PLEASE NOTE: This course has had a change of code - up to and including 2009 it was PHPH9111.

This course extends the principles covered in Pharmaceutical Development of Medicines (PHAR9102) and includes detailed review of the formulation and in vitro/in vivo assessment of oral controlled-release products and novel dosage forms such as transdermal therapeutic systems and osmotic pumps. There is an extensive chapter on the formulation and testing of inhaled medicines, including metered dose inhalers, dry powder inhalers and nebulisers and a chapter describing disperse formulations; the latter group includes emulsions, suspensions, ointments and creams.
Regulatory aspects of the quality and bioavailability of all of these products are discussed. The section on biological medicines expands on material delivered in PHAR9102, providing a detailed discussion of issues and considerations in the development of a range of biological medicines including those derived from natural and recombinant DNA sources and cellular and tissue therapies. Issues covered include appropriate sourcing of biological starting materials, choice of cell lines for the expression of recombinant products, handling of infectious and potentially infectious biological materials, product characterisation, and storage and regulatory issues.

Note: The course is elective for programme 9060.