parameter and Hansch analysis.
Pharmacophore modeling and docking techniques.
Combinatorial Chemistry: Concept and applications of of combinatorial chemistry:
solid phase and solution phase synthesis.
123
BP607P. MEDICINAL CHEMISTRY- III (Practical)
4 Hours / week
I
Preparation of drugs and intermediates
1
Sulphanilamide
2
7-Hydroxy, 4-methyl coumarin
3
Chlorobutanol
4
Triphenyl imidazole
5
Tolbutamide
6
Hexamine
II Assay of drugs
1
Isonicotinic acid hydrazide
2
Chloroquine
3
Metronidazole
4
Dapsone
5
Chlorpheniramine maleate
6
Benzyl penicillin
III Preparation of medicinally important compounds or intermediates by Microwave
irradiation technique
IV Drawing structures and reactions using chem draw?
V Determination of physicochemical properties such as logP, clogP, MR, Molecular
weight, Hydrogen bond donors and acceptors for class of drugs course content
using drug design software Drug likeliness screening (Lipinskies RO5)
124
Recommended Books (Latest Editions)
1. Wilson and Giswold's Organic medicinal and Pharmaceutical Chemistry.
2. Foye's Principles of Medicinal Chemistry.
3. Burger's Medicinal Chemistry, Vol I to IV.
4. Introduction to principles of drug design- Smith and Williams.
5. Remington's Pharmaceutical Sciences.
6. Martindale's extra pharmacopoeia.
7. Organic Chemistry by I.L. Finar, Vol. II.
8. The Organic Chemistry of Drug Synthesis by Lednicer, Vol. 1-5.
9. Indian Pharmacopoeia.
10. Text book of practical organic chemistry- A.I.Vogel.
125
BP602 T. PHARMACOLOGY-III (Theory)
45 Hours
Scope: This subject is intended to impart the fundamental knowledge on various aspects
(classification, mechanism of action, therapeutic effects, clinical uses, side effects and
contraindications) of drugs acting on respiratory and gastrointestinal system, infectious
diseases, immuno-pharmacology and in addition,emphasis on the principles of
toxicology and chronopharmacology.
Objectives: Upon completion of this course the student should be able to:
1. Understand the mechanism of drug action and its relevance in the treatment
of different infectious diseases
2. Comprehend the principles of toxicology and treatment of various poisoningsand
3. Appreciate correlation of pharmacology with related medical sciences.
Course Content:
UNIT-I
10hours
1. Pharmacology of drugs acting on Respiratory system
a. Anti -asthmatic drugs
b. Drugs used in the management of COPD
c. Expectorants and antitussives
d. Nasal decongestants
e. Respiratory stimulants
2. Pharmacology of drugs acting on the Gastrointestinal Tract
a. Antiulcer agents.
b. Drugs for constipation and diarrhoea.
c. Appetite stimulants and suppressants.
d. Digestants and carminatives.
e. Emetics and anti-emetics.
UNIT-II
10hours
Chemotherapy
f. General principles of chemotherapy.
g. Sulfonamides and cotrimoxazole.
h. Antibiotics- Penicillins, cephalosporins, chloramphenicol, macrolides, quinolones and
fluoroquinolins, tetracycline and aminoglycosides
126
UNIT-III
10 hours
Chemotherapy
a.
Antitubercular agents
b. Antileprotic agents
c.
Antifungal agents
d. Antiviral drugs
e.Anthelmintics
f. Antimalarial drugs
g. Antiamoebic agents
UNIT-IV
08 hours
Chemotherapy
a. Urinary tract infections and sexually transmitted diseases.
b. Chemotherapy of malignancy.
Immunopharmacology
a. Immunostimulants
b. Immunosuppressant
Protein drugs, monoclonal antibodies, target drugs to antigen, biosimilars
UNIT-V
07 hours
Principles of toxicology
a. Definition and basic knowledge of acute, subacute and chronic toxicity.
b. Definition and basic knowledge of genotoxicity, carcinogenicity, teratogenicity
and mutagenicity
c. General principles of treatment of poisoning
d. Clinical symptoms and management of barbiturates, morphine,
organophosphosphorus compound and lead, mercury and arsenic poisoning.
Chronopharmacology
a. Definition of rhythm and cycles.
b. Biological clock and their significance leading to chronotherapy.
127
BP 608 P. PHARMACOLOGY-III (Practical)
4Hrs/Week
1. Dose calculation in pharmacological experiments.
2. Antiallergic activity by mast cell stabilization assay
3. Study of anti-ulcer activity of a drug using pylorus ligand (SHAY) rat model
and NSAIDS induced ulcer model.
4. Study of effect of drugs on gastrointestinal motility
5. Effect of agonist and antagonists on guinea pig ileum
6. Estimation of serum biochemical parameters by using semi- autoanalyser
7. Effect of saline purgative on frog intestine
8. Insulin hypoglycemic effect in rabbit
9. Test for pyrogens ( rabbit method)
10. Determination of acute oral toxicity (LD50) of a drug from a given data
11. Determination of acute skin irritation / corrosion of a test substance
12. Determination of acute eye irritation / corrosion of a test substance
13. Calculation of pharmacokinetic parameters from a given data
14. Biostatistics methods in experimental pharmacology( student's t test,
ANOVA)
15. Biostatistics methods in experimental pharmacology (Chi square test,
Wilcoxon Signed Rank test)
*Experiments are demonstrated by simulated experiments/videos
Recommended Books (Latest Editions)
1. Rang H. P., Dale M. M., Ritter J. M., Flower R. J., Rang and Dale's Pharmacology,
Churchil Livingstone Elsevier
2. Katzung B. G., Masters S. B., Trevor A. J., Basic and clinical pharmacology, Tata Mc
Graw-Hill
3. Goodman and Gilman's, The Pharmacological Basis of Therapeutics
4. Marry Anne K. K., Lloyd Yee Y., Brian K. A., Robbin L.C., Joseph G. B., Wayne A.
K., Bradley R.W., Applied Therapeutics, The Clinical use of Drugs. The Point
Lippincott Williams & Wilkins
5. Mycek M.J, Gelnet S.B and Perper M.M. Lippincott's Illustrated Reviews-
Pharmacology
6. K.D.Tripathi. Essentials of Medical Pharmacology, JAYPEE Brothers Medical
Publishers (P) Ltd, New Delhi.
7. Sharma H. L., Sharma K. K., Principles of Pharmacology, Paras medical publisher
Modern Pharmacology with clinical Applications, by Charles R.Craig& Robert,
8. Ghosh MN. Fundamentals of Experimental Pharmacology. Hilton & Company,
Kolkata,
9. Kulkarni SK. Handbook of experimental pharmacology. VallabhPrakashan,
10. N.Udupa and P.D. Gupta, Concepts in Chronopharmacology.
128
BP 603 T. HERBAL DRUG TECHNOLOGY (Theory)
45 hours
Scope: This subject gives the student the knowledge of basic understanding of herbal drug
industry, the quality of raw material, guidelines for quality of herbal drugs, herbal cosmetics,
natural sweeteners, nutraceutical etc. The subject also emphasizes on Good Manufacturing
Practices (GMP), patenting and regulatory issues of herbal drugs
Objectives: Upon completion of this course the student should be able to:
1. understand raw material as source of herbal drugs from cultivation to herbal drug
product
2. know the WHO and ICH guidelines for evaluation of herbal drugs
3. know the herbal cosmetics, natural sweeteners, nutraceuticals
4. appreciate patenting of herbal drugs, GMP .
Course content:
UNIT-I
11 Hours
Herbs as raw materials
Definition of herb, herbal medicine, herbal medicinal product, herbal drug preparation
Source of Herbs
Selection, identification and authentication of herbal materials
Processing of herbal raw material
Biodynamic Agriculture
Good agricultural practices in cultivation of medicinal plants including Organic farming.
Pest and Pest management in medicinal plants: Biopesticides/Bioinsecticides.
Indian Systems of Medicine
a) Basic principles involved in Ayurveda, Siddha, Unani and Homeopathy
b) Preparation and standardization of Ayurvedic formulations viz Aristas and Asawas,
Ghutika, Churna, Lehya and Bhasma.
UNIT-II
7 Hours
Nutraceuticals
General aspects, Market, growth, scope and types of products available in the market. Health
benefits and role of Nutraceuticals in ailments like Diabetes, CVS diseases, Cancer, Irritable
bowel syndrome and various Gastro intestinal diseases.
Study of following herbs as health food: Alfaalfa, Chicory, Ginger, Fenugreek, Garlic,
Honey, Amla, Ginseng, Ashwagandha, Spirulina.
Herbal-Drug and Herb-Food Interactions: General introduction to interaction and
classification. Study of following drugs and their possible side effects and interactions:
Hypercium, kava-kava, Ginkobiloba, Ginseng, Garlic, Pepper & Ephedra.
129
UNIT-III
10 Hours
Herbal Cosmetics
Sources and description of raw materials of herbal origin used via, fixed oils, waxes, gums
colours, perfumes, protective agents, bleaching agents, antioxidants in products such as skin
care, hair care and oral hygiene products.
Herbal excipients:
Herbal Excipients ? Significance of substances of natural origin as excipients ? colorants,
sweeteners, binders, diluents, viscosity builders, disintegrants, flavors & perfumes.
Herbal formulations:
Conventional herbal formulations like syrups, mixtures and tablets and Novel dosage forms
like phytosomes.
UNIT- IV
10 Hours
Evaluation of Drugs WHO & ICH guidelines for the assessment of herbal drugs Stability
testing of herbal drugs.
Patenting and Regulatory requirements of natural products:
a) Definition of the terms: Patent, IPR, Farmers right, Breeder's right, Bioprospecting and
Biopiracy
b) Patenting aspects of Traditional Knowledge and Natural Products. Case study of Curcuma
& Neem.
Regulatory Issues - Regulations in India (ASU DTAB, ASU DCC), Regulation of
manufacture of ASU drugs - Schedule Z of Drugs & Cosmetics Act for ASU drugs.
UNIT-V
07 Hours
General Introduction to Herbal Industry
Herbal drugs industry: Present scope and future prospects.
A brief account of plant based industries and institutions involved in work on medicinal and
aromatic plants in India.
Schedule T ? Good Manufacturing Practice of Indian systems of medicine
Components of GMP (Schedule ? T) and its objectives
Infrastructural requirements, working space, storage area, machinery and equipments,
standard operating procedures, health and hygiene, documentation and records.
