The Development of a Sustained and Controlled Release Device for Pharmaceutical Proteins based on Lipid Implants

Mohl, Silke (2004): The Development of a Sustained and Controlled Release Device for Pharmaceutical Proteins based on Lipid Implants. Dissertation, LMU München: Fakultät für Chemie und Pharmazie

Abstract

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.

• Dokumententyp: Dissertationen (Dissertation, LMU München)
• Keywords: Protein release, Lipid implants, Polyethylene glycol, Protein stability
• Themengebiete: 500 Naturwissenschaften und Mathematik ; 500 Naturwissenschaften und Mathematik > 540 Chemie
• Fakultäten: Fakultät für Chemie und Pharmazie
• Sprache der Hochschulschrift: Englisch
• Datum der mündlichen Prüfung: 4. November 2004
• 1. Bericht­erstatter:in: Winter, Gerhard