Compatibility of Paclitaxel in 5% Glucose and 0.9% Sodium Chloride Injections with EVA Minibags

Abstract

Aim: To evaluate the compatibility of a paclitaxel formulation ( Anzatax, Faulding) at concentrations of 0.3 and 1.2 mg/mL in 5% glucose injection and 0.9% sodium chloride injection with Baxter ethylene vinyl acetate (EVA) solution containers. We evaluated the potential for leachable materials to be extracted from the EVA bag by the paclitaxel formulation and the potential for paclitaxel loss due to sorption to the plastic. Method: The paclitaxel admixtures at both concentrations were prepared and stored at 25 and 32 degrees Celcius, protected from light, for 72 hours. All admixtures were prepared in triplicate in the EVA minibags; samples were drawn from the containers initially upon preparation and after 24 and 72 hours of storage. The paclitaxel concentrations of the samples and the extractable content from the container were determined using separate high performance liquid chromatographic methods. Leached material was analysed by mass spectrometer. Results: Paclitaxel was chemically stable throughout the 72-hour study period exhibiting no loss due to decomposition or sorption in any of the admixtures. However, an unknown material was leached from the EVA containers, appearing in both the 24- and 72-hour samples. The unknown material chromatographed very similarly to an unknown that was extracted by contact of the plastic with pure acetonitrile. The unknown primarily consisted of three entities having masses of 888.69, 932.68, and 976. 73 daltons and may be leached polymeric material varying in the number of associated acetate groups. Conclusion: Paclitaxel is chemically stable at 0.3 and 1.2 mg/mL in 5% glucose injection and in 0.9% sodium chloride injection in EVA containers for up to 72 hours at 25 and 32 degrees celcius. However, some material of unknown identity was leached into the drug admixture from the container within 24 hours. (author abstract)