Universite Clermont Auvergne, CHU Clermont Ferrand, CNRS, Sigma Clermont, ICCF, 63000 Clermont-Ferrand, France.
Universite Clermont Auvergne, CNRS, SIGMA Clermont, ICCF, 63000 Clermont-Ferrand, France.
J R Soc Interface. 2019 Sep 27;16(158):20180721. doi: 10.1098/rsif.2018.0721. Epub 2019 Sep 25.
This work aims to evaluate the possible impact of interactions between bevacizumab solutions and an implantable port equipped with a silicone or a polyurethane catheter after infusion through a complete infusion set-up in simulated use conditions. Physico-chemical and structural stability of bevacizumab solution was assessed by visual examination, subvisible particles counting, dynamic light scattering, size exclusion chromatography and ion exchange chromatography. Mechanical properties of the catheters were evaluated by measuring Shore A hardness, strain at break, strain at stress and Young's modulus. The physico-chemical surface state of the catheters was assessed by FTIR-ATR spectroscopy, scanning electron microscopy (SEM) and by water contact angle measurement. The analysis of the bevacizumab solution did not highlight any signs of instability or loss of active substance. Mechanical properties of both materials remained unchanged after the infusion. During material analysis, a decrease in water contact angle observed after infusion and was more pronounced for polyurethane catheters than for silicone, possibly due to bevacizumab adsorption or possible leachable extraction from the materials. Surface modifications were also noted at SEM. This study did not highlight any modifications that could alter the quality of the bevacizumab infusion, nor of the infusion catheter in polyurethane or silicone, despite a modification of surface hydrophilicity. Even if after a single infusion, implantable ports remained safe to use, they aim to be used for several infusion of various drugs during their lifetime, and further studies are needed to assess the impact of repeated infusions.
本研究旨在评估贝伐珠单抗溶液与装有硅胶或聚氨酯导管的植入式输液港在模拟使用条件下通过完整的输液装置输注后相互作用的可能影响。通过目视检查、亚可见颗粒计数、动态光散射、尺寸排阻色谱和离子交换色谱评估贝伐珠单抗溶液的物理化学和结构稳定性。通过测量邵氏 A 硬度、断裂伸长率、断裂应变速率和杨氏模量评估导管的机械性能。通过傅里叶变换衰减全反射光谱(FTIR-ATR)、扫描电子显微镜(SEM)和水接触角测量评估导管的物理化学表面状态。贝伐珠单抗溶液的分析未显示出任何不稳定性或活性物质损失的迹象。两种材料的机械性能在输注后保持不变。在材料分析过程中,观察到输注后水接触角降低,且在聚氨酯导管中比在硅胶导管中更为明显,这可能是由于贝伐珠单抗吸附或材料中可能可浸出物的提取。在 SEM 中也观察到表面改性。这项研究没有发现任何可能改变贝伐珠单抗输注质量或聚氨酯或硅胶输注导管质量的变化,尽管表面亲水性有所改变。即使在单次输注后,植入式输液港仍可安全使用,但它们旨在在其使用寿命内用于输注多种不同的药物,因此需要进一步研究来评估重复输注的影响。