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The effect of mannitol crystallization in mannitol-sucrose systems on LDH stability during freeze-drying.
MedLine Citation:
PMID:  22535541     Owner:  NLM     Status:  Publisher    
The objective of this study was to investigate the influence of mannitol crystallization and the effect of annealing on the stability of lactate dehydrogenase (LDH) during freeze-drying. For this purpose, protein formulations with different weight ratios of mannitol to sucrose were freeze-dried with and without annealing. Product crystallinity was calculated based on differential scanning calorimetry data. Protein stability was evaluated both functionally by measuring the activity recovery of the model protein LDH after freeze-drying, and structurally by analyzing the protein secondary structure. LDH showed lower stability in annealed samples, and a correlation could be established between the extent of product crystallinity and the stability of the model protein. The destabilizing effect of mannitol crystallization on LDH during freeze-drying can likely be attributed to removal of mannitol from the amorphous phase containing the protein. In addition, the formation of mannitol crystals seemed to enhance the interfacial denaturation of protein during freeze-drying. The use of 0.01% of Tween 80 in the formulation greatly improved the structural and functional stability of LDH against stresses induced by mannitol crystallization. © 2012 Wiley Periodicals, Inc. and the American Pharmacists Association J Pharm Sci.
Anas Al-Hussein; Henning Gieseler
Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2012-4-25
Journal Detail:
Title:  Journal of pharmaceutical sciences     Volume:  -     ISSN:  1520-6017     ISO Abbreviation:  -     Publication Date:  2012 Apr 
Date Detail:
Created Date:  2012-4-26     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  2985195R     Medline TA:  J Pharm Sci     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Copyright Information:
Copyright © 2012 Wiley Periodicals, Inc.
Division of Pharmaceutics, Freeze-Drying Focus Group, University of Erlangen, 91058 Erlangen, Germany.
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