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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, 1975
    PubMed
    Summary
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    See all related articles

    Researchers explored organic acids to create long-acting opioid antagonist formulations. Naltrexone zinc tannate and naltrexone aluminum tannate showed promising prolonged action and low toxicity in mice.

    Area of Science:

    • Pharmacology
    • Materials Science
    • Drug Delivery

    Background:

    • Opioid antagonists like naltrexone are crucial for managing opioid use disorder.
    • Developing long-acting injectable formulations can improve patient adherence and treatment efficacy.
    • Current formulations may have limitations in duration of action or require frequent administration.

    Purpose of the Study:

    • To investigate the formation of water-soluble and insoluble salts of opioid antagonists with various organic acids.
    • To develop and characterize drug:acid:metal complexes for sustained release applications.
    • To evaluate the in vitro dissociation and in vivo pharmacological activity of novel opioid antagonist preparations.

    Main Methods:

    • Screening of approximately 100 organic acids for salt formation with methadone, cyclazocine, naloxone, naltrexone, and diprenorphine.

    Related Experiment Videos

  • Formation and characterization of drug:acid:metal complexes using polyvalent metal ions (Zn++, Al+++, Mg++, Ca++).
  • Spectrophotometric analysis of drug and metal content, in vitro dissociation studies at pH 7.3, and in vivo efficacy testing (mouse tail-flick test).

    • Main Results:

    • About half of the tested organic acids formed insoluble salts with the opioid antagonists.
    • Optimized conditions for forming drug:acid:metal complexes with consistent composition were established.
    • Naltrexone zinc tannate and naltrexone aluminum tannate exhibited prolonged morphine antagonist activity in mice with no gross toxicity, and low in vitro dissociation.

    Conclusions:

    • Novel naltrexone complexes, specifically naltrexone zinc tannate and naltrexone aluminum tannate, demonstrate potential for long-acting injectable formulations.
    • These preparations show promising pharmacological profiles, including extended duration of action and low toxicity, making them candidates for clinical evaluation.
    • Suspensions in aluminum monostearate gel represent a useful dosage form for these novel opioid antagonist preparations.