Chemical Stability of Admixtures Containing Ziconotide 25 mcg/mL and Morphine Sulfate 10 mg/mL or 20 mg/mL During Simulated Intrathecal Administration

Shields, David E; Aclan, Jennifer; Szatkowski, Aaron

Abstract

Chemical Stability of Admixtures Containing Ziconotide 25 mcg/mL and Morphine Sulfate 10 mg/mL or 20 mg/mL During Simulated Intrathecal Administration

Author(s): Shields David E, Aclan Jennifer, Szatkowski Aaron

Issue: Nov/Dec 2008 - Arthritis and Immunological Diseases

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Page(s): 553-557

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Abstract

The chemical stability of an intrathecally administered analgesic combination may influence the frequency of pump refills necessary to maintain safe and effective analgesia. Previous work has shown that the stability of ziconotide at body temperature is reduced substantially by the presence of morphine sulfate 35 mg/mL. The current study was performed to evaluate the chemical stability of admixtures combining ziconotide with lower concentrations of morphine sulfate during simulated intrathecal infusion under laboratory conditions at 37°C. Admixtures containing ziconotide 25 mcg/mL and morphine sulfate 10 mg/mL or 20 mg/mL were stored in implantable intrathecal pumps at 37°C and in control vials at 37°C or 5°C. Samples were obtained over 60 days (admixture containing morphine sulfate 10 mg/mL) or 28 days (admixture containing morphine sulfate 20 mg/mL) and drug concentrations were assessed by high-performance liquid chromatography. Estimates of the time intervals that each admixture retained =90% and =80% of t

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