Gujarat Technological University 2010 M.Pharm Pharmaceutical Formulation, Development & Biopharmaceutics - Question Paper

Q.1 (a) What is Preformulation? How can it be characterized?
Comment: "Preformulation studies are limited to new drug
molecules only". Suggest various means to arrest hydrolysis of
APIs.
06
(b) How is the particle engineering influence the development of
compacted APIs and its compressed dosage form?
05
(c) describe polymorphism and pseudo-polymorphism.
Enlist the methods to identify polymorphism.
Comment on dissolution behavior and stability of polymorphs.
05
Q.2 (a) What do you mean by intrinsic solubility?
Enlist different solubilization techniques with their mechanisms.
explain the importance of B-cyclodextrin utility number and
derivation of it.
06
(b) explain the use of salt-formation, surfactants, adducts and clathrates
in solubilization of poorly soluble drugs.
05
(c) "Bioavailability of poorly soluble APIs is challenge to formulation
pharmacist". explain physical and chemical modification of APIs
and use of excipients to solve this problem.
05
Q.3 (a) What do you mean by dissolution mimicking?
Write a note on Biorelavant media.
06
(b) What is super critical fluid technique?
discuss its application in solubilization of APIs and compare its
efficiency with other such techniques.
05
(c) explain the dissolution test for unconventional and novel dosage
forms.
05
Q.4 (a) describe kinetics. define various methods to determine order of
reaction. Compare zero, 1st and 2nd order degradation with
emphasizing their utility in stability studies.
06
(b) explain the requirement related to stability testing with emphasizing
matrixing / bracketing technique, climatic zones, impurities and
photostabilization.
05
(c) How is accelerated stability study carried out?
How the outcomes of it can be correlated with real time study?
05
Q.5 (a) discuss the factors affecting gastric emptying. 06
How manufacturing variables affect drug absorption?
(b) describe bioavailability and bioequivalence.
Enlist methods of measurement of bioavalibility.
explain latin-square cross-over design.
05
(c) discuss schematic diagram of sequential absorption of oral solids.
elaborate the consideration of CACO2 cellline?
05
Q. six (a) describe biological half-life and quantity of distribution. How are they
related?
discuss the effect of drug distribution into tissue on Vd giving
suitable illustrations.
discuss the various routes of clearance.
06
(b) What is multi-compartment model?
Enlist such models and write a note on 3 compartment model.
05
(c) Write a note on non-linear pharmacokinetics. 05
Q.7 (a) describe IVIVC & IVIVR. elaborate the levels of correlation in
IVIVC? Suggest various methods and applications of it.
06
(b) compute the values of likeness and dissimilarity factors for the
subsequent data. (Time versus cumulative drug dissolved)
Time in min 10 20 30 45 60 90 120
Reference 33.7 51.02 62.38 70.95 79.66 89.89 90.81
Test 39.61 56.25 66.29 77.79 85.67 89.51 94.57
05
(c) explain the formulation of cosmetic product used in oral cavity. 05

Earning:   Approval pending.