Mikro- und Nanoarzneiformen in Formulierung und Qualitätskontrolle
Welche Methoden eignen sich für den Test auf Wirkstofffreisetzung? – Teil 1
Übersichten
Key WordsFreisetzung | Dissolution | Nano | Dialyse | Sample and Separate
Abstract
Micro and nanoformulations in development and quality control: Which methods are suitable for drug release testing?
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.
Korrespondenz:
Dr. Matthias G. Wacker, Fraunhofer-Institut für Molekularbiologie und Angewandte Ökologie (IME), Translationale Medizin und Pharmakologie (TMP), Pharmazeutische Technologie und Nanowissenschaften, Max-von-Laue-Str. 9, 60438 Frankfurt am Main, Germany; e-mail: matthias.wacker@ime.fraunhofer.de
Zusammenfassung
Eine steigende Zahl zugelassener Nanoarzneiformen beweist das Potenzial in der
