Seat No.: Enrolment No.
GUJARAT TECHNOLOGICAL UNIVERSITY
B.PHARM- SEMESTER-VII • EXAMINATION WINTER-2016
Subject Code: 270001 Date: 17/11/2016
Subject Name: Dosage Form Design- I
Time: 10.30 am 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

Define polymorphism. Explain its importance in preformulation study with
example.
06

Write a brief note on overages.
05

Describe the Accelerated stability study with its limitation.
05
Q.2

Discuss Pharmaceutical application of Prodrug.
06

Discuss the role of diluents in solid dosage form.
05

Write a note on Preservatives.
05
Q.3

Explain the physicochemical properties of drug substance that affect the absorption of drug.
06

Write a note on volume of distribution.
05

Discuss the Photolysis reaction in detail.
05
Q.4

Discuss the factor affecting renal clearance.
06

Describe USP Type-II dissolution apparatus.
05

Write a note on BCS classification system.
05
Q.5

Discuss the effect of container and closures on stability of Pharmaceutical dosage form.
06

Explain Latin square cross over design in Bioequivalence study.
05

Discuss the criteria for waivers of in vivo Bioequivalence studies.
05
Q. 6

Write a note on Bracketing matrixing design in stability study.
06

Write a note on disintegrating agents.
05

Discuss the role of solubility in Preformulation study.
05
Q.7

Write a note on Plasma Protein Drug Binding.
06

Write a note on similarity factor and difference factor in dissolution profile comparison.
05

Discuss Drug-Excipients compatibility study in detail
05