Exam Details

Subject dosage form design- i
Paper
Exam / Course b.pharm
Department
Organization Gujarat Technological University
Position
Exam Date May, 2017
City, State gujarat, ahmedabad


Question Paper

Seat No.: Enrolment
GUJARAT TECHNOLOGICAL UNIVERSITY
B.PHARM.-SEMESTER-VII- EXAMINATION -SUMMER-2017
Subject Code: 270001 Date: 27/04/2017
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 effect of pKa of drug on absorption of drug from GIT at different pH.
06

Write a note on Polymorphism giving examples.
05

Explain mutual prodrugs. Describe the prodrug design for improvement of stability and bioavailability giving suitable examples.
05
Q.2

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

Define Mean Kinetic Temperature (MKT). Discuss different climatic zones for stability studies.
05

What are temperature and humidity requirements for performing stability study according to ICH guideline?
05
Q.3

Write brief note on factors affecting plasma protein binding.
06

Why overages are added in formulation? How it can be calculated?
05

Discuss physiological barriers for distribution of drugs.
05
Q.4

Define biopharmaceutics and give its role in dosage form desing.
06

Enumerate different types of transport mechanism. Explain active transport in detail.
05

Define gastric empting and explain factors affecting gastric empting.
05
Q.5

Write detail note on organoleptic additives.
06

Classify stabilizers and write their pharmaceutical applications.
05

Classify suspending agents. What are ideal characteristics of suspending agent?
05
Q. 6

Enlist methods of dissolution profile comparison Discuss in detail model independent method.
06

What is BCS? How BCS class of a drug is decided?
05

Define Intrinsic dissolution rate. Discuss factors affecting rate of dissolution.
05
Q.7

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

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

Differentiate absolute and relative bioavailability. What are the acceptance criteria for bioequivalence study?
05



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