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Abstract:  The purpose of this project was to evaluate the compatibility of paclitaxel infusions with the IV Express™ filter unit, a 0.22- µm intravenous solution filter (Millipore Corporation, Bedford, MA). The potential for extraction of diethylhexyl phthalate plasticizer from the filter unit by the Cremophor® EL surfactant present in the paclitaxel injection and the potential for loss of paclitaxel to filter unit components due to sorption were evaluated.

Plasticizer extraction was tested using the paclitaxel diluent at a concentration equivalent to 1.2 mg/mL over a three-hour simulated infusion. Paclitaxel delivery was evaluated in admixtures containing paclitaxel 0.3 mg/mL. All samples were prepared in triplicate in polyolefin bags of 5% dextrose injection and delivered through IV Express filter units attached to nonpolyvinyl chloride administration sets designed for the administration of paclitaxel infusions. The samples were collected in glass collection flasks. Both plasticizer and paclitaxel content were determined using specific high-performance liquid chromatographic methods.

None of the admixtures delivered over three hours through the IV Express filter unit exhibited any detectable plasticizer. Further, no loss of paclitaxel due to sorption to any filter component occurred; the full amount of paclitaxel was delivered in the simulated infusions.

The IV Express filter unit tested in this study is suitable for the administration of paclitaxel infusions over three hours.

Related Categories: CANCER AND AIDS, PEER-REVIEWED, STABILITIES, COMPATIBILITIES

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