130
BP 609 P. HERBAL DRUG TECHNOLOGY (Practical)
4 hours/ week
1. To perform preliminary phytochemical screening of crude drugs.
2. Determination of the alcohol content of Asava and Arista
3. Evaluation of excipients of natural origin
4. Incorporation of prepared and standardized extract in cosmetic formulations like
creams, lotions and shampoos and their evaluation.
5. Incorporation of prepared and standardized extract in formulations like syrups,
mixtures and tablets and their evaluation as per Pharmacopoeial requirements.
6. Monograph analysis of herbal drugs from recent Pharmacopoeias
7. Determination of Aldehyde content
8. Determination of Phenol content
9. Determination of total alkaloids
Recommended Books: (Latest Editions)
1. Textbook of Pharmacognosy by Trease & Evans.
2. Textbook of Pharmacognosy by Tyler, Brady & Robber.
3. Pharmacognosy by Kokate, Purohit and Gokhale
4. Essential of Pharmacognosy by Dr.S.H.Ansari
5. Pharmacognosy & Phytochemistry by V.D.Rangari
6. Pharmacopoeal standards for Ayurvedic Formulation (Council of Research in
Indian Medicine & Homeopathy)
7. Mukherjee, P.W. Quality Control of Herbal Drugs: An Approach to Evaluation of
Botanicals. Business Horizons Publishers, New Delhi, India, 2002.
131
BP 604 T. BIOPHARMACEUTICS AND PHARMACOKINETICS (Theory)
45 Hours
Scope: This subject is designed to impart knowledge and skills of Biopharmaceutics
and pharmacokinetics and their applications in pharmaceutical development, design
of dose and dosage regimen and in solving the problems arised therein.
Objectives: Upon completion of the course student shall be able to:
1. Understand the basic concepts in biopharmaceutics and pharmacokinetics and
their significance.
2. Use of plasma drug concentration-time data to calculate the pharmacokinetic
parameters to describe the kinetics of drug absorption, distribution,
metabolism, excretion, elimination.
3. To understand the concepts of bioavailability and bioequivalence of drug
products and their significance.
4. Understand various pharmacokinetic parameters, their significance &
applications.
Course Content:
UNIT-I
10 Hours
Introduction to Biopharmaceutics
Absorption; Mechanisms of drug absorption through GIT, factors influencing drug
absorption though GIT, absorption of drug from Non per oral extra-vascular
routes, Distribution Tissue permeability of drugs, binding of drugs, apparent, volume
of drug distribution, plasma and tissue protein binding of drugs, factors affecting
protein-drug binding. Kinetics of protein binding, Clinical significance of protein
binding of drugs
UNIT- II
10 Hours
Elimination: Drug metabolism and basic understanding metabolic
pathways renal excretion of drugs, factors affecting renal excretion of
drugs, renal clearance, Non renal routes of drug excretion of drugs
Bioavailability and Bioequivalence: Definition and Objectives of bioavailability,
absolute and relative bioavailability, measurement of bioavailability, in-vitro drug
dissolution models, in-vitro-in-vivo correlations, bioequivalence studies, methods to
enhance the dissolution rates and bioavailability of poorly soluble drugs.
132
UNIT- III
10 Hours
Pharmacokinetics: Definition and introduction to Pharmacokinetics, Compartment
models, Non compartment models, physiological models, One compartment open
model. (a). Intravenous Injection (Bolus) (b). Intravenous infusion and (c) Extra
vascular administrations. Pharmacokinetics parameters - KE ,t1/2,Vd,AUC,Ka, Clt
and CLR- definitions methods of eliminations, understanding of their significance and
application
UNIT- IV
08 Hours
Multicompartment models: Two compartment open model. IV bolus, Kinetics of
multiple dosing, steady state drug levels, calculation of loading and mainetnance doses and
their significance in clinical settings.
UNIT- V
07 Hours
Nonlinear Pharmacokinetics:
a. Introduction,
b. Factors causing Non-linearity.
c. Michaelis-menton method of estimating parameters, Explanation with example
of drugs.
Recommended Books: (Latest Editions)
1. Biopharmaceutics and Clinical Pharmacokinetics by, Milo Gibaldi.
2. Biopharmaceutics and Pharmacokinetics; By Robert F Notari
3. Applied biopharmaceutics and pharmacokinetics, Leon Shargel and Andrew
B.C.YU 4th edition,Prentice-Hall Inernational edition.USA
4. Bio pharmaceutics and Pharmacokinetics-A Treatise, By D. M. Brahmankar and
Sunil B.Jaiswal,Vallabh Prakashan Pitampura, Delhi
5. Pharmacokinetics: By Milo Glbaldi Donald, R. Mercel Dekker Inc.
6. Hand Book of Clinical Pharmacokinetics, By Milo Gibaldi and Laurie Prescott
by ADIS Health Science Press.
7. Biopharmaceutics; By Swarbrick
8. Clinical Pharmacokinetics, Concepts and Applications: By Malcolm Rowland
and Thomas, N. Tozen, Lea and Febrger, Philadelphia, 1995.
9. Dissolution, Bioavailability and Bioequivalence, By Abdou H.M, Mack,
Publishing Company, Pennsylvania 1989.
10. Biopharmaceutics and Clinical Pharmacokinetics-An introduction 4th edition
Revised and expanded by Rebort F Notari Marcel Dekker Inn, New York and
Basel, 1987.
11. Remington's Pharmaceutical Sciences, By Mack Publishing Company,
Pennsylvnia
133
BP 605 T. PHARMACEUTICAL BIOTECHNOLOGY (Theory)
45 Hours
Scope:
? Biotechnology has a long promise to revolutionize the biological sciences and
technology.
? Scientific application of biotechnology in the field of genetic engineering,
medicine and fermentation technology makes the subject interesting.
? Biotechnology is leading to new biological revolutions in diagnosis, prevention
and cure of diseases, new and cheaper pharmaceutical drugs.
? Biotechnology has already produced transgenic crops and animals and the future
promises lot more.
? It is basically a research-based subject.
Objectives: Upon completion of the subject student shall be able to;
1. Understanding the importance of Immobilized enzymes in Pharmaceutical
Industries
2. Genetic engineering applications in relation to production of pharmaceuticals
3. Importance of Monoclonal antibodies in Industries
4. Appreciate the use of microorganisms in fermentation technology
Unit I
10 Hours
a) Brief introduction to Biotechnology with reference to Pharmaceutical Sciences.
b) Enzyme Biotechnology- Methods of enzyme immobilization and applications.
c) Biosensors- Working and applications of biosensors in Pharmaceutical Industries.
d) Brief introduction to Protein Engineering.
e) Use of microbes in industry. Production of Enzymes- General consideration -
Amylase, Catalase, Peroxidase, Lipase, Protease, Penicillinase.
f) Basic principles of genetic engineering.
Unit II
10 Hours
a) Study of cloning vectors, restriction endonucleases and DNA ligase.
b) Recombinant DNA technology. Application of genetic engineering in medicine.
c) Application of r DNA technology and genetic engineering in the production of:
i) Interferon ii) Vaccines- hepatitis- B iii) Hormones-Insulin.
d) Brief introduction to PCR
134
Unit III
10 Hours
Types of immunity- humoral immunity, cellular immunity
a) Structure of Immunoglobulins
b) Structure and Function of MHC
c) Hypersensitivity reactions, Immune stimulation and Immune suppressions.
d) General method of the preparation of bacterial vaccines, toxoids, viral vaccine,
antitoxins, serum-immune blood derivatives and other products relative to immunity.
e) Storage conditions and stability of official vaccines
f) Hybridoma technology- Production, Purification and Applications
Unit IV
08Hours
a)
Immuno blotting techniques- ELISA, Western blotting, Southern blotting.
b)
Genetic organization of Eukaryotes and Prokaryotes
c)
Microbial genetics including transformation, transduction, conjugation, plasmids and
transposons.
d)
Introduction to Microbial biotransformation and applications.
e)
Mutation: Types of mutation/mutants.
Unit V
07 Hours
a)
Fermentation methods and general requirements, study of media, equipments,
sterilization methods, aeration process, stirring.
b)
Large scale production fermenter design and its various controls.
c)
Study of the production of - penicillins, citric acid, Vitamin B12, Glutamic acid,
Griseofulvin,
d)
Blood Products: Collection, Processing and Storage of whole human blood, dried
human plasma, plasma Substituties.
135
Recommended Books (Latest edition):
1. B.R. Glick and J.J. Pasternak: Molecular Biotechnology: Principles and Applications
of RecombinantDNA: ASM Press Washington D.C.
2. RA Goldshy et. al., : Kuby Immunology.
3. J.W. Goding: Monoclonal Antibodies.
4. J.M. Walker and E.B. Gingold: Molecular Biology and Biotechnology by Royal
Society of Chemistry.
5. Zaborsky: Immobilized Enzymes, CRC Press, Degraland, Ohio.
6. S.B. Primrose: Molecular Biotechnology (Second Edition) Blackwell Scientific
Publication.
7. Stanbury F., P., Whitakar A., and Hall J., S., Principles of fermentation technology,
2nd edition, Aditya books Ltd., New Delhi
136
BP606 T PHARMACEUTICAL QUALITY ASSURANCE (Theory)
45 Hours
Scope: This course deals with the various aspects of quality control and quality
assurance aspects of pharmaceutical industries. It deals with the important aspects like
cGMP, QC tests, documentation, quality certifications and regulatory affairs.
Objectives: Upon completion of the course student shall be able to:
? Understand the cGMP aspects in a pharmaceutical industry
? Appreciate the importance of documentation
? Understand the scope of quality certifications applicable to
pharmaceutical industries
? Understand the responsibilities of QA & QC departments
Course content:
UNIT ? I
10 Hours
Quality Assurance and Quality Management concepts: Definition and concept of Quality
control, Quality assurance and GMP
Total Quality Management (TQM): Definition, elements, philosophies
ICH Guidelines: purpose, participants, process of harmonization, Brief overview of QSEM,
with special emphasis on Q-series guidelines, ICH stability testing guidelines
Quality by design (QbD): Definition, overview, elements of QbD program, tools
ISO 9000 & ISO14000: Overview, Benefits, Elements, steps for registration
NABL accreditation: Principles and procedures
UNIT - II
10 Hours
Organization and personnel: Personnel responsibilities, training, hygiene and personal records.
Premises: Design, construction and plant layout, maintenance, sanitation, environmental
control, utilities and maintenance of sterile areas, control of contamination.
Equipments and raw materials: Equipment selection, purchase specifications, maintenance,
purchase specifications and maintenance of stores for raw materials.
UNIT ? III
10 Hours
Quality Control: Quality control test for containers, rubber closures and secondary packing
materials.
