Osmania University (OU) 2011-1st Sem M.Pharm acy (Pharm.Analysis& Quality Assurances/ Pharmaceutics/ Industrial Pharmacy)(Supplementary ) ember/ember - Question Paper

Subject: Pharmaceutical Product Development
Time: three Hours Max.Marks:70

Note : ans any 5 ques.. All ques. carry equal marks.

1. (a) List bulk characteristics to be learned in the preformulation of a new drug.Explain their
importance (10)
(b) discuss 1 method of determining drug excipient compatibilities with examples. (4)

2. (a) discuss the rationale in selecting surfactant in various dosage forms. (7)
(b) describe the term factorial design . define the application, advantages and disadvantages (7)

3. (a) define the phases involved in the determination of solubility of drugs. (8)
(b) discuss the complexation technique used for improving the solubility of drugs (6)

4. (a) define any 4 official methods of dissolution testing with tagged diagrams (10)
(b) discuss "sink" and "non-sink" condition to be maintained for dissolution (4)

5. (a) discuss 3 mechanism that affect the stability of drugs. suggested the preventive measures.
(b) define salient features of the accelerated stability testing of drugs. ( 9+5)

6. (a) define the influence of temperature on the rate of reaction with equations and graph ( 7)
(b) discuss Noyes-Whitney"s formula for the study of Dissolution of drugs (7)

7. (a) discuss the concept of Hydrotrophy with suitable examples.Explain the solubility method of analysis of the identical. (8)
(b) discuss the developments of new disintegrants and their utility in formulations. (6)

8. (a) define the characterization of crystallanity of substances by DSC. (7)
(b) define the ICH guidlines for stability testing. ( 7)

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Earning:   Approval pending.