Download GTU B.Pharma 2017 Winter 7th Sem Dosage Form Design I Question Paper

Download GTU (Gujarat Technological University) B.Pharma (Bachelor of Pharmacy) 2017 Winter 7th Sem Dosage Form Design I Previous Question Paper

Seat No.: ________
Enrolment No.______________
GUJARAT TECHNOLOGICAL UNIVERSITY
B.Pharm - SEMESTER VII ? EXAMINATION - WINTER 2017

Subject code: 270001

Date: 02-11-2017
Subject Name: Dosage Form Design- I
Time: 10:30 am to 01:30 pm




Total Marks: 80
Instructions:
1. Attempt any five questions.
2. Make suitable assumptions wherever necessary.
3. Figures to the right indicate full marks.

Q.1 (a) Define Preformulation. Enumerate outline of the principle areas of 06
prefromulation research. Discuss in details about bulk characterization in
preformulation.

(b) Discuss the significance of solubility and dissolution on formulation, stability and 05
bioavailability of dosage form.

(c) Define polymorphism. Give their types. Discuss the importance of polymorphism 05
in preformulation.


Q.2 (a) Write a note on Improvement of stability and oral bioavailability using prodrugs.
06

(b) Explain following terms for preformulation drug characterization: Hydrolysis, 05
Oxidation, Photolysis, pH, Excipient compatibility

(c) Discuss the methods to ascertain the order of a reaction.
05


Q.3 (a) Give significance of any two with suitable examples:
06
Antioxidants, preservatives, colouring agents, flavoring agents

(b) Enumerate excipients used in solid dosage form. Discuss diluents and binders in 05
details.

(c) Write a short note on suspending agents and emulsifiers with examples.
05


Q.4 (a) Write a short note on Accelerated Stability Studies.
06

(b) Discuss bracketing and matrixing designs for stability testing of drug substances 05
and drug products as per ICH guidelines.

(c) Explain shelf life and overages? Describe calculation of overages.
05


Q.5 (a) Enumerate the mechanisms of drug absorption. Discuss passive diffusion in 06
detail.

(b) Enumerate factors affecting GI absorption of a drug from its dosage form.
05

(c) Enumerate Physiologic barriers to drug distribution in the body. Explain Blood ? 05
Brain barrier in detail.


Q. 6 (a) Define Bioavailability. What are objectives of Bioavailability studies? Enumerate 06
the factors affecting Bioavailability of a drug from its dosage form.

(b) Describe Type I dissolution apparatus with a labeled diagram.
05

(c) Discuss the factors affecting renal excretion of drugs.
05


Q. 7 (a) Write a short note on pharmacokinetic methods to measures bioavailability.
06

(b) Enumerate factors influencing the drug dissolution that are related to 05
physicochemical properties of drugs. Explain any two in details.
(c) Give equations of similarity factor (f2) and dissimilarity factor (f1) for Dissolution 05
profile comparison.
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