Subject Code: 2183601
GUJARAT TECHNOLOGICAL UNIVERSITY
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BE - SEMESTER-VII(NEW) EXAMINATION - SUMMER 2019
Date: 09/05/2019
Subject Name: Drug Delivery, Biotechnology & Validation Requirement
Time: 10:30 AM TO 01:00 PM
Instructions:
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- Attempt all questions.
- Make suitable assumptions wherever necessary.
- Figures to the right indicate full marks.
- (a) Write a note on “Liposome” MARKS 03
- (b) Discuss about Pre-formulation & the steps involved in the pre-formulation of sustained release drug delivery system. MARKS 04
- (c) Discuss about the role of agitators in Fermentation and list out the different types of agitators used in fermentation. Describe any two in detail. MARKS 07
- (a) Write a note on radiopharmaceuticals MARKS 03
- (b) What are the roles of restriction enzyme in recombinant DNA technology. Write a brief note on it. MARKS 04
- (c) Explain genetic engineering and the process involved in it. MARKS 07
- OR
- (a) Describe the components of aerosol system with a neat-labeled diagram MARKS 07
- (a) Discuss about New Drug Application and the types of data involved MARKS 03
- (b) Write in detail about Schedule-M guidelines for Process validation MARKS 04
- (c) Differentiate between solid state fermentation (SSF) & submerged liquid fermentation (SLF). MARKS 07
- OR
- (a) Write a note on “Drug Master File” MARKS 03
- (b) Discuss Transmucosal drug delivery system in detail. MARKS 04
- (c) What are the major components of Fermentation process? Discuss about them. MARKS 07
- (a) Define aerosols and explain its evaluation tests in detail MARKS 03
- (b) Describe the classifications & the components of the transdermal drug delivery system (TDDS). MARKS 04
- (c) Explain in-detail “Ophthalmic drug delivery system” MARKS 07
- OR
- (a) What are emulsions? Explain the role of emulsifying agent MARKS 03
- (b) Write a note on cosmetic products MARKS 04
- (c) Discuss sustained and controlled release dosage forms. Describe in detail about the material used for the sustained release drug delivery. MARKS 07
- (a) Write a note on how sterilization is effected in fermenter. MARKS 03
- (b) What is “DPCO”. Write a detailed note on it. MARKS 04
- (c) Describe Immobilized enzyme in detail. MARKS 07
- OR
- (a) Draw the basic design of fermenter. Label it properly. MARKS 03
- (b) Write notes on (1). Informed consent, (2). Ethics committee. MARKS 04
- (c) Describe NDA & ANDA in detail. MARKS 07
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Total Marks: 70
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