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Extension of Tamiflu Shelf-Life in Strategic Stockpile for Public Health

Author(s): Keith DelMonte, Chau To, Kateryna Rashid, Mike Sayers, Michael Mendoza, Fang Zhao, Todd D Camenisch

Purpose: To determine whether stockpiles of expired Tamiflu in strategic national stockpiles are potent. Validation of drug stability and activity safeguards the public health to allow use of Tamiflu reserves during influenza outbreak.

Methods: USP method for oseltamivir phosphate was used to measure drug potency of stockpiled Tamiflu. Practical modifications to the dissolution method were used to evaluate the drug release./p>

Results: Chemical stability of three lots of expired Tamiflu indicated satisfactory drug potency meeting the USP acceptance criteria of the labeled claim. Dissolution testing showed that all Tamiflu lots passed the criteria of no less than 75% of labeled amount of drug dissolved. All samples analyzed had ~100% dissolution and chemical release attributes comparable to controls.

Conclusions: All expired lots of stockpiled Tamiflu tested were stable and potent based on USP guidelines. These stocks of Tamiflu could be authorized for use in response to influenza outbreak to protect the public health. This informs other local jurisdictions and health departments with an optimized protocol to validate additional stockpiled drug, and safeguard Tamiflu stocks by extending expiration dates as part of preparation strategies to protect the public health.

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