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Health Sciences
First Semester M. Pharmacy Degree Examination
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[Time: 3 Hours] [Max. Marks: 75]
Pharmaceutical Formulation Development
Q.P. CODE: 5109
Your answers should be specific to the questions asked.
Draw neat, labeled diagrams wherever necessary.
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LONG ESSAY (Answer any Three) 3 X 10 = 30 Marks
- Describe in detail the preformulation studies to be conducted for the development of a semi-solid dosage form.
- Describe the importance of factorial design and models for the process development studies with relevant examples.
- Explain in detail the various techniques of improving the drug solubility.
- Define dissolution. Explain in detail the theories of dissolution.
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SHORT ESSAY (Answer any Nine) 9 X 5 = 45 Marks
- Discuss the structure modifications of drug substances in view of preformulation studies.
- Explain the formulation development of any solid dosage form.
- Describe the importance of formulation additives with respect to liquid dosage form development.
- Explain experimental method to determine the solubility of drug substances.
- Describe the significance of accelerated stability studies.
- Explain solution stability of drugs.
- Describe ICH guideline for stability testing.
- Explain data handling of dissolution studies of controlled release dosage forms.
- List out the various dissolution testing apparatus. Explain any two official dissolution testing apparatus.
- Mention the different techniques of Drug-excipient compatibility studies. Explain in detail any one.
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