Journal
INTERNATIONAL JOURNAL OF PHARMACEUTICS
Volume 352, Issue 1-2, Pages 139-145Publisher
ELSEVIER
DOI: 10.1016/j.ijpharm.2007.10.020
Keywords
di(2-ethylhexyl)phthalate; mono(2-ethylhexyl)phthalate; polyvinyl-chloride; enteral nutrition; medical product; neonate
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The leaching of di(2-ethylhexyl)phthalate (DEHP) and mono(2-ethylhexyl)phthalate (MEHP) from medical products made of polyvinyl-chloride (PVC) to enteral nutrition (EN) for neonatal patients was determined in a simulated study. The study simulated a typical case of EN administration to a neonatal patient (body weight, 3 kg) in a neonatal care unit (temperature, 25 degrees C); the medical products used were an irrigator and catheter containing DEHP (9.1-31.8%, w/w) as a plasticizer. The worst-case daily exposures of the neonatal patient to DEHP and MEHP by the administration of EN were estimated to be 148 and 3.72 mu g/(kg day), respectively, as assessed from the levels of these compounds leaching from the medical products to the EN. The use of DEHP-free medical products reduced the exposure of DEHP and MEHP to the minimum levels contained in the EN at preparation. A transition to DEHP-free medical products for neonatal patients would be effective in reducing the exposure of neonatal patients to DEHP via EN administration. (C) 2007 Elsevier B.V. All rights reserved.
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