The Development of a Sustained and Controlled Release Device for Pharmaceutical Proteins based on Lipid Implants Fakultät für Chemie und Pharmazie - Digitale Hochschulschriften der LMU - Teil 01/06

The use of synthetic, biodegradable polymers is prevalently considered state-of-the-art in the development of controlled release systems for protein drugs. However, unveiled risks of protein inactivation during manufacturing and release represent a bottleneck in the final success of these systems over the last years. In this thesis, a sustained release implant device based on lipid materials for interferon alpha-2a (IFN alpha-2a) was developed, which provides high protein stability during implant preparation, storage, and drug release. Thus, the known problems of immune response associated with higher-order aggregate formation in proteinic drugs can be overcome. Adjustment of the lyophilisate formulation as well as of PEG and lipid qualities and quantities allow to control the release rate in order to realise the dosing schedule aimed for. Consequently, this device can be used as a very promising platform to deliver large pharmaceutical proteins for periods up to 1 month and even beyond.