BIOPRENG 4060 - Pharmaceutical Formulation and Manufacturing

The course informs about the dosage form design (formulation) of drugs. For this, an understanding of the biopharmaceutical pathway of the formulation and drug in the human body will be provided, from the entry (administration) to the exit (elimination); which governs drug absorption and bioavailability. This involves physical disintegration and dissolution processes in the gastrointestinal tract and the 'systemic transport' (blood circular system) up to membrane and cellular media transport. The course will provide detailed insight on the different classes of formulations, starting from how they are build up and finally how they are industrially manufactured. This involves explanation on the underlying fundamental physical and matter processes, with major focus on powder technology (e.g. flow, gliding, compression, granulation, drying, tabletting, coating). The manufacturing of tablets, as most common formulation product is described all the way up from the powders to the final product. This involves the principles of particle breaking, merging, dosing, mixing, flow, and more; as well as outlining the respective industrial equipment. Further, liquid formulations are presented, comprising (including lyophilisation for biopharmaceuticals), suspensions, and emulsions (supramolecular aggregates) as well as their preparation by mixing. The course presents various drug-delivery systems (e.g. coating, matrix, erosion, depot). The pre-formulation stage conducts analytical tests for essential functions, which formulations need to fulfil to be manufactured. Drug development will be described, including the stages from discovery (hit), to optimisation (lead), and testing (clinical phases) and legislation. Sustainability is achieved herein by the concepts of green chemistry, flow chemistry (continuous-flow), process intensification, and compact, modular container production platforms; the first being listed as Australia's frontier technology. The course is delivered through a combination of lectures (divided in a set of mini-lectures), training and exercises in a workshop, two assessments, and a quiz.