Purpose: Stockpiling life-saving medications is important to insure public health emergency preparedness and response. Expiration dates present challenges to stockpilers because products that have reached or surpassed their labeled expiration date are not recommended for use. Certain products, when properly stored, remain stable well beyond their labeled expiration date. Naloxone nasal spray (NNS – Narcan®) and naloxone injection (NIJ – Evzio®) have been widely used to reverse opioid overdose death. The purpose of this study was to evaluate the chemical stability of properly stored naloxone products beyond their labeled expiration dates in hopes to extend expiration dating and possibly eradicate both the necessity of replacing entire stockpiles every few years and the significant expense associated with replacement.
Methods: The naloxone products, obtained after expiration from individual terminal users, were maintained at room temperature for more than one year beyond their labeled expiration dates to evaluate the chemical stability for both impurities as well as active naloxone. The chromatographic methods used in this study to determine the content of naloxone and its impurity were adopted from USP. Chromatographic separation of naloxone and its impurity were achieved by Waters separation module integrated with a Waters X-Select CSH C-18 column. The peak purity of the sample chromatograms were obtained using Waters photodiode array detector.
Results: The average content of naloxone in NNS was 102.8% and NIJ were 104.55% to 106.0%, which are well within the acceptance limit of 90% to 110%. The acceptance limit for impurity is 4.0%; however, no impurity (2, 2′-bisnaloxone) was detected in the chromatograms.
Conclusion: Both NNS and NIJ were found to be chemically stable beyond one year after their expiration dates. In summary, our preliminary data suggests a shelf life extension of climate controlled commercially available naloxone products (NNS and NIJ). This should aid in avoiding the significant expense of replacing well controlled, room temperature stockpiles every few years. Additionally, this data could have profound impact on the consumer’s confidence to carry and utilize naloxone, if climate controlled, post expiration. Furthermore, monetary savings may translate into increased availability of this life-saving medication both in stockpiles and in communities.
Craig Kimble– Marshall University School of Pharmacy
Tiffany Davis– Marshall University School of Pharmacy
Randy Mullins– Appalachian College of Pharmacy
Mamoon Rashid– Appalachian College of Pharmacy
Sushanta Sarkar– Appalachian College of Pharmacy
Charles “CK” Babcock– Marshall University School of Pharmacy, West Virginia