[The amount of the loss of cyclosporine A dose correlated with the amount of leaching di (2-ethylhexyl) phthalate from polyvinyl chloride infusion tube].
An interaction between cyclosporine A (CyA) injection and infusion tubes were examined. We used polyvinyl chloride (PVC) and polybutadiene (PB) tubes. CyA injection (Sandimmun) was diluted (0.495 mg CyA/ml) with saline and dripped through infusion tubes. The amounts of unsolved substances, loss of CyA dose and leached di (2-ethylhexyl) phthalate (DEHP) during the drip study were compared. CyA was not lost into the PB tube and no DEHP was leached. Therefore, using PVC tube, 11.9 mg of CyA were lost with in 24 h after the beginning of the administration, and the concentration of leached DEHP amounted to 93.6 micrograms/ml at 12 h. We also investigated the effects of the component of the einfusion solution on the loss of CyA into PVC tube using saline, electrolyte maintenance solution, 5% glucose and 10% maltose. Sugar-containing solutions were found to have less effects than other solutions on the loss of CyA dose and DEHP leaching. The leaching of DEHP may be a major factor for the generation of unsolved substances and the loss of CyA dose. In the clinical use of CyA injection, PB tube is the best selection and the sugar-containing solution is a second selection when PB infusion tubes are hard to obtain.
Yano
R
R
Department of Hospital Pharmacy, Fukui Medical University, 23 Shimoaizuki, Matsuoka-cho, Yoshida-gun, Fukui 910-1193, Japan.
Nakamura
T
T
Aono
H
H
Wakiya
Y
Y
Masada
M
M
D000327:Adsorption; D002070:Butadienes; D016572:Cyclosporine / Q000032:analysis / Q000737:chemistry; D004051:Diethylhexyl Phthalate / Q000032:analysis; D004340:Drug Contamination; D004355:Drug Stability; D020724:Elastomers; D007262:Infusions, Intravenous / Q000295:instrumentation*; D011108:Polymers; D011143:Polyvinyl Chloride; D013594:Syringes
D002070:Butadienes; D020724:Elastomers; D011108:Polymers; D016572:Cyclosporine; D011143:Polyvinyl Chloride; C028834:polybutadiene; D004051:Diethylhexyl Phthalate