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Thread: Naloxone products chemically stable past expiration date, study indicates

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    Needle Naloxone products chemically stable past expiration date, study indicates

    Opioid overdose reversal products chemically stable past expiration date, study indicates
    ScienceDaily
    November 6th, 2018

    A widely used 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. According to the National Institute on Drug Abuse, from 1996 to 2014, at least 26,500 opioid overdoses in the U.S. were reversed by laypersons using naloxone. The research, Evaluation of Chemical Stability of Naloxone Products Beyond Their Labeled Expiration Dates, was presented today at the 2018 American Association of Pharmaceutical Scientists (AAPS) PharmSci 360 Annual Meeting.

    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.

    "Naloxone has a short half-life which may result in healthcare and community providers carrying or storing outdated product," said presenting author, Mohammad Faisal Hossain, B.Pharm., M.Pharm., Ph.D., instructor of pharmaceutical science at Appalachian College of Pharmacy.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 NNS and NIJ were kept at room temperature, simulating real-life storage, for six-19 months past the labeled expiration dates. Using USP 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 percent +/-2.55 and NIJ was 105.98 percent +/- 1.25, both within the acceptance limit of 90 -- 100 percent.
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    They should already know the shelf life of the drug, why would they need a new study on this?

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    Quote Originally Posted by Captain.Heroin View Post
    They should already know the shelf life of the drug, why would they need a new study on this?
    You're right, the manufacturers probably knew this already, although it probably isn't something they make public. They, of course, set expiry dates conservatively and would not want to suggest in any way that the products might not need to be replaced as often, both for liability reasons and to sell more units.

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