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Accelerated stability studies for moisture-induced aggregation of tetanus toxoid.
MedLine Citation:
PMID:  21072571     Owner:  NLM     Status:  In-Data-Review    
Abstract/OtherAbstract:
PURPOSE: The study was carried out to evaluate the effect of exposing solid tetanus toxoid to moisture in two different ways on the structure and function of the toxoid.
METHODS: Tetanus toxoid was exposed to moisture by (i) the addition of an optimized amount of buffer and (ii) incubation under an environment provided by a saturated solution of K(2)CrO(4.) The changes in the conformational, structural and antigenic properties of tetanus toxoid were measured and compared.
RESULTS: Results show that even at a similar level of moisture-induced aggregation, the amounts of water absorbed by the two preparations of tetanus toxoid are different. Differences in antigenicity and changes in structure of the toxoid at primary, secondary and tertiary structure levels were seen.
CONCLUSION: Although both conditions are used to mimic accelerated stability conditions in the laboratory, the final products are different in the two cases. Thus, conditions for 'accelerated stability studies' for therapeutic proteins need to be selected with care so that they resemble the fate of the actual product.
Authors:
Nishant Kumar Jain; Ipsita Roy
Publication Detail:
Type:  Journal Article     Date:  2010-11-12
Journal Detail:
Title:  Pharmaceutical research     Volume:  28     ISSN:  1573-904X     ISO Abbreviation:  Pharm. Res.     Publication Date:  2011 Mar 
Date Detail:
Created Date:  2011-02-17     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  8406521     Medline TA:  Pharm Res     Country:  United States    
Other Details:
Languages:  eng     Pagination:  626-39     Citation Subset:  IM    
Affiliation:
Department of Biotechnology, National Institute of Pharmaceutical Education & Research, Sector 67, S.A.S. Nagar, Punjab, 160062, India.
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