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Module QUALITY ASSURANCE, FORMULATION AND PROCESS DEVELOPMENT

Module code: CH314
Credits: 5
Semester: 1
Department: CHEMISTRY
International: Yes
Overview Overview
 

This module examines three important areas of pharmaceutical chemistry:
(i) Formulation of drug products. The course introduces the principles and purpose of formulating active pharmaceutical ingredients. The factors that must be considered in developing an effective formulation are considered and the role of drug delivery as part of the drug development process is discussed. Formulation of both small molecule and biopharmaceutical drugs will be examined.
(ii) Quality assurance aspects of the pharmaceutical process. The course covers the structure of the pharmaceutical industry and the factors that influence drug development and approval. Areas covered: Quality Assurance and Good Manufacturing Practice, Health and Safety in the pharmaceutical industry, The EPA and Environmental Regulations, and Recent Initiatives by the FDA.
(iii) Thermodynamics of Scale-up. Material covered includes a description of the important considerations in the scale up of any chemical reaction; differential scanning calorimetry (DSC) and the application of DSC in the analysis of pharmaceutical compounds; reaction calorimetry and the application of reaction calorimetry in the scale-up of chemical reactions.

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