Opioid Overdose Reversal Products are Chemically Stable Well Past Expiration Date, Says Study

November 6, 2018
Pharmaceutical Technology Editors
Pharmaceutical Technology's In the Lab eNewsletter

Volume 13, Issue 12

Researchers evaluated the chemical stability of two different naloxone products administered to prevent opioid overdose deaths and found the products to have a significantly extended shelf life than previously known.

In a new study, “Evaluation of Chemical Stability of Naloxone Products Beyond Their Labeled Expiration Dates,” naloxone nasal spray (NNS) and naloxone injection (NIJ), otherwise known as Narcan and Evzio, which are administered to prevent opioid overdose deaths, were found to be chemically stable up for at least ten months and beyond one year of the expiration date, respectively. 

Researchers from the Marshall University School of Pharmacy and Appalachian College of Pharmacy evaluated the chemical stability of two different naloxone products, NNS-Narcan and NIJ-Evzio, past their labeled expiration dates, which currently have an 18-month to two-year shelf-life.

Both NNS and NIJ were kept at room temperature, simulating real-life storage, for six to 19 months past the labeled expiration dates. Using United States Pharmacopeia-adopted chromatographic methods, the researchers assessed the therapeutic content and degradation impurities of NNS and NIJ. The average potency of naloxone in NNS was 102.8% ±2.55 and NIJ was 105.98% ±1.25, both within the acceptance limit of 90%–100%.

“Naloxone has a short half-life which may result in healthcare and community providers carrying or storing outdated product,” said presenting author, Mohammad Faisal Hossain, B Pharm, M Pharm, PhD, instructor of pharmaceutical science at Appalachian College of Pharmacy, in a Nov. 6, 2018 press release. “What makes our research unique is that the products tested were unused expired doses from these local providers.”

The next stage of the research will be to conduct extensive longer-term (five-year) stability studies, such as microbiological stability, photo-stability, and chemical stability.

The study’s principal investigator Charles Babcock PharmD, certified diabetes educator, Board of Pharmacy Specialties Board Certified Ambulatory Care pharmacist (BCACP), assistant professor at Marshall University School of Pharmacy noted in the press release: “The country is experiencing an opioid epidemic and given the continued increase in opioid overdoses, our preliminary data suggests that extending the shelf life of these products should aid in avoiding the significant expense of replacing them every two years and also increase the availability of this life-saving medication in both stockpiles and communities.”

The study was presented on Tuesday, Nov. 6, 2018 at the 2018 American Association of Pharmaceutical Scientists PharmSci 360 Annual Meeting in Washington DC.

Source: AAPS