Seat No.: Enrolment No.
GUJARAT TECHNOLOGICAL UNIVERSITY
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B.PHARM - SEMESTER- 7 EXAMINATION - SUMMER -2020
Subject Code: 2270001 Date:26-10-2020
Subject Name: Dosage form Design I
Time: 2:30 PM TO 5:30 PM Total Marks: 80
Instructions:
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- Attempt any five questions.
- Make suitable assumptions wherever necessary.
- Figures to the right indicate full marks.
Q.1 (a) Define Pre-Formulation study. Enlist techniques used in it. Describe any one of them to ascertain Drug-Excipient Compatibility. 06
(b) Explain the influence of chemical properties of drugs on formulation and stability of the products. 05
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(c) Explain: 1) Overages 2) Climatic Zones. 05
Q.2 (a) Discuss Effect of physical properties of drug like physical form, particle size and shape on formulation, stability and bioavailability. 06
(b) Enlist additives used in tablet dosages form. Discuss the anti frictional agents. 05
(c) Write a note on prodrugs. 05
Q.3 (a) Classify additives used in pharmaceutical formulations. Describe in detail about suspending agents. 06
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(b) Discuss stability testing of new drug substances and products as per ICH Guideline. 05
(c) Explain the characteristics of ‘Active transport process. Write their application in the development of formulation and administration of drugs. 05
Q.4 (a) Discuss the factors-affecting stability of pharmaceutical formulation. 06
(b) Describe Matrixing and bracketing in stability study. 05
(c) What is IVIVC? Describe In-vitro - In-vivo correlations levels. 05
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Q.5 (a) Enumerate the factors affecting drug absorption from GIT. Discuss the effect of gastric emptying, drug pKa and GI pH on drug absorption. 06
(b) Discuss plasma protein drug binding. 05
(c) Enumerate the drug transport mechanisms. Discuss passive diffusion in detail. 05
Q.6 (a) Write a note on similarity factor and dissimilarity factor. 06
(b) Classify the methods for bioavailability measurement. Discuss the method based on plasma data. 05
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(c) Define absolute and relative bioavailability. Describe Latin Square cross over design for bioequivalence study. 05
Q.7 (a) What is BCS? Classify and give the significance of this system 06
(b) Discuss the factors affecting drug dissolution. 05
(c) Explain USP dissolution apparatus III, IV and V with diagram. 05
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