Characterization of Protein and Peptide Stability and Solubility in Non-Aqueous Solvents

Author: Stevenson C.L.

Source: Current Pharmaceutical Biotechnology, Volume 1, Number 2, September 2000 , pp. 165-182(18)

Publisher: Bentham Science Publishers

Abstract:

Small molecule parenterals have often been formulated as solutions or suspensions in non-aqueous conditions, however, this technology has not found widespread use in the formulation of macromolecules. Formulation of proteins and peptides has primarily been achieved through aqueous solutions or reconstituted lyophilized cakes. The incorporation of non-aqueous techniques has been limited by the lack of general applicability. For example, prediction of solubility, chemical stability, conformational stability (unfolding/denaturation processes), and activity can be difficult. Therefore, macromolecule non-aqueous preformulation work must be performed on a case by case basis. In addition, only a few solvents are pharmaceutically acceptable. This article reviews the characterization of proteins and peptides in a variety of non-aqueous or co-solvent conditions (both acceptable and unacceptable for pharmaceutical applications), and discusses the applicability of non-aqueous conditions for increasing solubility, stability and activity.

Keywords: Protein; Peptide stability; Solubility; BSA; Glucagon; Insulin

Language: English

Document Type: Review article

DOI: http://dx.doi.org/10.2174/1389201003378942

Publication date: 2000-09-01

• Current Pharmaceutical Biotechnology aims to cover all the latest and outstanding developments in Pharmaceutical Biotechnology. Each issue of the journal contains a series of timely in-depth reviews written by leaders in the field covering a range of current topics in both pre-clinical and clinical areas of Pharmaceutical Biotechnology. Current Pharmaceutical Biotechnology is an essential journal for academic, clinical, government and pharmaceutical scientists who wish to be kept informed and up-to-date with the latest and most important developments.

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• In this Subject: Nutrition & Food ,  Biotechnology ,  Pharmacology
• By this author: Stevenson C.L.

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