Journal
INTERNATIONAL JOURNAL OF PHARMACEUTICS
Volume 414, Issue 1-2, Pages 140-147Publisher
ELSEVIER
DOI: 10.1016/j.ijpharm.2011.05.022
Keywords
Adjuvant; Aluminium hydroxide; Cryoprotectant; Tetanus toxoid
Categories
Funding
- Department of Biotechnology (Govt. of India)
- Council for Scientific and Industrial Research (Govt. of India)
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Exposure to subzero temperature leads to loss of vaccine potency. This can happen due to degradation of adjuvant surface and/or inactivation of the antigen. When adsorbed on aluminium hydroxide and subjected to freeze-thawing, tetanus toxoid was desorbed from the gel matrix and the preparation was found to lose its antigenicity. Analyses showed that the gel particles were denatured after freezing. When freeze-thawing was carried out in the presence of glucose, sorbitol and arginine, the degradation of gel particles was inhibited. A higher fraction of the protein could be retained on the gel. However, the antigenicity of these preparations was quite low. In the presence of trehalose, the protein could be partially retained on aluminium hydroxide. Being a cryoprotectant, trehalose was also able to inhibit the freezing-induced denaturation of tetanus toxoid, which resulted in retention of antigenicity of the adjuvanted toxoid. (C) 2011 Elsevier B.V. All rights reserved.
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