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Mikro- und Nanoarzneiformen in Formulierung und Qualitätskontrolle. Teil 2

Welche Methoden eignen sich für den Test auf Wirkstofffreisetzung?
Micro and nanoformulations in development and quality control: Which methods are suitable for drug release testing?
: Nothnagel, L.; Wacker, M.G.

Die Pharmazeutische Industrie 80 (2018), Nr.10, S.1418-1422
ISSN: 0031-711X
ISSN: 1616-7074
Fraunhofer IME ()

A rising number of nanopharmaceuticals have shown the potential of nanotechnology in the formulation of poorly soluble drugs as well as in the reduction of side effect of highly potent Active Pharmaceutical Ingredients (APIs). Despite steady progress, only few in vitro techniques enable prediction of the in vivo performance of nanotherapeutics. In addition, no uniform guidelines for the drug release testing of nanopharmaceutical dosage forms during development and quality control are established. In the following, approaches for investigating drug release from nanotherapeutics are discussed. A variety of techniques is available ranging from dialysis-based methods to sample and separate techniques, most of which provide a physiologically relevant setup to support formulation development and quality control.