Good Laboratory Practices: General Provisions, Organization and Personnel, Facilities,
Equipment, Testing Facilities Operation, Test and Control Articles, Protocol for Conduct of a
Nonclinical Laboratory Study, Records and Reports, Disqualification of Testing Facilities
137
UNIT ? IV
08 Hours
Complaints: Complaints and evaluation of complaints, Handling of return good, recalling and
waste disposal.
Document maintenance in pharmaceutical industry: Batch Formula Record, Master Formula
Record, SOP, Quality audit, Quality Review and Quality documentation, Reports and
documents, distribution records.
UNIT ? V
07 Hours
Calibration and Validation: Introduction, definition and general principles of calibration,
qualification and validation, importance and scope of validation, types of validation, validation
master plan. Calibration of pH meter, Qualification of UV-Visible spectrophotometer, General
principles of Analytical method Validation.
Warehousing: Good warehousing practice, materials management
Recommended Books: (Latest Edition)
1. Quality Assurance Guide by organization of Pharmaceutical Products of India.
2. Good Laboratory Practice Regulations, 2nd Edition, Sandy Weinberg Vol. 69.
3. Quality Assurance of Pharmaceuticals- A compendium of Guide lines and Related
materials Vol I WHO Publications.
4. A guide to Total Quality Management- Kushik Maitra and Sedhan K Ghosh
5. How to Practice GMP's ? P P Sharma.
6. ISO 9000 and Total Quality Management ? Sadhank G Ghosh
7. The International Pharmacopoeia ? Vol I, II, III, IV- General Methods of Analysis
and Quality specification for Pharmaceutical Substances, Excipients and Dosage
forms
8. Good laboratory Practices ? Marcel Deckker Series
9. ICH guidelines, ISO 9000 and 14000 guidelines
138
SEMESTER VII
139
BP701T. INSTRUMENTAL METHODS OF ANALYSIS (Theory)
45 Hours
Scope: This subject deals with the application of instrumental methods in qualitative and
quantitative analysis of drugs. This subject is designed to impart a fundamental
knowledge on the principles and instrumentation of spectroscopic and chromatographic
technique. This also emphasizes on theoretical and practical knowledge on modern
analytical instruments that are used for drug testing.
Objectives: Upon completion of the course the student shall be able to
1. Understand the interaction of matter with electromagnetic radiations and its
applications in drug analysis
2. Understand the chromatographic separation and analysis of drugs.
3. Perform quantitative & qualitative analysis of drugs using various analytical
instruments.
Course Content:
UNIT ?I
10 Hours
UV Visible spectroscopy
Electronic transitions, chromophores, auxochromes, spectral shifts, solvent effect on
absorption spectra, Beer and Lambert's law, Derivation and deviations.
Instrumentation - Sources of radiation, wavelength selectors, sample cells, detectors-
Photo tube, Photomultiplier tube, Photo voltaic cell, Silicon Photodiode.
Applications - Spectrophotometric titrations, Single component and multi component
analysis
Fluorimetry
Theory, Concepts of singlet, doublet and triplet electronic states, internal and external
conversions, factors affecting fluorescence, quenching, instrumentation and applications
UNIT ?II
10 Hours
IR spectroscopy
Introduction, fundamental modes of vibrations in poly atomic molecules, sample handling,
factors affecting vibrations
Instrumentation - Sources of radiation, wavelength selectors, detectors - Golay cell,
Bolometer, Thermocouple, Thermister, Pyroelectric detector and applications
Flame Photometry-Principle, interferences, instrumentation and applications
140
Atomic absorption spectroscopy- Principle, interferences, instrumentation and
applications
Nepheloturbidometry- Principle, instrumentation and applications
Basic principles of NMR, Mass spectroscopy
UNIT ?III
10 Hours
Introduction to chromatography
Adsorption and partition column chromatography-Methodology, advantages,
disadvantages and applications.
Thin layer chromatography- Introduction, Principle, Methodology, Rf values,
advantages, disadvantages and applications.
Paper
chromatography - Introduction,
methodology, development techniques,
advantages, disadvantages and applications
Electrophoresis? Introduction, factors affecting electrophoretic mobility, Techniques of
paper, gel, capillary electrophoresis, applications
UNIT ?IV
08 Hours
Gas chromatography - Introduction, theory,instrumentation, derivatization,
temperature programming, advantages, disadvantages and applications
High performance liquid chromatography (HPLC) - Introduction, theory,
instrumentation, advantages and applications.
UNIT ?V
07 Hours
Ion exchange chromatography- Introduction, classification, ion exchange resins,
properties, mechanism of ion exchange process, factors affecting ion exchange,
methodology and applications
Gel chromatography- Introduction, theory, instrumentation and applications
Affinity chromatography- Introduction, theory, instrumentation and applications
141
BP705P. INSTRUMENTAL METHODS OF ANALYSIS (Practical)
4 Hours/Week
1
Determination of absorption maxima and effect of solvents on absorption
maxima of organic compounds
2
Estimation of dextrose by colorimetry
3
Estimation of sulfanilamide by colorimetry
4
Simultaneous estimation of ibuprofen and paracetamol by UV spectroscopy
5
Assay of paracetamol by UV- Spectrophotometry
6
Estimation of quinine sulfate by fluorimetry
7
Study of quenching of fluorescence
8
Determination of sodium by flame photometry
9
Determination of potassium by flame photometry
10
Determination of chlorides and sulphates by nephelo turbidometry
11
Separation of amino acids by paper chromatography
12
Separation of sugars by thin layer chromatography
13
Separation of plant pigments by column chromatography
14
Demonstration experiment on HPLC
15
Demonstration experiment on Gas Chromatography
Recommended Books (Latest Editions)
1. Instrumental Methods of Chemical Analysis by B.K Sharma
2. Organic spectroscopy by Y.R Sharma
3. Text book of Pharmaceutical Analysis by Kenneth A. Connors
4. Vogel's Text book of Quantitative Chemical Analysis by A.I. Vogel
5. Practical Pharmaceutical Chemistry by A.H. Beckett and J.B. Stenlake
6. Organic Chemistry by I. L. Finar
7. Organic spectroscopy by William Kemp
8. Quantitative Analysis of Drugs by D. C. Garrett
9. Quantitative Analysis of Drugs in Pharmaceutical Formulations by P. D. Sethi
10. Spectrophotometric identification of Organic Compounds by Silverstein
142
BP 702 T. INDUSTRIAL PHARMACY-II (Theory)
45 Hours
Scope: This course is designed to impart fundamental knowledge on pharmaceutical
product development and translation from laboratory to market
Objectives: Upon completion of the course, the student shall be able to:
1. Know the process of pilot plant and scale up of pharmaceutical dosage forms
2. Understand the process of technology transfer from lab scale to commercial batch
3. Know different Laws and Acts that regulate pharmaceutical industry
4. Understand the approval process and regulatory requirements for drug products
Course Content:
UNIT-I
10 Hours
Pilot plant scale up techniques: General considerations - including significance of
personnel requirements, space requirements, raw materials, Pilot plant scale up
considerations for solids, liquid orals, semi solids and relevant documentation, SUPAC
guidelines, Introduction to platform technology
UNIT-II
10 Hours
Technology development and transfer: WHO guidelines for Technology Transfer(TT):
Terminology, Technology transfer protocol, Quality risk management, Transfer from R
& D to production (Process, packaging and cleaning), Granularity of TT Process (API,
excipients, finished products, packaging materials) Documentation, Premises and
equipments, qualification and validation, quality control, analytical method transfer,
Approved regulatory bodies and agencies, Commercialization - practical aspects and
problems (case studies), TT agencies in India - APCTD, NRDC, TIFAC, BCIL, TBSE /
SIDBI; TT related documentation - confidentiality agreement, licensing, MoUs,
legal issues
UNIT-III
10 Hours
Regulatory affairs: Introduction, Historical overview of Regulatory Affairs, Regulatory
authorities, Role of Regulatory affairs department, Responsibility of Regulatory Affairs
Professionals
Regulatory requirements for drug approval: Drug Development Teams, Non-Clinical
Drug Development, Pharmacology, Drug Metabolism and Toxicology, General
considerations of Investigational New Drug (IND) Application, Investigator's Brochure
(IB) and New Drug Application (NDA), Clinical research / BE studies, Clinical Research
Protocols, Biostatistics in Pharmaceutical Product Development, Data Presentation for
FDA Submissions, Management of Clinical Studies.
143
UNIT-IV
08 Hours
Quality management systems: Quality management & Certifications: Concept of
Quality, Total Quality Management, Quality by Design (QbD), Six Sigma concept, Out
of Specifications (OOS), Change control, Introduction to ISO 9000 series of quality
systems standards, ISO 14000, NABL, GLP.
UNIT-V
07 Hours
Indian Regulatory Requirements: Central Drug Standard Control Organization
(CDSCO) and State Licensing Authority: Organization, Responsibilities, Certificate of
Pharmaceutical Product (COPP), Regulatory requirements and approval procedures for
New Drugs.
Recommended Books: (Latest Editions)
1. Regulatory Affairs from Wikipedia, the free encyclopedia modified on 7th April available
at http,//en.wikipedia.org/wiki/Regulatory_ Affairs.
2. International Regulatory Affairs Updates, 2005. available at
http://www.iraup.com/about.php
3. Douglas J Pisano and David S. Mantus. Text book of FDA Regulatory Affairs A Guide
for Prescription Drugs, Medical Devices, and Biologics' Second Edition.
4. Regulatory Affairs brought bylearning plus, inc. available at
http.//www.cgmp.com/ra.htm.
144
BP 703T. PHARMACY PRACTICE (Theory)
45 Hours
Scope: In the changing scenario of pharmacy practice in India, for successful practice of
Hospital Pharmacy, the students are required to learn various skills like drug distribution,
drug information, and therapeutic drug monitoring for improved patient care. In
community pharmacy, students will be learning various skills such as dispensing of
drugs, responding to minor ailments by providing suitable safe medication, patient
counselling for improved patient care in the community set up.
