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. 2020 Oct;23(7):1034-1041.
doi: 10.1111/ner.13218. Epub 2020 Jul 6.

Study of Physicochemical Stability of Ziconotide in Medication Cassette Reservoir

Julien Robert  1 , Jeremy Sorrieul  1 , Amelie Andrieu  1 , Freddy Mounsef  2 , Denis Dupoiron  3 , Catherine Devys  1
Affiliations

Study of Physicochemical Stability of Ziconotide in Medication Cassette Reservoir

Julien Robert et al. Neuromodulation. 2020 Oct.

Abstract

Objective: To determine the physicochemical stability of ziconotide solutions for intrathecal administration in the Medication Cassette Reservoir (MCR).

Materials and methods: A stability indicating UPLC-DAD method was developed and validated according to the ICH guidelines. Two mixtures of ziconotide (0.40 μg/mL and 0.60 μg/mL) stored in MCR stored at 25 ± 2°C were evaluated for 14 days and compared to the initial observed concentrations.

Results: The physicochemical stability of the two solutions was demonstrated for two days thanks to relative concentrations, pH measurement, visual inspections, and turbidity assays. A degradation product was observed and increased during the study.

Conclusion: This study showed a very low physicochemical stability of diluted ziconotide stored at 25 ± 2°C in the MCR. The intrathecal administration of ziconotide does not seem appropriate with this device for outpatients.

Keywords: ICH; UPLC DAD; medication cassette reservoir; stability-indicating method; ziconotide.

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References

REFERENCES

    1. Bennett G, Serafini M, Burchiel K et al. Evidence-based review of the literature on intrathecal delivery of pain medication. J Pain Symptom Manage 2000;20:S12-36.
    1. Deer TR, Smith HS, Burton AW et al. Comprehensive consensus based guidelines on intrathecal drug delivery systems in the treatment of pain caused by cancer pain. Pain Physician 2011;14:E283-312.
    1. Bhatia G, Lau ME, Koury KM et al. Intrathecal drug delivery (ITDD) systems for cancer pain. F1000Research 2014;2 :2.
    1. Bottros M, Christo P. Current perspectives on intrathecal drug delivery. J Pain Res 2014;7.615-626.
    1. Staats PS, Yearwood T, Charapata SG et al. Intrathecal ziconotide in the treatment of refractory pain in patients with cancer or AIDS: a randomized controlled trial. JAMA 2004;291:63-70.

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