Paclitaxel compatibility with a TOTM-plasticized PVC administration set

The purpose of this project was to determine the compatibility of paclitaxel infusions and a SoloPak Primary Solution Set. The authors evaluated two potential problems with the administration set: (1) the extraction of tris(2-ethylhexyl)trimellitate (TOTM) plasticizer from the plastic matrix by the Cremophor EL® surfactant in the paclitaxel injection, and (2) paclitaxel loss to the plastic matrix. TOTM extraction was tested using the paclitaxel diluent at concentrations equivalent to 0.3 mg/mL and 1.2 mg/mL over 3-hour and 4-day infusions. The amount of paclitaxel delivered through the set was determined using paclitaxel 0.3 mg/mL infused over 24 hours at about 23 °C Both TOTM content and delivered paclitaxel amounts were determined using high-performance liquid chromatography. In addition, visual and turbidimetric evaluations of the test solutions in the original containers and the administration set effluent were performed. None of the admixtures delivered over 3 hours or the simulated 0.3 mg/mL admixture delivered over 4 days contained a detectable amount of TOTM. The simulated 1.2 mg/mL admixture delivered over 4 days yielded a barely detectable, but not quantifiable, trace of TOTM. Furthermore, the physical and chemical integrity of the paclitaxel 0.3 mg/mL admixture was retained after delivery through the set, and no loss of paclitaxel was found. The authors conclude that the tested SoloPak TOTM-plasticized PVC administration set is suitable for both long- and short-duration paclitaxel infusions.