Effect of phospholipid coating on the migration of plasticizers from PVC tubes

Abstract

Plasticizers in polyvinyl chloride (PVC) are not covalently bound to the polymer and can thus migrate into the contact medium. The presented study investigated the potential effects of phospholipid-lining as anti-coagulation coating (ACC) on the migration rate of plasticizers from PVC tubing into blood.For the in-vitro study, five different groups of tubing sets in six replicates were perfused with sheep blood (Group A: PVC plasticized with di-(2-ethylhexyl) phthalate (DEHP) without ACC, Group B: DEHP-plasticized PVC with ACC, Group C: PVC plasticized with tri-(2-ethylhexyl) trimellitate (TOTM) without ACC, Group D: TOTM-plasticized PVC with ACC, Group E (control group): polyolefin material with ACC but without plasticizers). Both the levels of the unchanged plasticizers in blood and the concentration levels of their primary degradation products were assessed. For DEHP, the primary metabolite MEHP (mono-(2-ethylhexyl) phthalate) was determined. The isomers of MEHTM (mono-(2-ethylhexyl) trimellitate) and DEHTM (di-(2-ethylhexyl) trimellitate), respectively, were investigated as primary metabolites of TOTM.The calculated DEHP equivalents (sum of determined levels of DEHP and MEHP) after 24 h of perfusion displayed a tendency towards lower levels in the tubing sets without ACC (Group A (201 ± 56.4 μmol/L)) compared to the tubing sets with ACC (Group B (253 ± 369 μmol/L)). Significantly different DEHP equivalents between Group A and Group B were found after a perfusion time of 6 h and 10 h, respectively. A similar effect was observed for the TOTM-containing tubing sets. However, the absolute plasticizer migration rate of TOTM (TOTM equivalents) after 24 h of perfusion was found to be significantly lower compared to that of DEHP (with a factor of over 200).The results indicate that phospholipid coating (ACC) rather enhances the migration of plasticizers and of their primary degradation products from PVC tubing into streaming blood. The enhancement effect was found to be slightly greater for TOTM, but as TOTM migrates in significantly lower levels than DEHP in all experimental settings, TOTM is confirmed to be a recommendable alternative plasticizer to DEHP in medical devices.