Release behavior of diethylhexyl phthalate from the polyvinyl-chloride tubing used for intravenous administration and the plasticized PVC membrane

The release behavior of diethylhexyl phthalate (DEHP) from polyvinyl-chloride (PVC) tubing, which composes materials in an intravenous administration set, was investigated using polysorbate 80 (Tween 80) aqueous solutions. When Tween 80 solution was circulated in PVC tubing, the amount of DEHP released increased with increasing circulation velocity and temperature. In order to clarify the effect of temperature on the release behavior of DEHP, PVC films containing varying amounts of DEHP were mounted on a cylindrical shaft and rotated at 5 and 40 degrees C. The cumulative amount of DEHP released increased with an increase in temperature, the diffusion coefficients [D x 10(-10) cm(2) min(-1)] at 5 and 40 degrees C were 9.1 and 156.0, respectively. The glass transition temperature (T-g) of PVC films decreased with an increase in DEHP in the PVC film, as measured by differential scanning calorimeter (DSC) and release of DEHP occurred at temperatures above Tg. These results indicate that the release of DEHP from PVC tubing is closely associated with the state of the PVC and is related to diffusion of DEHP throughout the PVC. (c) 2005 Elsevier B.V. All rights reserved.