Objectives: Upon completion of the course, the student shall be able to
1. Know various drug distribution methods in a hospital
2. Appreciate the pharmacy stores management and inventory control
3. Monitor drug therapy of patient through medication chart review and clinical
review
4. Obtain medication history interview and counsel the patients
5. Identify drug related problems
6. Detect and assess adverse drug reactions
7. Interpret selected laboratory results (as monitoring parameters in therapeutics) of
specific disease states
8. Know pharmaceutical care services
9. Do patient counseling in community pharmacy;
10. Appreciate the concept of Rational drug therapy.
Unit I:
10 Hours
a) Hospital and it's organization
Definition, Classification of hospital- Primary, Secondary and Tertiary hospitals,
Classification based on clinical and non- clinical basis, Organization Structure of a
Hospital, and Medical staffs involved in the hospital and their functions.
b) Hospital pharmacy and its organization
Definition, functions of hospital pharmacy, Organization structure, Location, Layout
and staff requirements, and Responsibilities and functions of hospital pharmacists.
c) Adverse drug reaction
Classifications - Excessive pharmacological effects, secondary pharmacological
effects, idiosyncrasy, allergic drug reactions, genetically determined toxicity, toxicity
following sudden withdrawal of drugs, Drug interaction- beneficial interactions,
adverse interactions, and pharmacokinetic drug interactions, Methods for detecting drug
interactions, spontaneous case reports and record linkage studies, and Adverse drug
reaction reporting and management.
d) Community Pharmacy
Organization and structure of retail and wholesale drug store, types and design, Legal
requirements for establishment and maintenance of a drug store, Dispensing of
proprietary products, maintenance of records of retail and wholesale drug store.
145
Unit II:
10 Hours
a) Drug distribution system in a hospital
Dispensing of drugs to inpatients, types of drug distribution systems, charging policy
and labelling, Dispensing of drugs to ambulatory patients, and Dispensing of
controlled drugs.
b) Hospital formulary
Definition, contents of hospital formulary, Differentiation of hospital formulary and
Drug list, preparation and revision, and addition and deletion of drug from hospital
formulary.
c) Therapeutic drug monitoring
Need for Therapeutic Drug Monitoring, Factors to be considered during the
Therapeutic Drug Monitoring, and Indian scenario for Therapeutic Drug Monitoring.
d) Medication adherence
Causes of medication non-adherence, pharmacist role in the medication adherence,
and monitoring of patient medication adherence.
e) Patient medication history interview
Need for the patient medication history interview, medication interview forms.
f) Community pharmacy management
Financial, materials, staff, and infrastructure requirements.
Unit III:
10 Hours
a) Pharmacy and therapeutic committee
Organization, functions, Policies of the pharmacy and therapeutic committee in
including drugs into formulary, inpatient and outpatient prescription, automatic stop
order, and emergency drug list preparation.
b) Drug information services
Drug and Poison information centre, Sources of drug information, Computerised
services, and storage and retrieval of information.
c) Patient patient counseling
Definition of patient counseling; steps involved in patient counseling, and Special
cases that require the pharmacist
d) Education and training program in the hospital
Role of pharmacist in the education and training program, Internal and external
training program, Services to the nursing homes/clinics, Code of ethics for
community pharmacy, and Role of pharmacist in the interdepartmental
communication and community health education.
e) Prescribed medication order and communication skills
Prescribed medication order- interpretation and legal requirements, and
Communication skills- communication with prescribers and patients.
146
Unit IV
8 Hours
a) Budget preparation and implementation
Budget preparation and implementation
b) Clinical Pharmacy
Introduction to Clinical Pharmacy, Concept of clinical pharmacy, functions and
responsibilities of clinical pharmacist, Drug therapy monitoring - medication chart
review, clinical review, pharmacist intervention, Ward round participation, Medication
history and Pharmaceutical care.
Dosing pattern and drug therapy based on Pharmacokinetic & disease pattern.
c) Over the counter (OTC) sales
Introduction and sale of over the counter, and Rational use of common over the
counter medications.
Unit V
7 Hours
a) Drug store management and inventory control
Organisation of drug store, types of materials stocked and storage conditions, Purchase
and inventory control: principles, purchase procedure, purchase order, procurement
and stocking, Economic order quantity, Reorder quantity level, and Methods used for
the analysis of the drug expenditure
b) Investigational use of drugs
Description, principles involved, classification, control, identification, role of hospital
pharmacist, advisory committee.
c) Interpretation of Clinical Laboratory Tests
Blood chemistry, hematology, and urinalysis
Recommended Books (Latest Edition):
1. Merchant S.H. and Dr. J.S.Quadry. A textbook of hospital pharmacy, 4th ed.
Ahmadabad: B.S. Shah Prakakshan; 2001.
2. Parthasarathi G, Karin Nyfort-Hansen, Milap C Nahata. A textbook of Clinical
Pharmacy Practice- essential concepts and skills, 1st ed. Chennai: Orient
Longman Private Limited; 2004.
3. William E. Hassan. Hospital pharmacy, 5th ed. Philadelphia: Lea & Febiger;
1986.
4. Tipnis Bajaj. Hospital Pharmacy, 1st ed. Maharashtra: Career Publications; 2008.
5. Scott LT. Basic skills in interpreting laboratory data, 4thed. American Society of
Health System Pharmacists Inc; 2009.
6. Parmar N.S. Health Education and Community Pharmacy, 18th ed. India: CBS
Publishers & Distributers; 2008.
Journals:
1. Therapeutic drug monitoring. ISSN: 0163-4356
2. Journal of pharmacy practice. ISSN : 0974-8326
3. American journal of health system pharmacy. ISSN: 1535-2900 (online)
4. Pharmacy times (Monthly magazine)
147
BP 704T: NOVEL DRUG DELIVERY SYSTEMS (Theory)
45 Hours
Scope: This subject is designed to impart basic knowledge on the area of novel drug
delivery systems.
Objectives: Upon completion of the course student shall be able
1. To understand various approaches for development of novel drug delivery systems.
2. To understand the criteria for selection of drugs and polymers for the development of
Novel drug delivery systems, their formulation and evaluation
Course content:
Unit-I
10 Hours
Controlled drug delivery systems: Introduction, terminology/definitions and rationale,
advantages, disadvantages, selection of drug candidates.Approaches to design controlled
release formulations based on diffusion, dissolution and ion exchange principles.
Physicochemical and biological properties of drugs relevant to controlled release
formulations
Polymers: Introduction, classification, properties, advantages and application of polymers
in formulation of controlled release drug delivery systems.
Unit-II
10 Hours
Microencapsulation: Definition, advantages and disadvantages, microspheres
/microcapsules, microparticles, methods of microencapsulation, applications
Mucosal Drug Delivery system: Introduction, Principles of bioadhesion / mucoadhesion,
concepts, advantages and disadvantages, transmucosal permeability and formulation
considerations of buccal delivery systems
Implantable Drug Delivery Systems:Introduction, advantages and disadvantages,
concept of implantsand osmotic pump
Unit-III
10 Hours
Transdermal Drug Delivery Systems: Introduction, Permeation through skin, factors
affecting permeation, permeation enhancers, basic components of TDDS, formulation
approaches
Gastroretentive drug delivery systems: Introduction, advantages, disadvantages,
approaches for GRDDS ? Floating, high density systems, inflatable and gastroadhesive
systems and their applications
Nasopulmonary drug delivery system: Introduction to Nasal and Pulmonary routes of
drug delivery, Formulation of Inhalers (dry powder and metered dose), nasal sprays,
nebulizers
Unit-IV
08 Hours
Targeted drug Delivery: Concepts and approaches advantages and disadvantages,
introduction to liposomes, niosomes, nanoparticles, monoclonal antibodies and their
applications
148
Unit-V
07 Hours
Ocular Drug Delivery Systems: Introduction, intra ocular barriers and methods to
overcome ?Preliminary study, ocular formulations and ocuserts
Intrauterine Drug Delivery Systems: Introduction, advantages and disadvantages,
development of intra uterine devices (IUDs) and applications
Recommended Books: (Latest Editions)
1. Y W. Chien, Novel Drug Delivery Systems, 2nd edition, revised and expanded,
Marcel Dekker, Inc., New York, 1992.
2. Robinson, J. R., Lee V. H. L, Controlled Drug Delivery Systems, Marcel Dekker,
Inc., New York, 1992.
3. Encyclopedia of Controlled Delivery. Edith Mathiowitz, Published by Wiley
Interscience Publication, John Wiley and Sons, Inc, New York.
Chichester/Weinheim
4. N.K. Jain, Controlled and Novel Drug Delivery, CBS Publishers & Distributors,
New Delhi, First edition 1997 (reprint in 2001).
5. S.P. Vyas and R.K. Khar, Controlled Drug Delivery -concepts and advances,
Vallabh Prakashan, New Delhi, First edition 2002.
Journals
1.
Indian Journal of Pharmaceutical Sciences (IPA)
2.
Indian Drugs (IDMA)
3.
Journal of Controlled Release (Elsevier Sciences)
4.
Drug Development and Industrial Pharmacy (Marcel & Decker)
5.
International Journal of Pharmaceutics (Elsevier Sciences)
149
SEMESTER VIII
150
BP801T. BIOSTATISITCS AND RESEARCH METHODOLOGY (Theory)
45 Hours
Scope: To understand the applications of Biostatics in Pharmacy. This subject deals with
descriptive statistics, Graphics, Correlation, Regression, logistic regression Probability
theory, Sampling technique, Parametric tests, Non Parametric tests, ANOVA,
Introduction to Design of Experiments, Phases of Clinical trials and Observational and
Experimental studies, SPSS, R and MINITAB statistical software's, analyzing the
statistical data using Excel.
Objectives: Upon completion of the course the student shall be able to
? Know the operation of M.S. Excel, SPSS, R and MINITAB?, DoE (Design
of Experiment)
? Know the various statistical techniques to solve statistical problems
? Appreciate statistical techniques in solving the problems.
Course content:
Unit-I
10 Hours
Introduction: Statistics, Biostatistics, Frequency distribution
Measures of central tendency: Mean, Median, Mode- Pharmaceutical examples
Measures of dispersion: Dispersion, Range, standard deviation, Pharmaceutical
problems
Correlation: Definition, Karl Pearson's coefficient of correlation, Multiple
correlation - Pharmaceuticals examples
Unit-II
10 Hours
Regression: Curve fitting by the method of least squares, fitting the lines y= a + bx
and x = a + by, Multiple regression, standard error of regression? Pharmaceutical
Examples
Probability:Definition of probability, Binomial distribution, Normal distribution,
Poisson's distribution, properties - problems
Sample, Population, large sample, small sample, Null hypothesis, alternative
hypothesis, sampling, essence of sampling, types of sampling, Error-I type, Error-II
type, Standard error of mean (SEM) - Pharmaceutical examples
Parametric test: t-test(Sample, Pooled or Unpaired and Paired) , ANOVA, (One way
and Two way), Least Significance difference
151
Unit-III
10 Hours
Non Parametric tests: Wilcoxon Rank Sum Test, Mann-Whitney U test, Kruskal-Wallis
test, Friedman Test
Introduction to Research: Need for research, Need for design of Experiments,
Experiential Design Technique, plagiarism
Graphs: Histogram, Pie Chart, Cubic Graph, response surface plot, Counter Plot graph
Designing the methodology: Sample size determination and Power of a study, Report
writing and presentation of data, Protocol, Cohorts studies, Observational studies,
Experimental studies, Designing clinical trial, various phases.
