Download GTU B.Pharma 2020 Winter 7th Sem 2270001 Dosage Form Design I Question Paper

Download GTU (Gujarat Technological University Ahmedabad) B.Pharma (Bachelor of Pharmacy) 2020 Winter 7th Sem 2270001 Dosage Form Design I Previous Question Paper

Seat No.: _____ Enrolment No. _____________
GUJARAT TECHNOLOGICAL UNIVERSITY
B.Pharm- SEMESTER?VII ? EXAMINATION ? WINTER -2020
Subject Code: 2270001
Date:01/01/2021
Subject Name: Dosage Form Design-I
Time: 10:30AM To 12:30PM
Total Marks: 54
Instructions:


1. Attempt any THREE questions from Q-1 to Q-6.
2. Q.7 is compulsory to attempt.
3. Make suitable assumptions wherever necessary.
4. Figures to the right indicate full marks.

Q.1 (a) What is Preformulation? Discuss the significance of particle size and shape in
06
formulation.

(b) Explain the role of polymorphism and crystallinity in Preformulation. Enlist the 05
methods to identify polymorphism.

(c) Enlist the chemical properties observed during preformulation study. Explain
05
oxidation and reduction in detail.



Q.2 (a) Classify the polymers. Discuss in brief about polymer properties.
06

(b) Write a short note on "Plasma Protein Binding".
05

(c) Write a short note on Natural Gums.
05



Q.3 (a) Explain various methods used for enhancement of bioavailability.
06

(b) Explain the role of Biopharmaceutics in formulation development.
05

(c) Discuss the regulatory requirements for conduction of bio-equivalence
05
Studies.



Q.4 (a) Write a note on factors affecting drug absorption.
06

(b) Define i) Bioavailability ii) Cmax iii) tmax iv) Overage v) Mean Kinetic
05
Temperature

(c) What is IVIVC? Describe In-vitro -In-vivo correlations levels.
05



Q.5 (a) What is BCS classification? How does it affect development of dosage form?
06

(b) Discuss Matrixing and Bracketing Techniques.
05

(c) Effect of pKa and pH on absorption parameter.
05



Q. 6 (a) Define Half-life and Self life. Discus about international climatic zones as per
06
ICH guideline

(b) Discuss the factors affecting stability of pharmaceutical formulation.
05

(c) Discuss the effect of containers and closures on stability of pharmaceuticals.
05



Q.7 (a) Discuss stability testing of new drug substances and products as per ICH
06
guideline.
OR

(a) Write a note on volume of distribution.
06
OR

(a) Storage conditions for stability testing as per ICH guidelines.
06
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