Extended shelf-life has potential for stockpiles and communities, say US researchers

A widely used naloxone nasal spray and naloxone injection, which are administered to prevent opioid overdose deaths, have been found to be chemically stable up for at least 10 months and beyond one year of the expiration date, respectively.

The nasal spray is currently not registered for use in Australia at this time, although it is being considered as an option.

Researchers from the Marshall University School of Pharmacy and Appalachian College of Pharmacy in the US evaluated the chemical stability of the nasal spray and injection past their labelled expiration dates, which currently have an 18-month to two-year shelf-life.

Their results were presented this week at the 2018 American Association of Pharmaceutical Scientists (AAPS) PharmSci 360 Annual Meeting.

“Naloxone has a short half-life which may result in healthcare and community providers carrying or storing outdated product,” said presenting author, Dr Mohammad Faisal Hossain (PhD), an instructor of pharmaceutical science at Appalachian College of Pharmacy.

“What makes our research unique is that the products tested were unused expired doses from these local providers.”

Both the nasal spray and injection solutions were kept at room temperature, simulating real-life storage, for six-19 months past the labelled expiration dates.

Using USP adopted chromatographic methods, the researchers assessed the therapeutic content and degradation impurities of the nasal spray and injections.

The average potency of naloxone in the nasal spray was 102.8% +/-2.55 and the injection was 105.98% +/- 1.25, both within the acceptance limit of 90-100%.

The study’s principal investigator Charles Babcock, assistant professor at Marshall University School of Pharmacy in the US, noted, “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 next stage of the research will be to conduct extensive longer-term (five years) stability studies such as microbiological stability, photo-stability, and chemical stability.

The American Association of Pharmaceutical Scientists (AAPS) is a professional, scientific organisation of
approximately 9,000 members employed in academia, industry, government, and other research institutes
worldwide.