Monash University Handbook 2011 Undergraduate - Unit

Refer to the specific census and withdrawal dates for the semester(s) in which this unit is offered.

Synopsis

This unit aims to equip students with fundamental and applied knowledge required to understand and assess pharmaceutical pre-formulation, formulation, sterilization and packaging of parenteral products, with special emphasis on drug product stability, including the kinetics and mechanisms of drug degradation and functional group reactivity. The unit is also designed to provide students with an understanding of aseptic processing, disinfection and preservation.

This will involve the study of:

• Preformulation/Formulation/ Containers and Closures
• Drug Stability
• Contamination control and sterilisation
• Biotechnology products

Objectives

At the end of this unit students will be able to:

1. Estimate rate constants, half-lives and shelf-lives for drug substances and products; Interpret pH-rate profiles for typical drugs and understand the main physicochemical properties that control chemical reaction rates.
2. Understand organic chemical reaction mechanisms for degradation of common drug functional groups; apply this knowledge to stabilization of drugs that are susceptible to hydrolysis, oxidation and photochemical degradation.
3. Understand basic features of drug inactivation by physical means.
4. Provide a summary of the necessary preformulation tools for new drug characterisation.
5. Given information on the bulk, physicochemical and stability properties of a drug, provide a clear strategy for the choice and development of a formulation of that drug.
6. Discuss the formulation of injections, including the purpose of all excipients used, and the general processes for the manufacture of injections including reconstitutable injections.
7. Discuss issues in the use of glass, plastic and rubber packaging materials.
8. Discuss contamination control and aseptic processing of sterile pharmaceuticals.
9. Describe sterilization processes, validation, sterility assurance and end product sterility testing.
10. Discuss microbial stability issues of pharmaceuticals and principles and practices of disinfection and preservation.
11. Appreciate the spectrum of disciplines involved in pharmaceutical biotechnology products.

Assessment

Final exam (2.5 hour): 80%; workshop assessments: 20%.

Chief examiner(s)

Dr Richard Prankerd

Contact hours

35 x 1hour lectures, 4 x 3hour workshops.

Prerequisites

PAC1211
PAC1222
PAC2232

Additional information on this unit is available from the faculty at:

http://www.monash.edu.au/muso/support/