Preformulation studies of Clostridium difficile toxoids A and B.

Preformulation studies of Clostridium difficile toxoids A and B. Research Abstract Details 

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Preformulation studies of Clostridium difficile toxoids A and B. Abstract Text:

To enhance the physical stability of Clostridium difficile toxoids A and B, screening for stabilizing compounds was performed. The screening of 30 GRAS compounds at various concentrations and in several combinations was performed in two parts. First, a high-throughput aggregation assay was used to screen for compounds which delayed or prevented aggregation of toxoids under stress conditions (toxoids at pH 5-5.5 were incubated at 55 degrees C for 55 or 75 min). Compounds which stabilized both proteins were further studied for their ability to delay unfolding under conditions leading to a presumably native-like folded state (pH 6.5). The thermal stability of the toxoids on the surface of Alhydrogel(R) was monitored with DSC and also showed significant improvement in the presence of certain excipients. This study has generated information concerning the free and adjuvant bound toxoids behavior under a range of conditions (temperature, solutes) that can be used to design pharmaceutical formulations of enhanced physical stability. (c) 2008 Wiley-Liss, Inc. and the American Pharmacists Association J Pharm Sci 97:4194-4207, 2008.

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Preformulation studies of Clostridium difficile toxoids A and B. Journal Published:

PUBLICATION TYPE: Journal Article

Journal: Journal of pharmaceutical sciences

VOLUME: 97

Page Numbers: 4194-207

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ISSN: 1520-6017

DAY: 3

MONTH: Oct

YEAR: 2008

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LANGUAGE: eng

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Grant and Affiliation Information for Preformulation studies of Clostridium difficile toxoids A and B.

AFFILIATION: Department of Pharmaceutical Chemistry, University of Kansas, Lawrence, Kansas 66047.

Country: United States

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MEDLINETA: J Pharm Sci

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