Hybrid sol gel coating: A solution to prevent interactions between plasticized poly(vinyl chloride) and injectable drugs?

Abstract

During the infusion of drugs with medical devices in plasticized poly(vinyl chloride) (PVC) release of plasticizers in the injectable solution and/or sorption of drugs on PVC may occur. Thus, patient safety and/or effectiveness of his therapy may be altered. In this study, we assessed the efficiency of a sol gel hybrid coating in preventing plasticizers' release (di-(2-ethylhexyl) phthalate (DEHP)) from PVC matrix and drug sorption into PVC. Remaining concentrations of drugs and plasticizer's concentration released after migration tests were assessed by liquid chromatography. Migration processes were followed by Fourier Transform Infrared -Attenuated Total Reflectance (FTIR-ATR) spectroscopy and PVC surface changes were characterized by scanning electron microscopy (SEM). An evaluation of the mechanical properties of both uncoated and coated polymer was done. The hybrid coating protects PVC from plasticizers leaching. Sorption of drugs tested is also limited. However, the protection against plasticized PVC interactions isn't optimal, probably due to a degradation of the layer, as shown on SEM microphotographs. Furthermore improvements might provide an efficient barrier to advert risks impaired to PVC interactions, to provide patient care safety. V C 2013 Wiley Periodicals, Inc. J. Appl. Polym. Sci. 2014, 131, 40145.

Migration of plasticizers from PVC medical devices: Development of an infusion model.

“…These results are supported by Chellini et al, who demonstrated DEHP release from endoctracheal tubings in the early hours of intubation [24]. These data was confirmed by Bernard et al as part of a study to evaluate the efficiency of a protective PVC barrier against this release [20]. The method of administration of injectable drugs varies from one product to another and depends on the indication, the volume to be delivered, the product's nature, and the profile of the patient.…”

“…The analysis of the drugs and products administered by injection enabled the distinction to be The data in the literature shows that the fatty nature of the solvents has a considerable influence on the extraction of the plasticizers from the PVC [16] [18], with a strength that is comparable to that of ethanol [19] [20], thus justifying its use as a simulant. In order to establish our models, it was therefore necessary to check the differences in lipid content of the identified drugs.…”

Effect of liquid plasticizers on crystallization of PCL in soft PVC/PCL/plasticizer blends

“…Nevertheless, these alternative plasticizers are still small molecular compounds and migration of plasticizers from soft PVC is unavoidable during long‐time service, which would result in decreasing of durability. Several strategies have been developed to reduce migration of small molecular plasticizers from flexible PVC, including surface crosslinking, surface grafting, surface coating, coextrusion, mixing with nano‐particles, internal plasticization, blending, and so forth. Blending with macromolecular plasticizers is one of the few solutions which combines practicability with effectiveness, due to its ease of manufacturing and nonmigratory nature of polymers.…”