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Accelerated Stability Studies for Moisture-Induced Aggregation of Tetanus Toxoid

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ABSTRACT

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 K2CrO4. 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.

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ACKNOWLEDGMENTS

Partial financial support received from Department of Biotechnology (Gov’t of India) is gratefully acknowledged. NKJ acknowledges the grant of senior research fellowship from Council for Scientific and Industrial Research (Gov’t of India). The authors thank Mr. Dinesh Kumar for recording the scanning electron micrographs.

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  1. Department of Biotechnology, National Institute of Pharmaceutical Education & Research, Sector 67, S.A.S. Nagar, Punjab, 160062, India

    Nishant Kumar Jain & Ipsita Roy

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  1. Nishant Kumar Jain
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  2. Ipsita Roy
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Correspondence to Ipsita Roy.

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Jain, N.K., Roy, I. Accelerated Stability Studies for Moisture-Induced Aggregation of Tetanus Toxoid. Pharm Res 28, 626–639 (2011). https://doi.org/10.1007/s11095-010-0316-2

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  • DOI: https://doi.org/10.1007/s11095-010-0316-2

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