Seat No.: Enrolment No.
GUJARAT TECHNOLOGICAL UNIVERSITY
M. Ph. SEMESTER I EXAMINATION SUMMER 2018
Subject Code: 910102 Date: 05/05/2018
Subject Name: PHARMACEUTICAL FORMULATION DEVELOPMENT
BIOPHARMACEUTICS
Time: 02:30PM TO 05:30PM 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 hydrotrophy with respect to solubilization.
06

Discuss drug excipients compatibility study in context to preformulation studies.
05

Discuss the importance of dissolution study and enlist various dissolution test apparatus as per IP and USP respectively.
05
Q.2

Explain biological half life and total body clearance in context to pharmacokinetic parameters.
06

Enumerate the pharmaceutical factors affecting drug absorption and discuss disintegration time in said context.
05

Write the objectives of stability study and enumerate the factors affecting stability of formulation.
05
Q.3

Discuss formulation of tooth paste.
06

Write a note on levels of IVIVC.
05

Discuss the rationale for selecting preferred polymorphs/crystalline form with respect to preformulation study.
05
Q.4

Write a note on compartment models.
06

Explain four classes of BCS.
05

Explain "Order of reaction". Define zero order reaction and first order reaction and write examples and equation for calculating half life for each.
05
Q.5

Enumerate the methods of studying bioavailability and with the help of diagram, explain the importance of three major parameters of urinary excretion data obtained with single dose study.
06

Write the criteria for obtaining valid urinary excretion data.
05

Define IVIVC and discus its purposes.
05
Q. 6

Define preformulation and write the objectives of preformulation studies.
Give full forms of the following: DSC XRD FTIR OVIs DTA and NCEs.
06

Write a note on photo stability testing.
05

Explain dissolution profile. Discuss the importance of comparison of the same and explain model independent method involving f1 and f2.
05
Q.7

Define shampoo and write its requirements. Enumerate shampoo additives.
06

Discuss the techniques for stabilization of pharmaceutical products against atmospheric oxygen.
05

Discuss hygroscopicity in context to preformulation study.
05