Unit-IV
08 Hours
Blocking and confounding system for Two-level factorials
Regression modeling: Hypothesis testing in Simple and Multiple regressionmodels
Introduction to Practical components of Industrial and Clinical Trials Problems:
Statistical Analysis Using Excel, SPSS, MINITAB?, DESIGN OF EXPERIMENTS, R -
Online Statistical Software's to Industrial and Clinical trial approach
Unit-V
07 Hours
Design and Analysis of experiments:
Factorial Design: Definition, 22, 23design. Advantage of factorial design
Response Surface methodology: Central composite design, Historical design,
Optimization Techniques
Recommended Books (Latest edition):
1. Pharmaceutical statistics- Practical and clinical applications, Sanford Bolton,
publisher Marcel Dekker Inc. New York.
2. Fundamental of Statistics ? Himalaya Publishing House- S.C.Guptha
3. Design and Analysis of Experiments ?PHI Learning Private Limited,
R. Pannerselvam,
4. Design and Analysis of Experiments ? Wiley Students Edition, Douglas and
C. Montgomery
152
BP 802T SOCIAL AND PREVENTIVE PHARMACY
Hours: 45
Scope:
The purpose of this course is to introduce to students a number of health issues and their
challenges. This course also introduced a number of national health programmes. The
roles of the pharmacist in these contexts are also discussed.
Objectives:
After the successful completion of this course, the student shall be able to:
? Acquire high consciousness/realization of current issuesrelated to health and
pharmaceutical problems within the country and worldwide.
? Have a critical way of thinking based on current healthcare development.
? Evaluate alternative ways of solving problems related to health and
pharmaceutical issues
Course content:
Unit I:
10 Hours
Concept of health and disease: Definition, concepts and evaluation of public health.
Understanding the concept of prevention and control of disease, social causes of diseases
and social problems of the sick.
Social and health education: Food in relation to nutrition and health, Balanced diet,
Nutritional deficiencies, Vitamin deficiencies, Malnutrition and its prevention.
Sociology and health: Socio cultural factors related to health and disease, Impact of
urbanization on health and disease, Poverty and health
Hygiene and health: personal hygiene and health care; avoidable habits
Unit II:
10 Hours
Preventive medicine: General principles of prevention and control of diseases such as
cholera, SARS, Ebola virus, influenza, acute respiratory infections, malaria, chicken
guinea, dengue, lymphatic filariasis, pneumonia, hypertension, diabetes mellitus, cancer,
drug addiction-drug substance abuse
Unit III:
10 Hours
National health programs, its objectives, functioning and outcome of the following:
HIV AND AIDS control programme, TB, Integrated disease surveillance program
(IDSP), National leprosy control programme, National mental health program, National
programme for prevention and control of deafness, Universal immunization programme,
National programme for control of blindness, Pulse polio programme.
153
Unit IV:
08 Hours
National health intervention programme for mother and child, National family welfare
programme, National tobacco control programme, National Malaria Prevention Program,
National programme for the health care for the elderly, Social health programme; role of
WHO in Indian national program
Unit V:
07 Hours
Community services in rural, urban and school health: Functions of PHC, Improvement
in rural sanitation, national urban health mission, Health promotion and education in
school.
Recommended Books (Latest edition):
1. Short Textbook of Preventive and Social Medicine, Prabhakara GN, 2nd Edition,
2010, ISBN: 9789380704104, JAYPEE Publications
2. Textbook of Preventive and Social Medicine (Mahajan and Gupta), Edited by Roy
Rabindra Nath, Saha Indranil, 4th Edition, 2013, ISBN: 9789350901878, JAYPEE
Publications
3. Review of Preventive and Social Medicine (Including Biostatistics), Jain Vivek, 6th
Edition, 2014, ISBN: 9789351522331, JAYPEE Publications
4. Essentials of Community Medicine--A Practical Approach, Hiremath Lalita D,
Hiremath Dhananjaya A, 2nd Edition, 2012, ISBN: 9789350250440, JAYPEE
Publications
5. Park Textbook of Preventive and Social Medicine, K Park, 21st Edition, 2011,
ISBN-14: 9788190128285, BANARSIDAS BHANOT PUBLISHERS.
6. Community Pharmacy Practice, Ramesh Adepu, BSP publishers, Hyderabad
Recommended Journals:
1. Research in Social and Administrative Pharmacy, Elsevier, Ireland
154
BP803ET. PHARMA MARKETING MANAGEMENT (Theory)
45 Hours
Scope:
The pharmaceutical industry not only needs highly qualified researchers, chemists and,
technical people, but also requires skilled managers who can take the industry forward
by managing and taking the complex decisions which are imperative for the growth of the
industry. The Knowledge and Know-how of marketing management groom the people
for taking a challenging role in Sales and Product management.
Course Objective: The course aims to provide an understanding of marketing concepts
and techniques and their applications in the pharmaceutical industry.
Unit I
10 Hours
Marketing:
Definition, general concepts and scope of marketing; Distinction between marketing &
selling; Marketing environment; Industry and competitive analysis; Analyzing consumer
buying behavior; industrial buying behavior.
Pharmaceutical market:
Quantitative and qualitative aspects; size and composition of the market; demographic
descriptions and socio-psychological characteristics of the consumer; market
segmentation& targeting.Consumer profile; Motivation and prescribing habits of the
physician; patients' choice of physician and retail pharmacist.Analyzing the Market;Role
of market research.
Unit II
10 Hours
Product decision:
Classification, product line and product mix decisions, product life
cycle,product portfolio analysis; product positioning; New product decisions; Product
branding, packaging and labeling decisions, Product management in pharmaceutical
industry.
Unit III
10 Hours
Promotion:
Methods, determinants of promotional mix, promotional budget; An overview of
personal selling, advertising, direct mail, journals, sampling, retailing, medical
exhibition, public relations, online promotional techniques for OTC Products.
155
Unit IV
10 Hours
Pharmaceutical marketing channels:
Designing channel, channel members, selecting the appropriate channel, conflict in
channels, physical distribution management: Strategic importance, tasks in physical
distribution management.
Professional sales representative (PSR):
Duties of PSR, purpose of detailing, selection and training, supervising, norms for
customer calls, motivating, evaluating, compensation and future prospects of the PSR.
Unit V
10 Hours
Pricing:
Meaning, importance, objectives, determinants of price; pricing methods and strategies,
issues in price management in pharmaceutical industry. An overview of DPCO
(Drug Price Control Order)and NPPA (National Pharmaceutical Pricing Authority).
Emerging concepts in marketing:
Vertical & Horizontal Marketing; RuralMarketing; Consumerism; Industrial Marketing;
Global Marketing.
Recommended Books: (Latest Editions)
1. Philip Kotler and Kevin Lane Keller: Marketing Management, Prentice Hall of India,
New Delhi
2. Walker, Boyd and Larreche : Marketing Strategy- Planning and Implementation, Tata
MC GrawHill, New Delhi.
3. Dhruv Grewal and Michael Levy: Marketing, Tata MC Graw Hill
4. Arun Kumar and N Menakshi: Marketing Management, Vikas Publishing, India
5. Rajan Saxena: Marketing Management; Tata MC Graw-Hill (India Edition)
6. Ramaswamy, U.S & Nanakamari, S: Marketing Managemnt:Global Perspective,
IndianContext,Macmilan India, New Delhi.
7. Shanker, Ravi: Service Marketing, Excell Books, New Delhi
8. Subba Rao Changanti, Pharmaceutical Marketing in India (GIFT ? Excel series) Excel
Publications.
156
BP804 ET: PHARMACEUTICAL REGULATORY SCIENCE (Theory)
45Hours
Scope: This course is designed to impart the fundamental knowledge on the regulatory
requirements for approval of new drugs, and drug products in regulated markets of
India & other countries like US, EU, Japan, Australia,UK etc. It prepares the students
to learn in detail on the regulatory requirements, documentation requirements, and
registration procedures for marketing the drug products.
Objectives: Upon completion of the subject student shall be able to;
1. Know about the process of drug discovery and development
2. Know the regulatory authorities and agencies governing the manufacture and sale
of pharmaceuticals
3. Know the regulatory approval process and their registration in Indian and
international markets
Course content:
Unit I
10Hours
New Drug Discovery and development
Stages of drug discovery, Drug development process, pre-clinical studies, non-clinical
activities, clinical studies, Innovator and generics, Concept of generics, Generic drug
product development.
Unit II
10Hours
Regulatory Approval Process
Approval processes and timelines involved in Investigational New Drug (IND), New
Drug Application (NDA), Abbreviated New Drug Application (ANDA). Changes to an
approved NDA / ANDA.
Regulatory authorities and agencies
Overview of regulatory authorities of India, United States, European Union, Australia,
Japan, Canada (Organization structure and types of applications)
Unit III
10Hours
Registration of Indian drug product in overseas market
Procedure for export of pharmaceutical products, Technical documentation, Drug Master
Files (DMF), Common Technical Document (CTD), electronic Common Technical
Document (eCTD), ASEAN Common Technical Document (ACTD) research.
157
Unit IV
08Hours
Clinical trials
Developing clinical trial protocols, Institutional Review Board / Independent Ethics
committee - formation and working procedures, Informed consent process and
procedures, GCP obligations of Investigators, sponsors & Monitors, Managing and
Monitoring clinical trials, Pharmacovigilance - safety monitoring in clinical trials
Unit V
07Hours
Regulatory Concepts
Basic terminology, guidance, guidelines, regulations, Laws and Acts, Orange book,
Federal Register, Code of Federal Regulatory, Purple book
Recommended books (Latest edition):
1. Drug Regulatory Affairs by Sachin Itkar, Dr. N.S. Vyawahare, Nirali Prakashan.
2. The Pharmaceutical Regulatory Process, Second Edition Edited by Ira R. Berry and
Robert P. Martin, Drugs and the Pharmaceutical Sciences,Vol.185. Informa Health
care Publishers.
3. New Drug Approval Process: Accelerating Global Registrations By Richard A
Guarino, MD, 5th edition, Drugs and the Pharmaceutical Sciences,Vol.190.
4. Guidebook for drug regulatory submissions / Sandy Weinberg. ByJohn Wiley &
Sons. Inc.
5. FDA Regulatory Affairs: a guide for prescription drugs, medical devices, and
biologics /edited by Douglas J. Pisano, David Mantus.
