• David Shields, Rick Montenegro, and Jennifer Aclan.
• Elan Pharmaceuticals Inc., South San Francisco, CA, USA; Gilead Inc., Foster City, CA, USA.
• Neuromodulation. 2007 Oct 1;10 Suppl 1:1-5.

AbstractObjective.  To determine the stability of an admixture combining ziconotide with bupivacaine hydrochloride during simulated intrathecal infusion under laboratory conditions at 37°. Materials and Methods.  An admixture containing ziconotide (25 µg/mL) and bupivacaine hydrochloride (5 mg/mL) was stored in SynchroMed® II pumps at 37° and in control vials at either 37° or 5°. Using high-performance liquid chromatography, drug concentrations were determined from samples obtained at varying intervals during the 30-day study. Results.  After 30 days, pump ziconotide and bupivacaine hydrochloride concentrations measured an average of 86.9% and 99.4% of their initial concentrations, respectively. Control vials displayed similar degradation rates for both drugs. Statistical evaluation of the ziconotide 95% confidence interval indicated that the ziconotide concentration would meet or exceed 90% and 80% of initial concentration for 22 days and 45 days, respectively. Conclusions.  An admixture containing 25 µg/mL ziconotide and 5 mg/mL bupivacaine hydrochloride was 90% stable for 22 days and 80% stable for 45 days (extrapolated) in SynchroMed® II infusion pumps.

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