Maiguy-Foinard Aurélie, Blanchemain Nicolas, Barthélémy Christine, Décaudin Bertrand, Odou Pascal
Univ. Lille, EA 7365 - GRITA - Groupe de Recherche sur les formes Injectables et les Technologies Associées, F-59000 Lille, France.
CHU Lille, Institut de Pharmacie, F-59000 Lille, France.
PLoS One. 2016 May 6;11(5):e0154917. doi: 10.1371/journal.pone.0154917. eCollection 2016.
Plastic materials such as polyurethane (PUR), polyethylene (PE), polypropylene (PP) and polyvinyl chloride (PVC) are widely used in double-lumen extension tubing. The purposes of our study were to 1) compare in vitro drug delivery through the double extension tubes available on the market 2) assess the plastic properties of PUR in infusion devices and their impact on drug delivery.
The study compared eight double-lumen extension tubes in PUR, co-extruded (PE/PVC) plastic and plasticised PVC from different manufacturers. Isosorbide dinitrate and diazepam were used as model compounds to evaluate their sorption on the internal surface of the infusion device. Control experiments were performed using norepinephrine known not to absorb to plastics. Drug concentrations delivered at the egress of extension tubes were determined over time by an analytical spectrophotometric UV-Vis method. The main characteristics of plastics were also determined.
Significant differences in the sorption phenomenon were observed among the eight double-lumen extension tubes and between pairs of extension tubes. Mean concentrations of isosorbide dinitrate delivered at the egress of double-lumen extension tubes after a 150-minute infusion (mean values ± standard deviation in percentage of the initial concentrations in the prepared syringes) ranged between 80.53 ± 1.66 (one of the PUR tubes) and 92.84 ± 2.73 (PE/PVC tube). The same parameters measured during diazepam infusion ranged between 48.58 ± 2.88 (one of the PUR tubes) and 85.06 ± 3.94 (PE/PVC tube). The double-lumen extension tubes in PUR were either thermosetting (resin) or thermoplastic according to reference.
Clinicians must be aware of potential drug interactions with extension tube materials and so must consider their nature as well as the sterilisation method used before selecting an infusion device.
聚氨酯(PUR)、聚乙烯(PE)、聚丙烯(PP)和聚氯乙烯(PVC)等塑料材料广泛应用于双腔延长管。本研究的目的是:1)比较市场上现有双腔延长管的体外药物输送情况;2)评估输液装置中PUR的塑料特性及其对药物输送的影响。
本研究比较了不同制造商生产的8种双腔延长管,材质分别为PUR、共挤出(PE/PVC)塑料和增塑PVC。采用硝酸异山梨酯和地西泮作为模型化合物,评估它们在输液装置内表面的吸附情况。使用已知不会吸附到塑料上的去甲肾上腺素进行对照实验。通过紫外可见分光光度分析方法,随时间测定延长管出口处的药物浓度。同时还测定了塑料的主要特性。
在8种双腔延长管之间以及成对的延长管之间,观察到吸附现象存在显著差异。输注150分钟后,双腔延长管出口处硝酸异山梨酯的平均浓度(以制备注射器中初始浓度的百分比表示,平均值±标准差)在80.53±1.66(一种PUR管)至92.84±2.73(PE/PVC管)之间。地西泮输注期间测量的相同参数在48.58±2.88(一种PUR管)至85.06±3.94(PE/PVC管)之间。根据参考资料,PUR材质的双腔延长管要么是热固性(树脂)的,要么是热塑性的。
临床医生必须意识到药物与延长管材料之间潜在的相互作用,因此在选择输液装置之前,必须考虑其材质以及所使用的灭菌方法。