6. Generic Drug Product Development, Solid Oral Dosage forms, Leon Shargel and
Isader Kaufer, Marcel Dekker series, Vol.143
7. Clinical Trials and Human Research: A Practical Guide to Regulatory Compliance
By Fay A. Rozovsky and Rodney K. Adams
8. Principles and Practices of Clinical Research, Second Edition Edited by John I.
Gallin and Frederick P. Ognibene
9. Drugs: From Discovery to Approval, Second Edition By Rick Ng
158
BP 805T: PHARMACOVIGILANCE (Theory)
45 hours
Scope: This paper will provide an opportunity for the student to learn about development of
pharmacovigilance as a science, basic terminologies used in pharmacovigilance, global scenario
of Pharmacovigilance, train students on establishing pharmacovigilance programme in an
organization, various methods that can be used to generate safety data and signal detection. This
paper also develops the skills of classifying drugs, diseases and adverse drug reactions.
Objectives:
At completion of this paper it is expected that students will be able to (know, do, and
appreciate):
1. Why drug safety monitoring is important?
2. History and development of pharmacovigilance
3. National and international scenario of pharmacovigilance
4. Dictionaries, coding and terminologies used in pharmacovigilance
5. Detection of new adverse drug reactions and their assessment
6. International standards for classification of diseases and drugs
7. Adverse drug reaction reporting systems and communication in pharmacovigilance
8. Methods to generate safety data during pre clinical, clinical and post approval phases of
drugs' life cycle
9. Drug safety evaluation in paediatrics, geriatrics, pregnancy and lactation
10. Pharmacovigilance Program of India (PvPI) requirement for ADR reporting in India
11. ICH guidelines for ICSR, PSUR, expedited reporting, pharmacovigilance planning
12. CIOMS requirements for ADR reporting
13. Writing case narratives of adverse events and their quality.
Course Content
Unit I
10 Hours
Introduction to Pharmacovigilance
? History and development of Pharmacovigilance
? Importance of safety monitoring of Medicine
? WHO international drug monitoring programme
? Pharmacovigilance Program of India(PvPI)
Introduction to adverse drug reactions
? Definitions and classification of ADRs
? Detection and reporting
? Methods in Causality assessment
? Severity and seriousness assessment
? Predictability and preventability assessment
? Management of adverse drug reactions
Basic terminologies used in pharmacovigilance
? Terminologies of adverse medication related events
? Regulatory terminologies
159
Unit II
10 hours
Drug and disease classification
? Anatomical, therapeutic and chemical classification of drugs
? International classification of diseases
? Daily defined doses
? International Non proprietary Names for drugs
Drug dictionaries and coding in pharmacovigilance
? WHO adverse reaction terminologies
? MedDRA and Standardised MedDRA queries
? WHO drug dictionary
? Eudravigilance medicinal product dictionary
Information resources in pharmacovigilance
? Basic drug information resources
? Specialised resources for ADRs
Establishing pharmacovigilance programme
? Establishing in a hospital
? Establishment & operation of drug safety department in industry
? Contract Research Organisations (CROs)
? Establishing a national programme
Unit III
10 Hours
Vaccine safety surveillance
? Vaccine Pharmacovigilance
? Vaccination failure
? Adverse events following immunization
Pharmacovigilance methods
? Passive surveillance ? Spontaneous reports and case series
? Stimulated reporting
? Active surveillance ? Sentinel sites, drug event monitoring and registries
? Comparative observational studies ? Cross sectional study, case control study and
cohort study
? Targeted clinical investigations
Communication in pharmacovigilance
? Effective communication in Pharmacovigilance
? Communication in Drug Safety Crisis management
? Communicating with Regulatory Agencies, Business Partners, Healthcare facilities &
Media
160
Unit IV
8 Hours
Safety data generation
? Pre clinical phase
? Clinical phase
? Post approval phase (PMS)
ICH Guidelines for Pharmacovigilance
? Organization and objectives of ICH
? Expedited reporting
? Individual case safety reports
? Periodic safety update reports
? Post approval expedited reporting
? Pharmacovigilance planning
? Good clinical practice in pharmacovigilance studies
Unit V
7 hours
Pharmacogenomics of adverse drug reactions
? Genetics related ADR with example focusing PK parameters.
Drug safety evaluation in special population
? Paediatrics
? Pregnancy and lactation
? Geriatrics
CIOMS
? CIOMS Working Groups
? CIOMS Form
CDSCO (India) and Pharmacovigilance
? D&C Act and Schedule Y
? Differences in Indian and global pharmacovigilance requirements
161
Recommended Books (Latest edition):
1. Textbook of Pharmacovigilance: S K Gupta, Jaypee Brothers, Medical Publishers.
2. Practical Drug Safety from A to Z By Barton Cobert, Pierre Biron, Jones and
Bartlett Publishers.
3. Mann's Pharmacovigilance:Elizabeth B. Andrews, Nicholas, Wiley Publishers.
4. Stephens' Detection of New Adverse Drug Reactions: John Talbot, Patrick Walle,
Wiley Publishers.
5. An Introduction to Pharmacovigilance: Patrick Waller,Wiley Publishers.
6. Cobert's Manual of Drug Safety and Pharmacovigilance: Barton Cobert,Jones&
Bartlett Publishers.
7. Textbook of Pharmacoepidemiolog edited by Brian L. Strom, Stephen E Kimmel,
Sean Hennessy,Wiley Publishers.
8. A Textbook of Clinical Pharmacy Practice -Essential Concepts and Skills:G.
Parthasarathi, Karin NyfortHansen,Milap C. Nahata
9. National Formulary of India
10. Text Book of Medicine by Yashpal Munjal
11. Text book of Pharmacovigilance: concept and practice by GP Mohanta and PK
Manna
12. http://www.whoumc.org/DynPage.aspx?id=105825&mn1=7347&mn2=7259&mn
3=7297
13. http://www.ich.org/
14. http://www.cioms.ch/
15. http://cdsco.nic.in/
16. http://www.who.int/vaccine_safety/en/
17. http://www.ipc.gov.in/PvPI/pv_home.html
162
BP 806 ET. QUALITY CONTROL AND STANDARDIZATION OF HERBALS
(Theory)
Scope: In this subject the student learns about the various methods and guidelines for
evaluation and standardization of herbs and herbal drugs. The subject also provides an
opportunity for the student to learn cGMP, GAP and GLP in traditional system of
medicines.
Objectives: Upon completion of the subject student shall be able to;
1. know WHO guidelines for quality control of herbal drugs
2. know Quality assurance in herbal drug industry
3. know the regulatory approval process and their registration in Indian and
international markets
4. appreciate EU and ICH guidelines for quality control of herbal drugs
Unit I
10 hours
Basic tests for drugs ? Pharmaceutical substances, Medicinal plants materials and
dosage forms.
WHO guidelines for quality control of herbal drugs. Evaluation of commercial crude
drugs intended for use
Unit II
10 hours
Quality assurance in herbal drug industry of cGMP, GAP, GMP and GLP in
traditional system of medicine.
WHO Guidelines on current good manufacturing Practices (cGMP) for Herbal
Medicines WHO Guidelines on GACP for Medicinal Plants.
Unit III
10 hours
EU and ICH guidelines for quality control of herbal drugs.
Research Guidelines for Evaluating the Safety and Efficacy of Herbal Medicines
Unit IV
08 hours
Stability testing of herbal medicines.Application of various chromatographic
techniques in standardization of herbal products. Preparation of documents for new
drug application and export registration GMP requirements and Drugs & Cosmetics
Act provisions.
163
Unit V
07 hours
Regulatory requirements for herbal medicines. WHO guidelines on safety
monitoring of herbal medicines in pharmacovigilance systems, Comparison of
various Herbal Pharmacopoeias. Role of chemical and biological markers in
standardization of herbal products
Recommended Books: (Latest Editions
1. Pharmacognosy by Trease and Evans
2. Pharmacognosy by Kokate, Purohit and Gokhale
3. Rangari, V.D., Text book of Pharmacognosy and Phytochemistry Vol. I , Carrier
Pub., 2006.
4. Aggrawal, S.S., Herbal Drug Technology. Universities Press, 2002.
5. EMEA. Guidelines on Quality of Herbal Medicinal Products/Traditional Medicinal
Products,
6. Mukherjee, P.W. Quality Control of Herbal Drugs: An Approach to Evaluation of
Botanicals. Business Horizons Publishers, New Delhi, India, 2002.
7. Shinde M.V., Dhalwal K., Potdar K., Mahadik K. Application of quality control
principles to herbal drugs. International Journal of Phytomedicine 1(2009); p. 4-8.
8. WHO. Quality Control Methods for Medicinal Plant Materials, World Health
Organization, Geneva, 1998. WHO. Guidelines for the Appropriate Use of Herbal
Medicines. WHO Regional Publications, Western Pacific Series No 3, WHO
Regional office for the Western Pacific, Manila, 1998.
9. WHO. The International Pharmacopeia, Vol. 2: Quality Specifications, 3rd edn.
World Health Organization, Geneva, 1981.
10. WHO. Quality Control Methods for Medicinal Plant Materials. World Health
Organization, Geneva, 1999.
11. WHO. WHO Global Atlas of Traditional, Complementary and Alternative
Medicine. 2 vol. set. Vol. 1 contains text and Vol. 2, maps. World Health
Organization, Geneva, 2005.
12. WHO. Guidelines on Good Agricultural and Collection Practices (GACP) for
Medicinal Plants. World Health Organization, Geneva, 2004.
164
BP 807 ET. COMPUTER AIDED DRUG DESIGN (Theory)
45 Hours
Scope: This subject is designed to provide detailed knowledge of rational drug design
process and various techniques used in rational drug design process.
Objectives: Upon completion of the course, the student shall be able to understand
? Design and discovery of lead molecules
? The role of drug design in drug discovery process
? The concept of QSAR and docking
? Various strategies to develop new drug like molecules.
? The design of new drug molecules using molecular modeling software
Course Content:
UNIT-I
10 Hours
Introduction to Drug Discovery and Development
Stages of drug discovery and development
Lead discovery and Analog Based Drug Design
Rational approaches to lead discovery based on traditional medicine,
Random screening, Non-random screening, serendipitous drug discovery,
lead discovery based on drug metabolism, lead discovery based on clinical
observation.
Analog Based Drug Design: Bioisosterism, Classification, Bioisosteric
replacement. Any three case studies
UNIT-II
10 Hours
Quantitative Structure Activity Relationship (QSAR)
SAR versus QSAR, History and development of QSAR, Types of
physicochemical parameters, experimental and theoretical approaches for
the determination of physicochemical parameters such as Partition
coefficient, Hammet's substituent constant and Tafts steric constant.
