Seat No.: Enrolment
GUJARAT TECHNOLOGICAL UNIVERSITY
M.PHARM SEMESTER EXAMINATION -WINTER 2018
Subject Code: 910102 Date: 03/01/2019
Subject Name: Pharmaceutical Formulation Development Biopharmaceutics
Time :10:30 AM TO 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

What is preformulation? Discuss importance of preformulation study.
06

Enumerate physicochemical factors influencing preformulation with suitable examples.
05

Discuss the role of crystallinity and polymorphism in dissolution of drug
05
Q.2

Enlist various techniques used for solubility enhancement. Discuss Solid dispersion in detail.
06

Discuss the applications of microcalorimetry in stability study.
05

Describe determination of bioavailability of drug using urinary excretion data.
05
Q.3

Describe significance of IVIVC. Explain methods of establishing IVIVC.
06

Define intrinsic solubility. Discuss a method to determine intrinsic solubility of a drug.
05

Write a note on drug excipients compatibility study.
05
Q.4

Discuss the permeability and active drug transport across CACO-2 monolayers
06

Enumerate types of bioequivalence. Discuss briefly latin-square cross over design.
05

Differentiate real time stability study and accelerated stability study.
05
Q.5

Discuss Physicochemical factors affecting the drug absorption.
06

Explain: Total Clearance, Volume of distribution.
05

Give the details of formulation and evaluation of herbal face wash.
05
Q. 6

Discuss matrixing and bracketing techniques for stability study design
06

What is BCS? Discuss the importance of BCS in dosage form development.
05

Discuss factors affecting on development of IVIVC.
05
Q.7

How dissolution medium is selected for new API? Explain discriminating and bio relevant dissolution media?
06

What is ICH? Discuss different climatic zones in stability study.
05

Explain formulation and evaluation methods of sunscreen lotions.
05