• K Kambia, T Dine, B Gressier, S Bah, A-F Germe, M Luyckx, C Brunet, L Michaud, and F Gottrand.
• Laboratoire de Pharmacologie, Pharmacocinétique et Pharmacie Clinique, Faculté des Sciences Pharmaceutiques et Biologiques, BP 83, 59006 Lille, France.
• Int J Pharm. 2003 Aug 27;262(1-2):83-91.

AbstractLeachability of the plasticizer di(2-ethylhexyl) phthalate (DEHP) from administration sets into intravenous parenteral emulsions containing fat was investigated. DEHP is added to polyvinyl chloride (PVC) to impart flexibility. However, DEHP is a lipid-soluble suspected carcinogen that is hepatotoxic and teratogenic in rodents, and has been shown to leach from PVC products containing lipophilic mixtures. Consequently, total parenteral nutrition (TPN) mixtures containing fat emulsions should be stored in ethylvinyl acetate (EVA) bags rather than PVC packs. However, while TPN bags are made of EVA, they contain PVC-DEHP residues and the lines used between TPN bags and venous catheters are made of PVC-DEHP. The present study quantified the amount of DEHP leached from bags and tubing that could potentially contaminate patients during home TPN. Four types of emulsions containing fat were studied. Levels of DEHP in the bag and at the outlet tubing were measured by high-performance liquid chromatography (HPLC). This was measured during simulated TPN at different times after starting perfusion, 1 day after reconstitution of solutions in the bags, and 1 week later after storage at 4 degrees C. Detectable and stable amounts of DEHP were found to leach from bags (0.2 +/- 0.008 mg to 0.7 +/- 0.02 mg) and DEHP content increased in the outlet tubing (0.8 +/- 0.09 mg to 2 +/- 0.07 mg) during simulated infusions. The same phenomenon was observed after 1 week of storage at 4 degrees C. DEHP extraction by TPN depends on the lipid content of each TPN preparation and the flow rate. These results suggest that children treated with prolonged TPN are regularly exposed to significant amounts of DEHP.

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