Do plasticized polyvinylchloride and polyurethane infusion sets promote infliximab adsorption?

Abstract Objectives Infliximab diluted solutions have been shown to be physicochemically stable for long periods, however the adsorption of infliximab during infusions has not been readily investigated. This study aimed to evaluate potential adsorption phenomena of infliximab during administration through Polyvinylchloride (PVC) and Polyurethane (PU) infusion sets. Methods Infliximab (INFLECTRA®) solutions at 0.4 mg/mL and 2 mg/mL were submitted to static (at T0, 24 and 96 h) and dynamic contact (flow rate of 2 mL/min during 2 h with analysis times at T0, 5 min, 30 min, 60 min and 120 min) with three different infusion sets. Two contained PVC plasticized with tris(2-ethylhexyl) trimellitate (TOTM) tubings and one set was in PU tubing. Infliximab was quantified at each analytical time by protein total quantification using UV-spectroscopy according to European Pharmacopeia Monography (2.5.33) and size exclusion chromatography (SEC) which allowed a specific quantification of the monomeric form and was able to highlight potential modification such as aggregation or oligomer formation. Results For all analysis times and conditions, infliximab concentrations remained unchanged with a maximum variation of 2.81 and 4.63% from the initial concentrations assessed by SEC and UV spectroscopy and the percentage of monomeric form remained unaltered. Conclusions Our study showed that there was no significant loss of infliximab. According to these results each of the three infusion sets could be used for the administration of infliximab solutions without causing any loss of active substance.