PMID: 9160367Jan 1, 1997Paper

Protein delivery from biodegradable microspheres

Pharmaceutical Biotechnology
J L Cleland

Abstract

The key components to the successful development of a biodegradable microsphere formulation for the delivery of proteins are polymer chemistry, engineering, and protein stability. These areas are intricately related and require a thorough investigation prior to embarking on the encapsulation of proteins. While each of these components is important for the development of a biodegradable microsphere formulation for protein delivery, other critical issues should also be considered. In particular, preclinical studies in the appropriate animal model are usually necessary to assess the potential feasibility of a continuous-release dosage form. These studies should be performed at the earliest possible stage of development to validate the feasibility of a controlled release formulation. After the utility of a controlled release formulation has been demonstrated, the polymer matrix should be chosen and bench-scale production of microspheres initiated. The only polymers presently approved for human use for controlled delivery are the polylactides [poly(lactic acid), poly(glycolic acid), and poly(lactic-coglycolic) acid]. These polymers require multiphase processes involving several steps to produce microspheres containing the desired pr...Continue Reading

Citations

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