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Paper Id: 2 3 1 0 5 3 Roll No.
(SEM VIII) THEORY EXAMINATION 2022-23
PHARMACEUTICAL PRODUCT DEVELOPMENT
Time: 3 Hours Total Marks: 75
Note: Attempt all Sections.
1. Attempt all questions in brief. 2 x 10 = 20
(a) What do you understand about the term ‘IPQC’?
(b) Give the classification of non-ionic surfactant.
(c) What is dissociation constant?
(d) Give any two examples of excipients specially used in semi solid dosage form.
(e) Define directly compressible vehicle with example.
(f) Define QbD.
(g) Write about LAL test.
(h) What is film forming agent used in coating technology?
(i) Define propellants used in aerosols.
(j) Define optimization.
2. Attempt any two parts of the following: 10 x 2 = 20
(a) What are Preformulation SQtuP23
dies? Why these are important in development of new
pharmaceutical products? Discuss objectives and regulations related to preformulation.
(b) Discuss the selection, quality control and regulatory considerations of packaging materials
used for pharmaceutical preparations.
(c) What are the roles of pharmaceutical excipients in the development of pharmaceutical
product in context of cyclodextrins? Write the applications of cyclodextrin.
3. Attempt any five parts of the following: 7 x 5 = 35
a. What is pharmaceutical product development? Give the objectives of pharmaceutical product
development in details.
b. Explain various elements of QbD.
c. Explain factorial design with example.
d. Explain Non – ionic surfactants an d| 0
their applications as emulsifier.
e. What do you mean by NDDS? Discuss in detail about various excipients used in the
formulation of NDDS.
f. What are Coat materials? Describe the various excipients used in the formulation of tablets and
g. Write about the glass packaging material for pharmaceutical product development.
QP23DP1_290 | 06-01-2023 08:56:01 | 126.96.36.199