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Long-acting narcotic antagonist complexes

A P Gray, W J Guardina

    National Institute on Drug Abuse Research Monograph Series
    |January 1, 1976
    PubMed
    Summary
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    Researchers developed novel drug formulations for opioid antagonists like naltrexone. Naltrexone zinc tannate and naltrexone aluminum tannate show promise for extended duration of action with minimal toxicity.

    Area of Science:

    • Pharmacology
    • Materials Science

    Background:

    • Opioid antagonists are crucial for managing opioid overdose and addiction.
    • Developing long-acting formulations can improve patient compliance and treatment efficacy.

    Purpose of the Study:

    • To explore the formation of water-soluble salts and drug:acid:metal complexes of opioid antagonists.
    • To develop sustained-release formulations of narcotic antagonists with prolonged pharmacological action.

    Main Methods:

    • Screened nearly 100 organic acids for salt formation with methadone, cyclazocine, naloxone, naltrexone, and diprenorphine.
    • Investigated drug:acid:metal complexes using polyvalent metal ions (Zn++, Al+++, Mg++, Ca++).
    • Analyzed drug and metal content spectrophotometrically and assessed in vitro dissociation at pH 7.3.

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    Main Results:

    • Identified organic acids forming insoluble salts with opioid antagonists.
    • Developed and characterized drug:acid:metal complexes, establishing optimal conditions and consistent composition.
    • Naltrexone zinc tannate and naltrexone aluminum tannate demonstrated prolonged in vivo activity in mice (tail-flick test) with no gross toxicity.

    Conclusions:

    • Naltrexone zinc tannate and naltrexone aluminum tannate are promising candidates for extended-release opioid antagonist therapy.
    • Suspensions in aluminum monostearate gel represent a useful dosage form for these novel preparations.