• Neuromodulation · Oct 2024

    Physicochemical Stability Study of the Morphine-Bupivacaine-Ziconotide Association.

    • Jeremy Sorrieul, Julien Robert, Auriane Blanchet, Julien Gouju, Florent Bienfait, Sabrina Jubier Hamon, Denis Dupoiron, and Catherine Devys.
    • Pharmacy, Institut de Cancérologie de l'Ouest Paul Papin, Angers, France. Electronic address: jeremy.sorrieul@ico.unicancer.fr.
    • Neuromodulation. 2024 Oct 1; 27 (7): 114911631149-1163.

    ObjectiveThe aim of this study was to investigate the physicochemical stability of morphine-bupivacaine-ziconotide mixtures used in intrathecal analgesia in polypropylene syringes and intrathecal pumps.Materials And MethodsThe stability study method was conceived according to International Council for Harmonisation guidelines. For propylene syringes, six different mixtures of morphine-bupivacaine and ziconotide were assessed over seven days. Two storage temperatures were tested (5 °C ± 3 °C and 25 °C ± 2 °C). For implantable pumps, nine different mixtures were assessed over 60 days and stored at 37 °C. Assays were performed using ultrahigh-pressure liquid chromatography. Turbidity and pH also were measured throughout the study.ResultsResults confirmed excellent physicochemical stability for morphine and bupivacaine in the study for all conditions investigated (pumps at 37 °C, polypropylene syringes at 5 °C ± 3 °C and 25 °C ± 2 °C). Concerning ziconotide, after seven days, our study showed that every 95% confidence interval calculated had lower bounds >90% for all mixtures stored in polypropylene syringes. In implantable pumps, a decrease of the concentration was observed in all the mixtures studied. Moreover, the appearance of a degradation product confirmed the ziconotide degradation.ConclusionAll results are in favor with a physicochemical stable preparation for six mixture profiles when stored in polypropylene syringes at 5 °C ± 3 °C and 25 °C ± 2 °C. For mixtures stored in implantable pumps, the efficacy should decrease over time owing to the degradation of ziconotide. A trade-off between high morphine concentration and increased refill interval will need to be found by clinicians.Copyright © 2023 International Neuromodulation Society. Published by Elsevier Inc. All rights reserved.

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