Rajiv Gandhi University of Health Sciences
First Year M. Pharm Degree Examination – Nov 2011
[Time: 3 Hours] [Max. Marks: 100]
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FORMULATION TECHNOLOGY AND VALIDATION
PAPER II
(RS 2 & RS 3)
Q.P. CODE: 9292
Your answers should be specific to the questions asked.
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Draw neat labeled diagrams wherever necessary.
LONG ESSAY (Answer any TWO) 2 X 20 = 40 Marks
- Explain the validation of steam sterilization process
- Write a note on evaluation of plastic containers and rubber closures for injectable preparations
- What is stability testing? How is it performed and used for shelf life calculation
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SHORT ESSAY (Answer any FIVE) 5 X 10 = 50 Marks
- Explain solubility enhancement by co-solvent technique
- Write a note on solution stability
- Explain the evaluations of packing material for solid oral dosage form
- Define transdermal drug delivery systems. What are their advantages? How are they evaluated
- Write a note on organizing process validation
- Describe the formulation and evaluation of chewable tablets
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SHORT NOTES 2 X 5 = 10 Marks
- Draw a functional diagram of HVAC system for non-sterile dosage form manufacturing facility explaining each component
- Explain “selectivity” in analytical method validation as per IUPAC recommendation 2001.
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