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Current Pharmaceutical Biotechnology

Editor-in-Chief

ISSN (Print): 1389-2010
ISSN (Online): 1873-4316

The Stability Factor: Importance in Formulation Development

Author(s): Rajesh Krishnamurthy and Mark C. Manning

Volume 3, Issue 4, 2002

Page: [361 - 371] Pages: 11

DOI: 10.2174/1389201023378229

Price: $65

Abstract

Efficient development of stable formulations of protein pharmaceuticals requires an intimate knowledge of the protein and its chemical and physical properties. In particular, understanding the mechanisms by which a protein could degrade is critical for designing and testing formulations. This review describes the major pathways by which proteins can degrade, including denaturation, aggregation, oxidation, and interfacial damage. The methods to detect the degradation are covered, along with generalized strategies to retard or prevent each type of decomposition. Without an appreciation of the current best practices for devising stable formulations, the formulation process will be neither efficient nor optimal.

Keywords: Protein, Hydrophobic Interactions, Fluorescence Spectroscopy


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