Exam Details

Subject pharmaceutical formulation development and biopharmceutics
Paper
Exam / Course m.pharm
Department
Organization Gujarat Technological University
Position
Exam Date May, 2017
City, State gujarat, ahmedabad


Question Paper

Seat No.: Enrolment No.
GUJARAT TECHNOLOGICAL UNIVERSITY
M. Pharm SEMESTER- I • EXAMINATION SUMMER 2017
Subject Code: 910102 Date: 29/04/2017
Subject Name: Pharmaceutical Formulation Development and Biopharmceutics
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

Explain the method of Residuals for the estimation of Ka and KE.
06

Comment: Time to reach steady state drug plasma concentration is dependent on elimination half life and rate of infusion of the drug when drug is administered by IV Infusion.
05

IVIVC can be improved by selecting appropriate dissolution media, in-vitro dissolution set up and dosage form. Comment and elaborate.
05
Q.2

Explain: Discriminating media, Biorelavent media
06

What are CACO2 cell lines? Discuss merits, limitations and application of these cell lines.
05

Give the details of formulation and evaluation of face wash gel.
05
Q.3

Discuss the formulation and evaluation of herbal tablet containing papaya leaf extract, Gaduchi and Tulsi for the treatment of dengue.
06

Discuss physical factors influencing formulation
05

Explain: AUC, Loading Dose.
05
Q.4

Explain in detail solubility improvement of poorly soluble drugs using cosolvency and inclusion complex.
06

Give short note on "Organic Volatile Impurities".
05

Explain the pharmaceutical factors affecting drug absorption
05
Q.5

Discuss techniques for stabilization of product against the effect of various environmental factors.
06

Describe the methods to study bioavailability
05

What is ICH? Discuss different climatic zones in stability study
05
Q. 6

Write a note on Drug-Excipient compatibility study with examples.
06

Explain the importance of BCS classification in Pharmaceutical Dosage form formulation and development.
05

Discuss the methods to establish IVIVC
05
Q.7

Describe the dissolution apparatus for floating tablets and buccal tablets
08

Discuss the importance and application of solid state characterization in preformulation studies.
08



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Subjects

  • advanced medicinal chemistry
  • advanced organic chemistry-i
  • advanced organic chemistry-ii
  • advanced pharmacology ii
  • advanced pharmacology-i
  • advances in drug delivery system
  • advances in pharmacology
  • applied pharmacotherapeutics - ii
  • applied pharmacotherapeutics-i
  • audits and regulatory compliance
  • biological evaluations & clinical research
  • cellular and molecular pharmacology
  • clinical and hospital pharmacy
  • clinical pharmacy practice
  • clinical research and pharmacy practice
  • clinical research and regulatory affairs
  • clinical research regulations
  • cosmetic and cosmeceuticals
  • documentation and regulatory writing
  • drug design and discovery
  • drug regulation and regulatory authority
  • experimental design and patents
  • global regulatory requirements
  • gmp, glp and validation
  • good manufacturing and good laboratory practice
  • good manufacturing practice and process validation
  • good regulatory practices
  • hazards and safety management
  • industrial pharmacy practice
  • modern analytical techniques
  • modern pharmaceutical analysis
  • novel drug delivery system part-i
  • novel drug delivery system-ii
  • pharm. management -ii
  • pharmaceutical analysis ii
  • pharmaceutical and cosmetic analysis
  • pharmaceutical formulation and development
  • pharmaceutical formulation development and biopharmceutics
  • pharmaceutical manufacturing technology
  • pharmaceutical production management & technology
  • pharmaceutical regulatory affairs
  • pharmacological and toxicological screening methods-i
  • pharmacological and toxicological screening methods-ii
  • pharmacometrics and methods of biological evaluation of drugs
  • pharmacotherapeutics
  • principles of biopharmaceutics& pharmacokinetics
  • product development and technology transfer
  • quality control & quality assurance
  • quality control and quality assurance
  • quality management system
  • regulatory affairs - i
  • regulatory affairs and new drug applications
  • regulatory aspects of hebbal and biologicals
  • research methodology
  • validation and product development