Course No 16587
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A lot of pharmaceutical products, cosmetics and food products are emulsions & gels. Regarding the production of pharmaceutical semi-solid preparations, the common GMP (Good Manufacturing Practice) concepts of validation and qualification have to be applied (i.e. EU GMP guidelines including Annex 9 and 15).
Semi-solid products have some characteristics that are different compared to other dosage forms (e.g. solid oral dosage forms). Due to the intrinsic effect of the vehicle and the influence of the formulation on the release of active ingredients (and the subsequent absorption), the final formulation (including packaging) should be defined early in the pharmaceutical development process. Comprehensive analytical, microbiological and stability testing contributes to that.
Additionally, since August 2013, important tools for the biopharmaceutical characterization of drug release are contained in the United States Pharmacopeia (USP) Chapter <1724> “Semisolid Drug Products – Performance Tests“.
Furthermore, rheology plays a significant role in the determination of a formulation’s flow properties (and for the characterization of semi-solid raw materials, like for example petrolatum, lanolin), during development, in-process-control (IPC), final end-product testing & release as well as in stability testing. The knowledge of rheological properties is essential for the production and filling of semi-solid preparations. Moving forward, the USP recently published two drafts for new USP Chapters <915> and <1912> regarding the characterization of viscoelastic properties of semi-solid preparations (Pharmacopeial Forum PF 43(2) [Mar.–Apr. 2017]).
These and other relevant topics will be presented and discussed in this training.
This training aims at explaining the pharmaceutical,
biopharmaceutical and technological aspects of
various semi-solid dosage forms for topical use.
Formulation concepts (including the use of emulsifiers and colloidal carrier systems), GMP aspects and the industrial manufacture/ filling of semi-solid formulations are clearly illustrated. The rheological characterization as well as microbiological and stability testing will be covered.
This course is directed at specialists and executives in research, development, production, quality control and quality assurance involved in the manufacturing, packaging, testing, release and authorization of pharmaceutical semisolids and cosmetic preparations.
Industrial manufacturing of semisolids – GMP aspects