PAC3252 - Drug delivery II

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.