GTU B.Pharm 2019 Summer Question Papers || Gujarat Technological University
Seat No.:
Subject Code: 270001
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Enrolment No.
GUJARAT TECHNOLOGICAL UNIVERSITY
B.PHARM - SEMESTER- 7 EXAMINATION - SUMMER -2019
Subject Name: Dosage Form Design- 1
Time: 02:30 PM TO 05:30 PM
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Instructions:
- Attempt any five questions.
- Make suitable assumptions wherever necessary.
- Figures to the right indicate full marks.
- (a) Discuss the significance of solubility and dissolution on formulation, stability and bioavailability of dosage form. (06)
- (b) Explain the physicochemical properties of drug substance that affect the absorption of drug. (05)
- (a) What is therapeutic equivalence? Enlist various in-vivo and in-vitro approaches that can be utilized to establish bioequivalence. (05)
- (b) Write a note on Polymorphism giving examples. (06)
- (c) Write a note on Improvement of stability and oral bioavailability using prodrugs. (05)
- (a) What is BCS? Classify and give the significance of this system. (05)
- (b) Discuss different approaches for prevention of chemical degradation of pharmaceuticals. (06)
- (c) Storage conditions for stability testing as per ICH guidelines. (05)
- (a) Describe active transport and passive diffusion mechanism for absorption. (05)
- (b) Explain USP dissolution apparatus III, IV and V with diagram. (06)
- (c) Write a note on suspending agents and emulsifiers used in liquid formulations. (05)
- (a) Explain kinetic involved in protein drug binding with description of plots. (05)
- (b) Discuss bracketing and matrixing designs for stability testing of drug substances and drug products as per ICH guidelines. (06)
- (c) Explain renal clearance. (05)
- (a) Explain photodegradation and its prevention. (05)
- (b) What are the objectives of bioavailability study? Explain measurement of bioavailability by Plasma level-time study. (06)
- (c) Define Intrinsic dissolution rate. Discuss factors affecting rate of dissolution. (05)
- (a) Write a brief note on overages. (05)
- (b) Enumerate factors affecting GI absorption of drugs. Explain theory of dissolution. (06)
- (c) Write a note on disintegrating agents. (05)
- (a) Write a note on Drug Interactions. (05)
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Date: 06-05-2019
Total Marks: 80
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