Paclitaxel stability and compatibility in polyolefin containers

To determine the compatibility and stability of paclitaxel in polyolefin containers.

The following paclitaxel concentrations were determined by a stability-indicating HPLC method: 0.3 and 1.2 mg/mL diluted in dextrose 5% for injection, USP (D5W) or sodium chloride 0.9% for injection, USP (NS). The solutions were prepared in polyolefin containers and the stability and compatibility were monitored for 48 hours when stored at ambient temperature (20-23 degrees C) and normal fluorescent lighting. A mixture of the drug carrier consisting of approximately 10% polyoxyethylated castor oil (Cremophor EL) and 10% ethanol in D5W and NS, without paclitaxel, was studied to differentiate the effect of paclitaxel from the effect of the drug carrier on the container. Paclitaxel concentrations, pH changes, and visual clarity were used as stability and compatibility indicators.

Paclitaxel concentrations remained at 96-99 percent of the initial concentration for up to 48 hours when placed in the polyolefin containers. No changes in color or visual clarity were noted. Only minor changes in the pH of the admixtures were observed.

Paclitaxel diluted in D5W or NS at concentrations of 0.3 and 1.2 mg/mL is stable and compatible in flexible, polyolefin containers for up to 48 hours.