PY8013 - TECHNOLOGY OF STERILE PRODUCTS (Syllabus) 2017-regulation Anna University

PY8013 - TECHNOLOGY OF STERILE PRODUCTS (Syllabus) 2017-regulation Anna University

PY8013

TECHNOLOGY OF STERILE PRODUCTS

 LPTC
3003

OBJECTIVE:
• To impart the knowledge of the various types and stages of process of sterile pharmaceutical products.

UNIT I

PARENTERALS

9
Introduction, historical perspective - parenteral routes of administration - formulation additives. Small volume parenterals - large volume parenterals.

UNIT II

STERILIZATION

9
Sterilization methods – Steam - Dry heat – Filtration – Gas - Ionizing radiation with their advantages and disadvantages. Validation of sterility. Particulate contamination.


UNIT III

INJECTIONS

9
Types of injections - aqueous and non- aqueous vehicles used for injection – manufacturing – packaging - labeling - storage of injections.

UNIT IV

PARENTERAL SUSPENSION AND EMULSION

9
Introduction – need for parenteral suspension and emulsion - manufacturing additives – formulation of parenteral suspension and emulsion – characterization – applications.

UNIT V

OPHTHALMIC PRODUCTS

9
Absorption of drugs in the eye - raw materials - ocular penetration enhancers - general safety consideration. Formulation of various ophthalmic products with their characterization.

TOTAL : 45 PERIODS

OUTCOMES:
• Able to understand the concepts of different types of sterile pharmaceutical formulations.
• Able to understand the sterilisation process for the sterile products.
• Understand the technology used for formulations of various sterile products.

TEXT BOOKS:
1. Loyd V. Allen, Howard C. Ansel, Pharmaceutical Dosage Forms and Drug Delivery Systems, 10thEdition, Wolters Kluwer Health 2013.
2. Roop K. Khar, SP. Vyas “Lachman/Liebermans: The Theory and Practice of Industrial Pharmacy”, 4th Edition CBS Publishers and Distributors 2013.

REFERENCES:
1. James Swarbrick “Encyclopedia of Pharmaceutical Science and Technology”,4th Edition, CRC Press 2012. 2. Sandeep Nema, Nema Sandeep, John D “Pharmaceutical Dosage Forms: Parenteral Medications”, 3rd Edition, Informa Healthcare 2010.
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