The purpose of PHAY 0012 is to learn about the clinical importance of the formulation sciences and pharmaceutical processing. Clinically registered medicines will be used to exemplify concepts. To have impact, the formulation sciences requires knowledge of the clinical end point.

Pharmaceutical Biotechnology is covered during semester 1. Therapeutic proteins, polypeptides and vaccines have become widely, and in many cases routinely used since the advent of the biotechnology era (ca 1980). The vast majority of these medicines require parenteral administration. The non-covalent interactions of therapeutic proteins define a tertiary (3-dimensional) structure which must be maintained to be biologically active.

Maintaining the tertiary structure throughout the manufacture, formulation, transport, storage and use of therapeutic proteins is often difficult. Because parenteral administration is necessary, clearance is also often rapid and must be optimised. The pharmaceutical sciences are critical for transforming biotechnologically derived actives into viable and prac­tical medicines.

During Semester 2 we will examine other important facets of the formulation sciences. Complex formulations of low molecular weight actives or in some cases, actives that do not have a defined structure have been developed. Often these actives are poorly soluble, but one important consideration is these actives are often characterised by a narrow therapeutic window. Again the pharmaceutical sciences are critical in transforming such actives into useful medicines and while more traditional dosage forms continue to be developed, the use of drug eluting, implantable dosage forms, e.g. microspheres or injectable implants is also important to improve efficacy and patient compliance. During Semester 2 of the module there will be considerable emphasis on clinical pharmaceutics where clinically registered medicines will be used as examples to illustrate how the pharmaceutical sciences can influence clinical outcome. An emphasis of the importance of clinical pharmaceutics provides the framework to show how knowledge of the underlying science of medicines is important in the day-to-day provision and use of medicines. We will also discuss the development of generic medicines in the context of protein therapeutics, complex formulations and narrow therapeutic index drugs.

Another general topic of this module relates to how new medicines and treatments are evolving. There is much more awareness about the need to ensure there is widespread access for both improved versions of existing medicines and new medicines. The pharmaceutical sciences can contribute to the increased access of medicines by making medicines more cost-effective and more practical to use (e.g. provision of ready to use dosage forms, no need for a cold chain). The pharmaceutical sciences play an important part in the lifecycle management of medicines. Life cycle management seeks to increase patient benefit, often by developing an improved version of a medicine that may be easier to administer or has a longer duration of action. As exemplified in the coursework and in some of the lectures, the need to consider a holistic perspective about healthcare will be encouraged.