Leaching of diethylhexyl phthalate from multilayer tubing into etoposide infusion solutions

被引:32
作者
Bagel-Boithias, S
Sautou-Miranda, V
Bourdeaux, D
Tramier, V
Boyer, A
Chopineau, J
机构
[1] Gabriel Montpied Hosp, Dept Pharm, Clermont Ferrand, France
[2] UFR Pharm, Lab Clin Pharm & Biotechn, F-63001 Clermont Ferrand, France
关键词
antineoplastic agents; concentration; contamination; diethylhexyl phthalate; drug administration rate; ethyl vinylacetate; etoposide; flow; injections; leaching; plasticizers; polyethylene; polymers; polyvinyl chloride; stability; storage; tubing;
D O I
10.1093/ajhp/62.2.182
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
Purpose. The extent of leaching of diethylhexyl phthalate (DEHP) from various polyvinyl chloride (PVC), polyethylene (PE), coextruded (PVC and PE), and triple-layered (PVC, ethyl vinyl acetate, and PE) i.v. extension tubing into etoposide infusion solutions was studied. Methods. Different lengths of tubing (25, 50, and 80 cm) were tested in two types of experiments: (1) static, in which the etoposide solution was left in contact inside the tubing for various times and then removed, and chromatography was used to quantify the DEHP content of the effluate, and (2) dynamic, in which infusion was simulated using syringe reservoirs, and three flow rates were tested to assess the effect of flow rate on the quantities of DEHP leached. Results. The static study showed that large quantities of DEHP were leached from all tubing types except the PE tubing. The dynamic study confirmed. that leaching occurred, although the values were below the threshold limit of 5 mug/mL. The values varied depending on flow rate, tubing length, and etoposide concentration. The coextruded and triple-layered i.v. tubing did not provide the inertness and safety they are intended to have, as DEHP not only leached out but did so in quantities almost equivalent to those found with tubing made of PVC only. Conclusion. DEHP leached rapidly from PVC, coextruded, and triple-layered i.v. tubing into etoposide infusion solution. The quantity of DEHP found in the infusion solution was influenced by the length of the tubing and concentration of etoposide.
引用
收藏
页码:182 / 188
页数:7
相关论文
共 20 条
[1]   Modulation of rat Leydig cell steroidogenic function by di(2-ethylhexyl)phthalate [J].
Akingbemi, BT ;
Youker, RT ;
Sottas, CM ;
Ge, RS ;
Katz, E ;
Klinefelter, GR ;
Zirkin, BR ;
Hardy, MP .
BIOLOGY OF REPRODUCTION, 2001, 65 (04) :1252-1259
[2]  
Centro de Estudios de Opinion, 2001, SAF ASS DI 2 ETH PHY, P1
[3]  
*CTR EV RISKS HUM, 2000, NTPCERHRDEHP00
[4]   Leaching of diethylhexyl phthalate from polyvinyl chloride bags into intravenous etoposide solution [J].
Demoré, B ;
Vigneron, J ;
Perrin, A ;
Hoffman, MA ;
Hoffman, M .
JOURNAL OF CLINICAL PHARMACY AND THERAPEUTICS, 2002, 27 (02) :139-142
[5]  
*ENV CAN HLTH CAN, CAN ENV PROT ACT PR
[6]  
Gras C, 2002, EJHP, V8, P33
[7]   Investigation of the release behavior of diethylhexyl phthalate from the polyvinyl-chloride tubing for intravenous administration [J].
Hanawa, T ;
Muramatsu, E ;
Asakawa, K ;
Suzuki, M ;
Tanaka, M ;
Kawano, K ;
Seki, T ;
Juni, K ;
Nakajima, S .
INTERNATIONAL JOURNAL OF PHARMACEUTICS, 2000, 210 (1-2) :109-115
[8]  
*HLTH CAN, DEHP MED DEV EXP TOX
[9]  
Jobet-Hermelin I., 1996, Journal de Pharmacie Clinique, V15, P132
[10]   Evaluation of childhood exposure to di(2-ethylhexyl) phthalate from perfusion kits during long-term parenteral nutrition [J].
Kambia, K ;
Dine, T ;
Gressier, B ;
Bah, S ;
Germe, AF ;
Luyckx, M ;
Brunet, C ;
Michaud, L ;
Gottrand, F .
INTERNATIONAL JOURNAL OF PHARMACEUTICS, 2003, 262 (1-2) :83-91