BP814TT (1) - 230525 - 071753

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Seat No.: _____ Enrolment No.

_____________

GUJARAT TECHNOLOGICAL UNIVERSITY


B.PHARM - SEMESTER–VIII EXAMINATION – WINTER -2022

Subject Code:BP814TT Date: 23/12/2022


Subject Name: Pharmaceutical Product Development
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 (a) Describe Pharmaceutical Product development process with flow chart. 06
(b) Classify types of solublizers. Discuss in detail about the different 05
pharmaceutical solublizers available in market.
(c) Write a note on stability assessment of semisolid dosage form. 05
Q.2 (a) Discuss quality control test of capsule dosage form. 06
(b) Explain in brief about excipients used for cream. 05
(c) Write a note on Emulsifying agent. 05
Q.3 (a) Enumerate different types of disintegrant. Discuss in brief about 06
Superdisintegrant.
(b) What is QbD? Describe advantages and challenges of QbD approach. 05
(c) Enumerate different types of packaging materials. Discuss glass as a packaging 05
material.
Q.4 (a) Enumerate ideal requirements of excipients used for Aerosol. Discuss about 06
Propellant.
(b) Describe properties, types and applications of Cyclodextrins. 05
(c) Discuss use and applications of factorial design in product development. 05
Q.5 (a) Classify types of excients used in tablet. Explain Diluents and Binder. 06
(b) Discuss selection criteria and quality control test of plastic as a packaging 05
material.
(c) Write a note on Polyethylene glycols and Sorbitol’s. 05
Q. 6 (a) Classify type of closures. Discuss quality control test of closures. 06
(b) Write a note on Enteric and Non Enteric coating excipients. 05
(c) Describe criteria for selection of excipients for parenteral dosage form. 05
Q.7 (a) Describe objectives of optimization techniques in Product development. 06
Explain various parameters of optimization techniques.
(b) Enlist directly compressible excipients. Explain any two in detail. 05
(c) Write a note on excipients used for formulation of NDDS. 05

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