Sie können Bookmarks mittels Listen verwalten, loggen Sie sich dafür bitte in Ihr SLUB Benutzerkonto ein.
Medientyp:
E-Book;
Hochschulschrift
Titel:
Entwicklung diskriminierender und bioprädiktiver Methoden zur Bestimmung der Wirkstofffreisetzung aus langwirksamen kontrazeptiven Darreichungsformen
In the last decades, the development of methods for drug release testing of different dosage forms has gained in importance. These methods are used for quality control and they can also be useful in early stage development of novel dosage forms. Today, biorelevant aspects are also included in methods for determining drug release of dosage forms. The implementation of biorelevant aspects can be a useful tool for predicting in vivo profiles based on results of in vitro drug release studies. Due to the increasing number of long-acting dosage forms on the market, there will be an increasing demand for accelerated drug release methods. One objective of this thesis was the development of discriminative and accelerated in vitro test methods for the determination of drug release from LNGB-containing injectable suspensions of different particle sizes. Based on the method to be developed, it should be possible to distinguish between the different particle sizes, which were in the range of 8-41 µm, despite acceleration of the method. In a first step, the saturation solubility of LNGB was determined in different dissolution media. Due to the poor solubility of LNGB in the investigated dissolution media, a varying amount of SDS (sodium dodecyl sulfate) was added to increase LNGB solubility in the respective media. For investigating drug release of the LNGB injectable suspensions, methods for USP apparatus II and for USP apparatus IV were developed. In a first set of experiments performed ...