Tokhadzé Nicolas, Chennell Philip, Pereira Bruno, Mailhot-Jensen Bénédicte, Sautou Valérie
Université Clermont Auvergne, CHU Clermont Ferrand, Clermont Auvergne INP, CNRS, ICCF, F-63000 Clermont-Ferrand, France.
CHU Clermont-Ferrand, Unité de biostatistiques, DRCI, F-63000 Clermont-Ferrand, France.
Pharmaceutics. 2021 Oct 16;13(10):1709. doi: 10.3390/pharmaceutics13101709.
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.
硅胶和聚氨酯是用于制造可植入导管的生物相容性材料，但已知它们会因吸附导致药物损失，从而引发潜在的重要临床后果。尽管如此，它们对通过其输注的药物的影响很少被研究，或者只是单独进行研究，并非完整输液装置的一部分。这项工作的目的是通过实验研究这些装置自身以及在完整输液装置中可能导致的药物损失。选择对乙酰氨基酚、地西泮和胰岛素作为模型来评估药物吸附。对四种常用的硅胶和聚氨酯导管分别进行了研究，并将其作为由注射器、延长管以及硅胶或聚氨酯可植入导管组成的两种不同装置的一部分。测试了单独通过导管或通过完整装置以1 mL/h和10 mL/h的流速进行模拟输注的情况。通过液相色谱监测药物浓度，并通过衰减全反射红外光谱（ATR-IR）和Zeta表面电位测量对硅胶和聚氨酯材料进行表征。在完整装置中观察到的损失与装置中吸附性最强的装置单独引起的损失趋势相同。在完整装置中，未观察到对乙酰氨基酚的损失，但使用聚氨酯导管时，地西泮和胰岛素的最大损失分别为96.4 ± 0.9%和54.0 ± 5.6%。总体而言，导管被证明是导致一些极高药物损失的原因，而在装置中优化延长管并不能抵消这些损失。
