Abstract
Silicone and polyurethane are biocompatible materials used for the manufacture of implantable catheters, but are known to induce drug loss by sorption, causing potentially important clinical consequences. Despite this, their impact on the drugs infused through them is rarely studied, or they are studied individually and not part of a complete infusion setup. The aim of this work was to experimentally investigate the drug loss that these devices can cause, on their own and within a complete infusion setup. Paracetamol, diazepam, and insulin were chosen as models to assess drug sorption. Four commonly used silicone and polyurethane catheters were studied independently and as part of two different setups composed of a syringe, an extension set, and silicone or polyurethane implantable catheter. Simulated infusion through the catheter alone or through the complete setup were tested, at flowrates of 1 mL/h and 10 mL/h. Drug concentrations were monitored by liquid chromatography, and the silicone and polyurethane materials were characterized by ATR-IR spectroscopy and Zeta surface potential measurements. The losses observed with the complete setups followed the same trend as the losses induced individually by the most sorptive device of the setup. With the complete setups, no loss of paracetamol was observed, but diazepam and insulin maximum losses were respectively of 96.4 ± 0.9% and 54.0 ± 5.6%, when using a polyurethane catheter. Overall, catheters were shown to be the cause of some extremely high drug losses that could not be countered by optimizing the extension set in the setup.
Highlights
The parenteral administration of drugs into the vascular system through the skin requires the use of an infusion line, which is composed of many different medical devices (MDs), from the syringe or medication bag to the catheter, including potentially infusion and extension sets, on-line filters, etc
The spectra obtained for the Blue FlexTip® and PowerPicc® catheters showed a high degree of similarity in favor of a very similar composition
This work used model drugs, such as paracetamol, diazepam, and insulin to investigate drug losses during infusions. It highlighted that silicone and PUR catheters can be at the origin of extremely high losses of diazepam and insulin, caused by sorption phenomena
Summary
The parenteral administration of drugs into the vascular system through the skin requires the use of an infusion line, which is composed of many different medical devices (MDs), from the syringe or medication bag to the catheter, including potentially infusion and extension sets, on-line filters, etc. [1]. Drug loss by sorption can result from two main mechanisms [3]: adsorption, which corresponds to the interactions of the compounds with the surface of the material, and absorption, which is the migration of the previously adsorbed compounds into the polymer matrix As these phenomena can be responsible for potentially critical drug underdosing, or even for a complete loss of activity in the worst case, it is important to Pharmaceutics 2021, 13, 1709. Catheters are of tantamount importance as they are implanted through the skin into the blood circulation and administer the drugs into the patients’ body They are almost exclusively made of polyurethane (PUR) or silicone, and these materials, despite their great biocompatibility, have been shown to be at high risk of causing drug loss by sorption [13,14,15,16,17,18], but these studies are few, not recent, and do not take into account the whole infusion setup
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