Aims & Learning Objectives:
To demonstrate the need for aseptic processing, methods of validation and assessing technique. To show how solid dose medications and inhaled systems are formulated and to give a physical and chemical basis for the choice of particular formulated systems. On completing this unit, the student will demonstrate an understanding of the processes involved in generating solid dose pharmaceuticals and the various means of formulating such materials.
Content:
The need for aseptic processing, and the systems of work employed, including QA and QC. The students will be taught aseptic technique which will be assessed by broth fill and quantitative analysis of a CIVAS exercise. processing techniques common to the production of solid dose pharmaceuticals: milling, mixing, granulation and drying. The physics of tablet compaction. Direct compression tablet compaction. Formualtion of tablets for wet and dry granulation. Techniques of capsule production. Coating: sugar coating, polymer film coating and coatings for controlled release. Controlled release: physiological basis and need. Controlled oral release achieved by matrix, film coated and osmotic systems. Formulation of pMDI, DPI and nebulisable formulations.
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