Seat No.: Enrolment
GUJARAT TECHNOLOGICAL UNIVERSITY
B.Pharm SEMESTER VII EXAMINATION WINTER 2017
Subject code: 270001 Date: 02-11-2017
Subject Name: Dosage Form Design- I
Time: 10:30 am to 01:30 pm Total Marks: 80
Instructions:
1. Attempt any five questions.
2. Make suitable assumptions wherever necessary.
3. Figures to the right indicate full marks.
Q.1

Define Preformulation. Enumerate outline of the principle areas of prefromulation research. Discuss in details about bulk characterization in preformulation.
06

Discuss the significance of solubility and dissolution on formulation, stability and bioavailability of dosage form.
05

Define polymorphism. Give their types. Discuss the importance of polymorphism in preformulation.
05
Q.2

Write a note on Improvement of stability and oral bioavailability using prodrugs.
06

Explain following terms for preformulation drug characterization: Hydrolysis, Oxidation, Photolysis, pH, Excipient compatibility
05

Discuss the methods to ascertain the order of a reaction.
05
Q.3

Give significance of any two with suitable examples:
Antioxidants, preservatives, colouring agents, flavoring agents
06

Enumerate excipients used in solid dosage form. Discuss diluents and binders in details.
05

Write a short note on suspending agents and emulsifiers with examples.
05
Q.4

Write a short note on Accelerated Stability Studies.
06

Discuss bracketing and matrixing designs for stability testing of drug substances and drug products as per ICH guidelines.
05

Explain shelf life and overages? Describe calculation of overages.
05
Q.5

Enumerate the mechanisms of drug absorption. Discuss passive diffusion in detail.
06

Enumerate factors affecting GI absorption of a drug from its dosage form.
05

Enumerate Physiologic barriers to drug distribution in the body. Explain Blood Brain barrier in detail.
05
Q. 6

Define Bioavailability. What are objectives of Bioavailability studies? Enumerate the factors affecting Bioavailability of a drug from its dosage form.
06

Describe Type I dissolution apparatus with a labeled diagram.
05

Discuss the factors affecting renal excretion of drugs.
05
Q. 7

Write a short note on pharmacokinetic methods to measures bioavailability.
06

Enumerate factors influencing the drug dissolution that are related to physicochemical properties of drugs. Explain any two in details.
05

Give equations of similarity factor and dissimilarity factor for Dissolution profile comparison.
05