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Stability of mitomycin admixtures.

E J Quebbeman, N E Hoffman, R K Ausman

    American Journal of Hospital Pharmacy
    |August 1, 1985
    PubMed
    Summary
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    Mitomycin stability for intravenous infusion is enhanced by buffering. Buffered mitomycin in dextrose solution remains stable for 15 days at room temperature and 120 days refrigerated, unlike unbuffered solutions.

    Area of Science:

    • Pharmaceutical Sciences
    • Drug Stability Studies
    • Intravenous Infusion Formulations

    Background:

    • Continuous intravenous infusion requires stable drug formulations.
    • Mitomycin stability in common intravenous admixtures is not well-established.
    • Understanding mitomycin stability is crucial for safe and effective administration.

    Purpose of the Study:

    • To evaluate the stability of mitomycin in admixtures for continuous intravenous infusion.
    • To determine the impact of buffering and storage conditions on mitomycin stability.
    • To provide guidelines for the preparation and storage of mitomycin infusions.

    Main Methods:

    • Mitomycin was reconstituted and diluted in 5% dextrose or 0.9% sodium chloride injections.
    • Admixtures were prepared with or without a phosphate buffer solution.

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  • Stability was assessed by HPLC, UV spectroscopy, visual inspection, and pH testing under various storage conditions (room temperature and refrigeration) for up to 120 days.

    • Main Results:

    • Unbuffered mitomycin admixtures showed rapid degradation, with less than 26% remaining after 12 hours at room temperature in dextrose.
    • Refrigeration slowed degradation of unbuffered admixtures, but significant loss was still observed within 24 hours.
    • Buffered mitomycin admixtures demonstrated excellent stability, with minimal degradation (<10%) over 120 days at 5°C and up to 15 days at room temperature (27-30°C).

    Conclusions:

    • Buffering mitomycin to a pH of approximately 7.8 significantly enhances its stability in 5% dextrose injection.
    • Buffered mitomycin admixtures are suitable for prolonged storage and administration via continuous intravenous infusion.
    • Unbuffered mitomycin admixtures are unstable and should not be used for prolonged infusions.