Compatibility of paclitaxel injection vehicle with intravenous administration and extension sets.

Abstract

The compatibility of paclitaxel injection vehicle with a variety of i.v. administration and extension sets was studied in terms of the amount of diethylhexyl phthalate (DEHP) leached from the sets. Test solutions of paclitaxel injection vehicle corresponding to paclitaxel injection 0.3 and 1.2 mg/mL were prepared in polyolefin bags of 5% dextrose injection. The solutions were delivered in triplicate over 24 hours through 26 models of administration sets and 24 models of extension sets and collected in glass containers. Portions were removed after delivery and analyzed in duplicate for DEHP concentration by high-performance liquid chromatography. All the extension sets were compatible with paclitaxel injection vehicle. Most of the administration sets were also compatible. However, two administration sets were incompatible with paclitaxel vehicle corresponding to either drug concentration, and five sets were incompatible with the vehicle simulating the high (1.2-mg/mL) concentration. Some of the incompatible sets were labeled as not containing polyvinyl chloride (PVC). Solutions of paclitaxel vehicle leached DEHP from administration sets containing PVC and from some sets labeled as not containing PVC.