Stability and compatibility of reconstituted caspofungin in select elastomeric infusion devices

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 degrees Celsius +/- 3 degrees Celsius 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 degrees Celsius +/- 3 degrees Celsius). Samples were assayed by using a high-performance liquid chromatographic method. The reconstituted caspofungin solutions maintained (greater than or equal to 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.