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Stability and Compatibility of Reconstituted Caspofungin in Select Elastomeric Infusion Device

Author(s):  Tsiouris Maria, Ulmer Marisa, Yurcho James F, Hooper Kevin L, Gui Min

Issue:  Sep/Oct 2010 - Supporting Quality Pharmaceutical Compounding World Wide
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Abstract:  The stability and compatibility of caspofungin acetate reconstituted in 0.9% sodium chloride injection was studied in select elastomeric infusion devices. Caspofungin acetate solutions at three different concentrations, 0.2, 0.28, and 0.5 mg/mL, were stored in three commonly used elastomeric infusion devices at 5°C ± 3°C and at room temperature. Sample mixtures of the drug were tested for stability every 12 hours (60 hours maximum) at room temperature, every 24 hours (72 hours maximum), and at 8, 9, and 14 days under refrigerated conditions (5°C ± 3°C). Samples were assayed by using a high-performance liquid chromatographic method. The reconstituted caspofungin solutions maintained =90% of the original active concentration for the duration of this study under both storage conditions. Degradation product levels remained within historical limits throughout the course of this study. Furthermore, the initial concentration of the caspofungin solutions was found to have no effect on the study results.

Related Keywords: Maria Tsiouris, PhD, Marisa Ulmer, MS, James F. Yurcho, BS, Kevin L. Hooper, BS, Min Gui, PhD, reconstituted caspofungin, antifungal agent, fungal infection, stability, compatibility, elastomeric infusion devices, storage conditions


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