Hansch analysis, Free Wilson analysis, 3D-QSAR approaches like
COMFA and COMSIA.
UNIT-III
10 Hours
Molecular Modeling and virtual screening techniques
Virtual Screening techniques: Drug likeness screening, Concept of
pharmacophore mapping and pharmacophore based Screening,
Molecular docking: Rigid docking, flexible docking, manual docking,
Docking based screening. De novo drug design.
165
UNIT-IV
08 Hours
Informatics & Methods in drug design
Introduction to Bioinformatics, chemoinformatics. ADME databases,
chemical, biochemical and pharmaceutical databases.
UNIT-V
07 Hours
Molecular Modeling: Introduction to molecular mechanics and quantum
mechanics.Energy Minimization methods and Conformational Analysis,
global conformational minima determination.
Recommended Books (Latest Editions)
1. Robert GCK, ed., "Drug Action at the Molecular Level" University Prak Press Baltimore.
2. Martin YC. "Quantitative Drug Design" Dekker, New York.
3. Delgado JN, Remers WA eds "Wilson & Gisvolds's Text Book of Organic
Medicinal & Pharmaceutical Chemistry" Lippincott, New York.
4. Foye WO "Principles of Medicinal chemistry `Lea & Febiger.
5. Koro lkovas A, Burckhalter JH. "Essentials of Medicinal Chemistry" Wiley
Interscience.
6. Wolf ME, ed "The Basis of Medicinal Chemistry, Burger's Medicinal Chemistry"
John Wiley & Sons, New York.
7. Patrick Graham, L., An Introduction to Medicinal Chemistry, Oxford University
Press.
8. Smith HJ, Williams H, eds, "Introduction to the principles of Drug Design"
Wright Boston.
9. Silverman R.B. "The organic Chemistry of Drug Design and Drug Action"
Academic Press New York.
166
BP808ET: CELL AND MOLECULAR BIOLOGY (Elective subject)
45 Hours
Scope:
? Cell biology is a branch of biology that studies cells ? their physiological
properties, their structure, the organelles they contain, interactions with their
environment, their life cycle, division, death and cell function.
? This is done both on a microscopic and molecular level.
? Cell biology research encompasses both the great diversity of single-celled
organisms like bacteria and protozoa, as well as the many specialized cells in
multi-cellular organismssuch as humans, plants, and sponges.
Objectives: Upon completion of the subject student shall be able to;
? Summarize cell and molecular biologyhistory.
? Summarize cellular functioning and composition.
? Describe the chemical foundations of cell biology.
? Summarize the DNA properties of cell biology.
? Describe protein structure and function.
? Describe cellular membrane structure and function.
? Describe basic molecular genetic mechanisms.
? Summarize the Cell Cycle
Course content:
Unit I
10Hours
a) Cell and Molecular Biology: Definitions theory and basics and Applications.
b) Cell and Molecular Biology: History and Summation.
c) Properties of cells and cell membrane.
d) Prokaryotic versus Eukaryotic
e) Cellular Reproduction
f) Chemical Foundations ? an Introduction and Reactions (Types)
Unit II
10 Hours
a) DNA and the Flow of Molecular Information
b) DNA Functioning
c) DNA and RNA
d) Types of RNA
e) Transcription and Translation
167
Unit III
10 Hours
a) Proteins: Defined and Amino Acids
b) Protein Structure
c) Regularities in Protein Pathways
d) Cellular Processes
e) Positive Control and significance of Protein Synthesis
Unit IV
08 Hours
a) Science of Genetics
b) Transgenics and Genomic Analysis
c) Cell Cycle analysis
d) Mitosis and Meiosis
e) Cellular Activities and Checkpoints
Unit V
07 Hours
a) Cell Signals: Introduction
b) Receptors for Cell Signals
c) Signaling Pathways: Overview
d) Misregulation of Signaling Pathways
e) Protein-Kinases: Functioning
Recommended Books (latest edition):
1. W.B. Hugo and A.D. Russel: Pharmaceutical Microbiology, Blackwell Scientific
publications, Oxford London.
2. Prescott and Dunn., Industrial Microbiology, 4th edition, CBS Publishers &
Distributors, Delhi.
3. Pelczar, Chan Kreig, Microbiology, Tata McGraw Hill edn.
4. Malcolm Harris, Balliere Tindall and Cox: Pharmaceutical Microbiology.
5. Rose: Industrial Microbiology.
6. Probisher, Hinsdill et al: Fundamentals of Microbiology, 9th ed. Japan
7. Cooper and Gunn's: Tutorial Pharmacy, CBS Publisher and Distribution.
8. Peppler: Microbial Technology.
9. Edward: Fundamentals of Microbiology.
10. N.K.Jain: Pharmaceutical Microbiology, Vallabh Prakashan, Delhi
11. Bergeys manual of systematic bacteriology, Williams and Wilkins- A Waverly
company
12. B.R. Glick and J.J. Pasternak: Molecular Biotechnology: Principles and
Applications of RecombinantDNA: ASM Press Washington D.C.
13. RA Goldshy et. al., : Kuby Immunology.
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BP809ET. COSMETIC SCIENCE (Theory)
45Hours
UNIT I
10Hours
Classification of cosmetic and cosmeceutical products
Definition of cosmetics as per Indian and EU regulations, Evolution of cosmeceuticals
from cosmetics, cosmetics as quasi and OTC drugs
Cosmetic excipients: Surfactants, rheology modifiers, humectants, emollients,
preservatives. Classification and application
Skin: Basic structure and function of skin.
Hair: Basic structure of hair. Hair growth cycle.
Oral Cavity: Common problem associated with teeth and gums.
UNIT II
10 Hours
Principles of formulation and building blocks of skin care products:
Face wash,
Moisturizing cream, Cold Cream, Vanishing cream and their advantages and
disadvantages.Application of these products in formulation of cosmecuticals.
Antiperisprants & deodorants- Actives & mechanism of action.
Principles of formulation and building blocks of Hair care products:
Conditioning shampoo, Hair conditioner,anti-dandruff shampoo.
Hair oils.
Chemistry and formulation of Para-phylene diamine based hair dye.
Principles of formulation and building blocks of oral care products:
Toothpaste for bleeding gums, sensitive teeth. Teeth whitening, Mouthwash.
UNIT III
10 Hours
Sun protection, Classification of Sunscreens and SPF.
Role of herbs in cosmetics:
Skin Care: Aloe and turmeric
Hair care: Henna and amla.
Oral care: Neem and clove
Analytical cosmetics: BIS specification and analytical methods for shampoo, skin-
cream and toothpaste.
UNIT IV
08 Hours.
Principles of Cosmetic Evaluation:Principles of sebumeter, corneometer. Measurement
of TEWL, Skin Color, Hair tensile strength, Hair combing properties
Soaps,and syndet bars. Evolution and skin benfits.
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UNIT V
07 Hours
Oily and dry skin, causes leading to dry skin, skin moisturisation. Basic understanding of
the terms Comedogenic, dermatitis.
Cosmetic problems associated with Hair and scalp: Dandruff, Hair fall causes
Cosmetic problems associated with skin: blemishes, wrinkles, acne, prickly heat and
body odor.
Antiperspirants and Deodorants- Actives and mechanism of action
References
1) Harry's Cosmeticology, Wilkinson, Moore, Seventh Edition, George Godwin.
2) Cosmetics ? Formulations, Manufacturing and Quality Control, P.P. Sharma, 4th
Edition, Vandana Publications Pvt. Ltd., Delhi.
3) Text book of cosmelicology by Sanju Nanda & Roop K. Khar, Tata Publishers.
170
BP810 ET. PHARMACOLOGICAL SCREENING METHODS
45 Hours
Scope: This subject is designed to impart the basic knowledge of preclinical studies
in experimental animals including design, conduct and interpretations of results.
Objectives
Upon completion of the course the student shall be able to,
? Appreciate the applications of various commonly used laboratory animals.
? Appreciate and demonstrate the various screening methods used in preclinical
research
? Appreciate and demonstrate the importance of biostatistics and researchmethodology
? Design and execute a research hypothesis independently
Unit ?I
08 Hours
Laboratory Animals:
Study of CPCSEA and OECD guidelines for maintenance, breeding and
conduct of experiments on laboratory animals, Common lab animals:
Description and applications of different species and strains of animals.
Popular transgenic and mutant animals.
Techniques for collection of blood and common routes of drug
administration in laboratory animals, Techniques of blood collection and
euthanasia.
Unit ?II
10 Hours
Preclinical screening models
a. Introduction: Dose selection, calculation and conversions,
preparation of drug solution/suspensions, grouping of animals and
importance of sham negative and positive control groups.
Rationale for selection of animal species and sex for the study.
b. Study of screening animal models for
Diuretics, nootropics, anti-Parkinson's,antiasthmatics,
Preclinical screening models: for CNS activity- analgesic,
antipyretic,anti-inflammatory, general anaesthetics, sedative and
hypnotics,
antipsychotic,
antidepressant,
antiepileptic,
antiparkinsonism, alzheimer's disease
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Unit ?III
10 Hours
Preclinical screening models: for ANS activity, sympathomimetics,
sympatholytics, parasympathomimetics, parasympatholytics, skeletal
muscle relaxants, drugs acting on eye, local anaethetics
Unit ?IV
12 Hours
Preclinical screening models: for CVS activity- antihypertensives,
diuretics, antiarrhythmic, antidyslepidemic, anti aggregatory,
coagulants, and anticoagulants
Preclinical screening models for other important drugs like antiulcer,
antidiabetic, anticancer and antiasthmatics.
Unit - V
05 Hours
Research methodology and Bio-statistics
Selection of research topic, review of literature, research hypothesis
and study design
Pre-clinical data analysis and interpretation using Students `t' test and
One-way ANOVA. Graphical representation of data
Recommended Books (latest edition):
1. Fundamentals of experimental Pharmacology-by M.N.Ghosh
2. Hand book of Experimental Pharmacology-S.K.Kulakarni
3. CPCSEA guidelines for laboratory animal facility.
4. Drug discovery and Evaluation by Vogel H.G.
5. Drug Screening Methods by Suresh Kumar Gupta and S. K. Gupta
6. Introduction to biostatistics and research methods by PSS Sundar Rao and J
Richard
172
BP 811 ET. ADVANCED INSTRUMENTATION TECHNIQUES
45 Hours
Scope: This subject deals with the application of instrumental methods in qualitative and
quantitative analysis of drugs. This subject is designed to impart advanced knowledge on
the principles and instrumentation of spectroscopic and chromatographic hyphenated
techniques. This also emphasizes on theoretical and practical knowledge on modern
analytical instruments that are used for drug testing.
