The extraction of diethylhexylphthalate (DEHP) from polyvinyl chloride components of intravenous infusion containers and administration sets by paclitaxel injection

Abstract

Paclitaxel injection (Taxol TM) contains cremophor and ethanol in equal proportions, two agents known to leach diethylhexylphthalate (DEHP) from polyvinyl chloride (PVC) infusion bags and administration sets. The manufacturers of paclitaxel therefore recommend the use of glass, polypropylene or polyolefin containers for storage. This recommendation poses a number of practical problems since the availability of these other types of containers is severely limited and as such staff may be unfamiliar in their handling. The aim of this study was to investigate the extent of DEHP extraction by paclitaxel injection contained in PVC infusion bags and administered by either PVC or non-PVC sets in a bid to verify the manufacturers' recommendations to avoid using PVC containers. The results indicated that during a 3 h infusion period, increasing amounts of DEHP were leached into the paclitaxel vehicle from both the PVC infusion bags and the standard PVC sets. The amounts of DEHP extracted depended on the concentration of the paclitaxel vehicle, the length of contact between the injection vehicle and the container and the type of administration set used. DEHP concentration was at its lowest when a non-PVC set was used to administer the infusate. The addition of 300 and 600 mg paclitaxel to the infusate, administered by non-PVC sets, led to no significant increase in DEHP extraction. Comparative total amounts of DEHP extracted for each dose were 10.0 and 30.3 mg for the paclitaxel vehicle infusion through non-PVC sets and 13 and 30.5 mg respectively for the formulated drug plus vehicle. These amounts of DEHP are substantially less than those delivered during a blood transfusion. Furthermore, the possibility of chronic exposure to DEHP from paclitaxel administered under these conditions is negligible in patients receiving the drug on four to six occasions. The study concludes that there is only minimal risk of DEHP exposure from paclitaxel infusion contained in PVC bags and administered through non-PVC administration sets.