Chemical stability of naloxone products beyond their labeled expiration dates.

Abstract

The purpose of this study was to evaluate the chemical stability of previously dispensed, expired naloxone products. When properly stored, certain products maintain stable, defined as within compendia acceptability, beyond their manufacturer's expiration date. Stockpiling life-saving medications such as the opioid overdose reversing agent naloxone nasal spray (NNS) or injection (NIJ) is of utmost importance to ensure public health emergency preparedness and response. Design/interventions/methods: After each naloxone product was stored at room temperature for several months (6-19) past their labeled expiration date, the level of active therapeutic content and the presence of degradation impurity, 2,29'-bisnaloxone, were evaluated via chromatographic separation with waters higher performance liquid chromatography integrated using the Waters X-Select CSHC-18. The effluent was detected at 229 nm. Active naloxone presence and the presence of degradation impurity, 2,29'-bisnaloxone, were evaluated. The mean potency of naloxone in both NNS and NIJ, up to 10 and 19 months post-expiration, respectively, is within the 90-110 percent United States Pharmacopeia acceptance limit (NNS: 102.8 ± 2.6 percent and NIJ: 106.0 ± 1.3 percent). No impurity was detected in any chromatogram of the expired products. In summary, since both NNS and NIJ were found to be chemically stable beyond 10 months of the expiration date, shelf-life extension of climate controlled, commercially available naloxone products should be further investigated as a potential cost savings measure for national strategic stockpiles, emergency medical services, hospitals, and public responders.