Scribd
Upload
95 views

2270001

This document appears to be an exam for a pharmaceutical course, asking students to answer questions about various topics related to dosage form design and drug development. The exam covers topics such as pharmacokinetics concepts like half-life and shelf-life; preformulation studies including solubility and polymorphism; drug transport mechanisms and factors affecting absorption; biopharmaceutics classification systems and concepts like bioavailability and bioequivalence; pharmaceutical excipients and adjuvants used in formulations; theories of dissolution; and issues around volunteer selection for bioavailability studies. The exam tests students' understanding of these essential concepts for designing drug dosage forms and assessing drug performance.

Uploaded by

vanita
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
95 views

2270001

This document appears to be an exam for a pharmaceutical course, asking students to answer questions about various topics related to dosage form design and drug development. The exam covers topics such as pharmacokinetics concepts like half-life and shelf-life; preformulation studies including solubility and polymorphism; drug transport mechanisms and factors affecting absorption; biopharmaceutics classification systems and concepts like bioavailability and bioequivalence; pharmaceutical excipients and adjuvants used in formulations; theories of dissolution; and issues around volunteer selection for bioavailability studies. The exam tests students' understanding of these essential concepts for designing drug dosage forms and assessing drug performance.

Uploaded by

vanita
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 1

Seat No.: ________ Enrolment No.

_________

GUJARAT TECHNOLOGICAL UNIVERSITY


BPHARM – SEMESTER VII • EXAMINATION – WINTER • 2016

Subject code: 2270001 Date: 17-11-2016


Subject Name: Dosage Form Design - I
Time: 10:30 am - 01:30 pm Total Marks: 70

Instructions:
1. Attempt all questions.
2. Make suitable assumptions wherever necessary.
3. Figures to the right indicate full marks.

Q-1
a. Define Half life, Self life and Overage. Discus about international climatic zones as per 06
ICH guideline
b. Discuss Matrixing and Bracketing Techniques: Purpose and objective. 05
c. Explain accelerated stability studies to find out shelf life with limitations as per ICH 05
guidelines.

Q-2
a. Define preformulation. Write a note on physicochemical properties related to solubility 06
study in preformulation.
b. Explain the role of polymorphism and crystallinity in Preformulation. Enlist the methods to 05
identify polymorphism.
c. What do you understand by prodrug? Give its applications for improving stability of drug. 05

Q-3
a. Enlist various mechanisms of drug transport. Discus active transport in detail. 06
b. Explain effect of pKa and pH on absorption parameter. 05
c. Short note on kinetics of Plasma protein binding. 05

Q-4
a. Writ full name BCS with its classification. Give its objective. Write factors affecting drug 06
dissolution with respect to test apparatus.
b. How the bioavailability of drug can be improved? 05
c. Write a note on similarity factor and dissimilarity factor. 05

Q-5
a. Define bioavailability and bioequivalence. Enlist methods of measurement of 06
bioavailability. Discuss latin-square cross-over design.
b. Enlist the chemical properties observed during preformulation study. Explain oxidation in 05
detail
c. Discuss criteria for waiver of in vivo bioavailability study with reference to drug product. 05

Q-6
a. Write a note on pharmaceutical excipients used as tablet binder and granulating agent. 06
b. Write a note on suspending agents and emulsifiers used in liquid formulations. 05
c. What do you understand by adjuvants? How are they utilized in designing innovative 05
dosage forms?

Q-7
a. Discuss the effect of containers and closures on stability of pharmaceuticals. 06
b. Enlist the theories of dissolution. Explain in detail Film Theory 05
c. Volunteer selection for bioavailability studies is a critical issue. Discuss the statement with 05
examples.
**********

You might also like