Abstract
Medical tubings in plasticized polyvinylchloride (PVC) are widely used for the infusion of medications but are known in some cases to cause content-container interactions (drug sorption and plasticizer release). The aim of this study was to assess interactions between drugs and five alternative materials to a reference plasticized PVC intravenous (IV) infusion tubing: three were PVC coextruded with polyethylene (PE), polyurethane (PU) or a thermoplastic elastomer (Styrene-EthyleneButadiene-Styrene (SEBS)) and two were SEBS or thermoplastic olefin (TPO) monolayer tubings. Diazepam and insulin were chosen as respective reference of absorption and adsorption while paracetamol acted as a negative control. The concentration of each drug was quantified with liquid chromatography to evaluate a potential loss after a static contact condition and simulated infusion at 1 mL/h and 10 mL/h dynamic condition by an electric syringe pump. A characterization of each material’s surface was performed by Fourier transform infrared spectroscopy in attenuated total reflection mode (ATR-FTIR) and by measurement of surface zeta potential. Plasticizer release was quantified by gas chromatography coupled with mass spectrometry (GC-MS). For all tubings except PVC/PU, no loss of paracetamol was observed in any condition. Diazepam sorption appeared to be less important with PVC/PE, PVC/SEBS, SEBS and TPO tubings than with PVC, but was more important when using PVC/PU tubings. PVC tubings induced the least loss of insulin amongst all the studied materials. Surface analysis by ATR-FTIR highlighted the presence of a plasticizer (that could be attributed to Tris (2-Ethylhexyl) Trimellitate (TOTM)) in the coextruded SEBS layer of PVC/SEBS, which could have influenced drug sorption, probably as a consequence of a migration from the PVC layer. Coextruded PVC/SEBS and PVC/PE presented the lowest zeta potential of all studied materials with respective values of −39 mV and −36 mV and were related to the highest sorption of insulin while PVC/PU with the highest zeta potential (about −9 mV) presented the highest absorption of diazepam. Coextruded layered materials appeared to have a lower plasticizer release than PVC alone. As a conclusion, PVC/PE and thermoplastic elastomers alone or coextruded with PVC could be interesting alternatives to PVC tubings with regards to sorption phenomena and plasticizer release.
Highlights
Medical tubings in plasticized polyvinylchloride (PVC) are widely used for the infusion of medications but are known in some cases to cause content-container interactions
The limit of quantification of insulin was fixed at 0.03 UI/mL, limit at which the mean coefficients of repeatability, intermediate precision and relative trueness bias were of 4.08%, 8.31% and 12.27%, respectively
The overall result of effect size calculation based on the comparison of sorption rates at T8 between PVC and alternative tubings highlighted that the PVC/PU IV tubings were more prone to drug sorption than PVC with all tested molecules while PE and thermoplastic elastomers (PVC/SEBS, SEBS and thermoplastic olefin (TPO)) had a better behavior than PVC when in contact with diazepam
Summary
Medical tubings in plasticized polyvinylchloride (PVC) are widely used for the infusion of medications but are known in some cases to cause content-container interactions (drug sorption and plasticizer release). Our research team has shown that the addition of a coextruded inner layer of polyethylene (PE) in PVC infusion tubings appears to reduce plasticizer release[19], but the effect of other coextruded materials like polyurethane on plasticizer release has not yet been studied. In addition to their potential toxic effects, plasticizers have been shown to have an influence on drug sorption[20,21]. Identifying and evaluating material related factors appears as a challenging way to provide information to better understand drug sorption, and could help identify at-risk situations and select the best material for IV-tubings, and improve the control of the administered dose to the patient
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