Objectives:Upon completion of the course the student shall be able to
? understand the advanced instruments used and its applications in drug analysis
? understand the chromatographic separation and analysis of drugs.
? understand the calibration of various analytical instruments
? know analysis of drugs using various analytical instruments.
Course Content:
UNIT-I
10 Hours
Nuclear Magnetic Resonance spectroscopy
Principles of H-NMR and C-NMR, chemical shift, factors affecting chemical
shift, coupling constant, Spin - spin coupling, relaxation, instrumentation and
applications
Mass Spectrometry- Principles, Fragmentation, Ionization techniques ?
Electron impact, chemical ionization, MALDI, FAB, Analyzers-Time of
flight and Quadrupole, instrumentation, applications
UNIT-II
10 Hours
Thermal Methods of Analysis: Principles, instrumentation and applications
of ThermogravimetricAnalysis (TGA), Differential Thermal Analysis (DTA),
Differential Scanning Calorimetry (DSC).
X-Ray Diffraction Methods: Origin of X-rays, basic aspects of crystals,
x-ray
crystallography,
rotating
crystal
technique, single
crystal
diffraction,powder diffraction, structural elucidation and applications.
UNIT-III
10 Hours
Calibration and validation-as per ICH and USFDA guidelines
Calibration of following Instruments
Electronic balance, UV-Visible spectrophotometer, IR spectrophotometer,
Fluorimeter, Flame Photometer, HPLC and GC
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UNIT-IV
08 Hours
Radio immune assay:Importance, various components, Principle, different
methods, Limitation and Applications of Radio immuno assay
Extraction techniques:General principle and procedure involved in the solid
phase extraction and liquid-liquid extraction
UNIT-V
07 Hours
Hyphenated techniques-LC-MS/MS, GC-MS/MS, HPTLC-MS.
Recommended Books (Latest Editions)
1. Instrumental Methods of Chemical Analysis by B.K Sharma
2. Organic spectroscopy by Y.R Sharma
3. Text book of Pharmaceutical Analysis by Kenneth A. Connors
4. Vogel's Text book of Quantitative Chemical Analysis by A.I. Vogel
5. Practical Pharmaceutical Chemistry by A.H. Beckett and J.B. Stenlake
6. Organic Chemistry by I. L. Finar
7. Organic spectroscopy by William Kemp
8. Quantitative Analysis of Drugs by D. C. Garrett
9. Quantitative Analysis of Drugs in Pharmaceutical Formulations by P. D. Sethi
10. Spectrophotometric identification of Organic Compounds by Silverstein
174
BP 812 ET. DIETARY SUPPLEMENTS AND NUTRACEUTICALS
No. of hours :3
Tutorial:1
Credit point:4
Scope :
This subject covers foundational topic that are important for understanding the need and
requirements of dietary supplements among different groups in the population.
Objective:
This module aims to provide an understanding of the concepts behind the theoretical
applications of dietary supplements. By the end of the course, students should be able to :
1. Understand the need of supplements by the different group of people to maintain
healthy life.
2. Understand the outcome of deficiencies in dietary supplements.
3. Appreciate the components in dietary supplements and the application.
4. Appreciate the regulatory and commercial aspects of dietary supplements including
health claims.
UNIT I
07 hours
a. Definitions of Functional foods, Nutraceuticals and Dietary supplements. Classification
of Nutraceuticals, Health problems and diseases that can be prevented or cured by
Nutraceuticals i.e. weight control, diabetes, cancer, heart disease, stress, osteoarthritis,
hypertension etc.
b. Public health nutrition, maternal and child nutrition, nutrition and ageing, nutrition
education in community.
c. Source, Name of marker compounds and their chemical nature, Medicinal uses and
health benefits of following used as nutraceuticals/functional foods: Spirulina,
Soyabean, Ginseng, Garlic, Broccoli, Gingko, Flaxseeds
UNIT II
15 hours
Phytochemicals as nutraceuticals: Occurrence and characteristic features(chemical nature
medicinal benefits) of following
a) Carotenoids- and -Carotene, Lycopene, Xanthophylls, leutin
b) Sulfides: Diallyl sulfides, Allyl trisulfide.
c) Polyphenolics: Reservetrol
d) Flavonoids- Rutin , Naringin, Quercitin, Anthocyanidins, catechins, Flavones
e) Prebiotics / Probiotics.: Fructo oligosaccharides, Lacto bacillum
f) Phyto estrogens : Isoflavones, daidzein, Geebustin, lignans
g) Tocopherols
h) Proteins, vitamins, minerals, cereal, vegetables and beverages as functional foods: oats,
wheat bran, rice bran, sea foods, coffee, tea and the like.
175
UNIT III
07 hours
a) Introduction to free radicals: Free radicals, reactive oxygen species, production of free
radicals in cells, damaging reactions of free radicals on lipids, proteins,
Carbohydrates, nucleic acids.
b) Dietary fibres and complex carbohydrates as functional food ingredients..
UNIT IV
10 hours
a) Free radicals in Diabetes mellitus, Inflammation, Ischemic reperfusion injury, Cancer,
Atherosclerosis, Free radicals in brain metabolism and pathology, kidney damage,
muscle damage. Free radicals involvement in other disorders. Free radicals theory of
ageing.
b)
Antioxidants: Endogenous antioxidants ? enzymatic and nonenzymatic
antioxidant defence, Superoxide dismutase, catalase, Glutathione peroxidase,
Glutathione Vitamin C, Vitamin E, - Lipoic acid, melatonin
Synthetic antioxidants: Butylated hydroxy Toluene, Butylated hydroxy Anisole.
c) Functional foods for chronic disease prevention
UNIT V
06 hours
a) Effect of processing, storage and interactions of various environmental factors on the
potential of nutraceuticals.
b) Regulatory Aspects; FSSAI, FDA, FPO, MPO, AGMARK. HACCP and GMPs on Food
Safety. Adulteration of foods.
c) Pharmacopoeial Specifications for dietary supplements and nutraceuticals.
References:
1. Dietetics by Sri Lakshmi
2. Role of dietary fibres and neutraceuticals in preventing diseases by K.T Agusti and
P.Faizal: BSPunblication.
3. Advanced Nutritional Therapies by Cooper. K.A., (1996).
4. The Food Pharmacy by Jean Carper, Simon & Schuster, UK Ltd., (1988).
5. Prescription for Nutritional Healing by James F.Balch and Phyllis A.Balch 2nd Edn.,
Avery Publishing Group, NY (1997).
6. G. Gibson and C.williams Editors 2000 Functional foods Woodhead Publ.Co.London.
7. Goldberg, I. Functional Foods. 1994. Chapman and Hall, New York.
8. Labuza, T.P. 2000 Functional Foods and Dietary Supplements: Safety, Good
Manufacturing Practice (GMPs) and Shelf Life Testing in Essentials of Functional
Foods M.K. Sachmidl and T.P. Labuza eds. Aspen Press.
9. Handbook of Nutraceuticals and Functional Foods, Third Edition (Modern Nutrition)
10. Shils, ME, Olson, JA, Shike, M. 1994 Modern Nutrition in Health and Disease. Eighth
edition. Lea and Febiger
176
Semester VIII ? Elective course on Pharmaceutical Product Development
No of Hours: 3
Tutorial:1
Credit points:4
Unit-I
10 Hours
Introduction to pharmaceutical product development, objectives, regulations related to
preformulation, formulation development, stability assessment, manufacturing and
quality control testing of different types of dosage forms
Unit-II
10 Hours
An advanced study of Pharmaceutical Excipients in pharmaceutical product development
with a special reference to the following categories
i.
Solvents and solubilizers
ii.
Cyclodextrins and their applications
iii.
Non - ionic surfactants and their applications
iv.
Polyethylene glycols and sorbitols
v.
Suspending and emulsifying agents
vi.
Semi solid excipients
Unit-III
10 Hours
An advanced study of Pharmaceutical Excipients in pharmaceutical product development
with a special reference to the following categories
i.
Tablet and capsule excipients
ii.
Directly compressible vehicles
iii.
Coat materials
iv.
Excipients in parenteral and aerosols products
v.
Excipients for formulation of NDDS
Selection and application of excipients in pharmaceutical formulations with specific
industrial applications
Unit-IV
08 Hours
Optimization techniques in pharmaceutical product development.A study of various
optimization techniques for pharmaceutical product development with specific
examples.Optimization by factorial designs and their applications.A study of QbD and its
application in pharmaceutical product development.
Unit-V
07 Hours
Selection and quality control testing of packaging materials for pharmaceutical product
development- regulatory considerations.
177
Recommended Books (Latest editions)
1. Pharmaceutical Statistics Practical and Clinical Applications byStanford Bolton,
CharlesBon; Marcel Dekker Inc.
2. Encyclopedia of Pharmaceutical Technology, edited by James swarbrick, Third
Edition, Informa Healthcare publishers.
3. Pharmaceutical Dosage Forms, Tablets, Volume II, edited by Herbert A. Lieberman
andLeon Lachman; Marcel Dekker, Inc.
4. The Theory and Practice of Industrial Pharmacy, Fourth Edition, edited by Roop
kKhar, S P Vyas, Farhan J Ahmad, Gaurav K Jain; CBS Publishers and Distributors
Pvt.Ltd. 2013.
5. Martin's Physical Pharmacy and Pharmaceutical Sciences, Fifth Edition, edited by
Patrick J. Sinko, BI Publications Pvt. Ltd.
6. Targeted and Controlled Drug Delivery, Novel Carrier Systems by S. P. Vyas and
R. K.Khar, CBS Publishers and Distributors Pvt. Ltd, First Edition 2012.
7. Pharmaceutical Dosage Forms and Drug Delivery Systems, Loyd V. Allen Jr.,
Nicholas B.Popovich, Howard C. Ansel, 9th Ed. 40
8. Aulton's Pharmaceutics ? The Design and Manufacture of Medicines, Michael E.
Aulton,3rd Ed.
9. Remington ? The Science and Practice of Pharmacy, 20th Ed.
10. Pharmaceutical Dosage Forms ? Tablets Vol 1 to 3, A. Liberman, Leon Lachman
andJoseph B. Schwartz
11. Pharmaceutical Dosage Forms ? Disperse Systems Vol 1 to 3, H.A. Liberman,
Martin, M.R and Gilbert S. Banker.
12. Pharmaceutical Dosage Forms ? Parenteral Medication Vol 1 & 2, Kenneth E. Avis
andH.A. Libermann.
13. Advanced Review Articles related to the topics.
178
This post was last modified on 16 March 2021