Seat No.: Enrolment No.
GUJARAT TECHNOLOGICAL UNIVERSITY
B.PHARM SEMESTER- 7 EXAMINATION SUMMER -2019
Subject Code: 270001 Date: 06-05-2019
Subject Name: Dosage Form Design- I
Time: 02:30 PM TO 05:30 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

Discuss the significance of solubility and dissolution on formulation, stability and bioavailability of dosage form.
06

Explain the physicochemical properties of drug substance that affect the absorption of drug.
05

What is therapeutic equivalence? Enlist various in-vivo and in-vitro approaches that can be utilized to establish bioequivalence.
05
Q.2

Write a note on Polymorphism giving examples.
06

Write a note on Improvement of stability and oral bioavailability using prodrugs.
05

What is BCS? Classify and give the significance of this system.
05
Q.3

Discuss different approaches for prevention of chemical degradation of pharmaceuticals.
06

Storage conditions for stability testing as per ICH guidelines.
05

Describe active transport and passive diffusion mechanism for absorption.
05
Q.4

Explain USP dissolution apparatus III, IV and V with diagram.
06

Write a note on suspending agents and emulsifiers used in liquid formulations.
05

Explain kinetic involved in protein drug binding with description of plots.
05
Q.5

Discuss bracketing and matrixing designs for stability testing of drug substances and drug products as per ICH guidelines.
06

Explain renal clearance.
05

Explain photodegradation and its prevention.
05
Q. 6

What are the objectives of bioavailability study? Explain measurement of bioavailability by Plasma level-time study.
06

Define Intrinsic dissolution rate. Discuss factors affecting rate of dissolution.
05

Write a brief note on overages.
05
Q.7

Enumerate factors affecting GI absorption of drugs. Explain theory of dissolution.
06

Write a note on disintegrating agents.
05

Write a note on Drug Interactions.
05