Drug Delivery, Biotechnology & Validation Requirement

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DRUG DELIVERY, BIOTECHNOLOGY 2183601
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Code: 2183601 Credits: 7 Semester 8 Chem. Tech.

Drug Delivery, Biotechnology & Validation Requirement

Get the full GTU study material, English & Gujarati textbook PDFs, syllabus curriculum, and solved previous year question papers.

Drug Delivery, Biotechnology & Validation Requirement Syllabus — Unit-wise Content

The official GTU curriculum for Drug Delivery, Biotechnology & Validation Requirement (subject code 2183601) as prescribed for Chem. Tech. · Semester 8 divides the course into 3 units, covering 26 listed topics. The unit-wise breakdown below is read from the GTU syllabus document for this subject code, so you can check what the course actually covers before deciding which papers to attempt.

Download the official syllabus PDF (2183601)

Unit 1 Drug delivery system

20 lecture hours

  • Large scale manufacture and packing with focus on equipment with reference to Oral sustained and controlled release dosage forms
  • Aerosols Introduction to Novel drug Delivery Systems: Transdermal
  • Transmucosal (buccal
  • Colloidal: Liposome’s
  • emulsion systems etc Introduction to Radio pharmaceuticals
  • Overview of cosmetic products

Unit 2 Application of Biotechnology in foods, pharma

20 lecture hours

  • Application of Biotechnology in foods
  • pharma, and other industries with special reference to enzymes Definitions
  • nomenclature and terminologies
  • isolation purification strain improvements
  • optimization of growth and product formation using industrially important micro organism Genetic engineering principles and technique Principles of surface and solid state fermentation
  • Design of different fermentors and the biochemical engineering aspects
  • Process control of fermentations
  • Fermentation technology of industrial chemicals
  • organic acids
  • amino acids
  • antibiotics, etc
  • Enzyme fermentation and technology including immobilization and enzyme reactors
  • Fermentative animals, and other developments

Unit 3 Validation and Regulatory Requirements

20 lecture hours

  • CGMP and Quality assurance
  • Schedule M Process
  • product validation and quality audits
  • Documentation New drug application (NDA)
  • generic products(ANDA)
  • Schedule Y DPCO
  • drugs and cosmetics act and rules including licensing intermediates industry

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