Leaching of diethylhexyl phthalate from polyvinyl chloride bags into intravenous cyclosporine solution.
The release of diethylhexyl phthalate (DEHP) from flexible polyvinyl chloride containers into intravenous cyclosporine solutions was studied. Intravenous cyclosporine solution or solutions containing the vehicle Cremophor EL and alcohol in dextrose were prepared in an all-glass system and stored in polyvinyl chloride (PVC) bags. Four samples were obtained at different time intervals, and DEHP content was analyzed by gas chromatography. The amount of DEHP that was leached into solutions stored in the PVC bags increased as storage time increased. By 48 hours, nearly 33 mg of DEHP had leached into the solution. Intravenous cyclosporine solutions should be prepared in glass containers to minimize patient exposure to DEHP. If plastic bags are used for preparing cyclosporine injections, the injections must be used immediately after preparation.
D003524:Cyclosporins / Q000008:administration & dosage* / Q000032:analysis; D004051:Diethylhexyl Phthalate / Q000032:analysis*; D004340:Drug Contamination; D004349:Drug Packaging; D005990:Glycerol / Q000031:analogs & derivatives / Q000032:analysis; D007262:Infusions, Intravenous / Q000295:instrumentation; D010795:Phthalic Acids / Q000032:analysis*; D011143:Polyvinyl Chloride / Q000032:analysis*; D011145:Polyvinyls / Q000032:analysis*
D003524:Cyclosporins; D010795:Phthalic Acids; D011145:Polyvinyls; C000515:cremophor EL; D011143:Polyvinyl Chloride; D004051:Diethylhexyl Phthalate; D005990:Glycerol