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Enrolment No.
GUJARAT TECHNOLOGICAL UNIVERSITY
B. Pharm. - SEMESTER-7 EXAMINATION - SUMMER -2018
Subject Code: 270001 Date: 19/5/2018
Subject Name: Dosage Form Design- I
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Time: 02:30 PM TO 05:30 PM Total Marks: 80- Attempt any five questions.
- Make suitable assumptions wherever necessary.
- Figures to the right indicate full marks.
- (a) What is intrinsic solubility? How is it measured? 02
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(b) What is partition coefficient? What is its significance in preformulation? 04
(c) What is photolysis? Describe the means to prevent photodegradation of drugs. 05
(d) What is pro-prodrug? Describe the prodrug design approach for drug targeting with examples. 05 - (a) What are disintegrants? Name four superdisintegrants? 02
(b) What are ointments? Describe the different types of suppository bases. 04--- Content provided by FirstRanker.com ---
(c) Enumerate additives used in tablets. Discuss tablet binders. 05
(d) What is flavor? Describe flavors used in liquid formulations. 05 - (a) Define: Product Shelf Life and Mean Kinetic Temperature. 02
(b) What is formulation stability? Discuss the different climatic zones for stability testing. 04
(c) What are overages? How are they calculated? In which formulations are they allowed? 05--- Content provided by FirstRanker.com ---
(d) Describe matrixing and bracketing in stability study. 05 - (a) Explain: Drug Disposition and Dosage Form Design. 02
(b) What is protein drug binding? Describe displacement drug interactions in protein binding. 04
(c) What is drug transport? Describe passive diffusion process for drug transport. 05
(d) Describe the pH Partition theory for drug absorption. 05 - (a) What is GFR? Which are the markers used to measure it? 02
(b) Describe Latin Square cross over design for bioequivalence study. 04
(c) What is suprabioavailability? Describe AUC, Cmax and Tmax as bioavailability measures. 05
(d) What is absolute and relative bioavailability? Calculate these values for capsule based on given data. Capsule (Dose-200 mg Oral, AUC -40); Solution (Dose-200 mg Oral, AUC- 60) and Injection (Dose-100 mg IV bolus, AUC- 100). 05 - (a) Explain: Biowaivers. 02
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(b) What is BCS? What is its significance in dosage form design? 04
(c) What is biorelevant dissolution media? Name the USP dissolution apparatus with the use. 05
(d) What is dissolution efficiency? Describe dissolution data comparison based on f1 and f2. 05 - (a) What is ICH? Describe the ICH guidelines for stability. 04
(b) What is BBB? Describe approaches used to target polar drugs to brain. 04--- Content provided by FirstRanker.com ---
(c) Describe drug binding to HAS. 04
(d) What is sink condition? Describe methods to achieve in vitro sink condition. 04
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