Leaching of plasticizers from polyvinylchloride perfusion lines by different lipid emulsions for premature infants under clinical conditions

Int J Pharm. 2017 Mar 30;520(1-2):119-125. doi: 10.1016/j.ijpharm.2017.01.046. Epub 2017 Jan 23.

Abstract

Plasticizers migrate from polyvinylchloride (PVC) infusion systems into lipid emulsions. The aim of this study was to investigate the leaching of different plasticizers from PVC perfusion lines by a selection of lipid emulsions under clinical conditions. Seven PVC perfusion lines with an equal length of 150cm and three internal diameters were perfused with three lipid emulsions: Intralipid® 20%, ClinOleic® 20% and SMOFlipid® 20%, mimicking clinical conditions. The concentrations of the plasticizers were measured directly in the emulsions by gas chromatography - mass spectrometry. Of the four plasticizers examined in this study, di (2-ethylhexyl) phthalate (DEHP) leached the most and was found, on average, at 46.5μg/ml in the emulsions - around one order of magnitude higher than the other plasticizers. This study demonstrates that the leaching of DEHP by lipid emulsions in conditions of total parenteral nutrition is many times higher than should be accepted and higher when compared to the other plasticizers. There was no significant difference in leaching of plasticizers in relation to the type of lipid emulsion. The influence of tube diameter on the leaching rate of plasticizers should be taken into account especially in particular exposed patients.

Keywords: DEHP; Leaching; Lipid emulsion; Perfusion line; Plasticizer; Polyvinylchloride; Premature infants; Smof; Total parenteral nutrition; di (2-ethylhexyl) phthalate.

MeSH terms

  • Fat Emulsions, Intravenous / chemistry*
  • Humans
  • Infant, Newborn
  • Infant, Premature*
  • Perfusion / instrumentation*
  • Plasticizers / analysis*
  • Plasticizers / chemistry*
  • Polyvinyl Chloride / chemistry*

Substances

  • Fat Emulsions, Intravenous
  • Plasticizers
  • Polyvinyl Chloride