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Comparative Study
. 2003 Nov 28;267(1-2):141-9.
doi: 10.1016/j.ijpharm.2003.08.009.

Investigation of the Release Behavior of Diethylhexyl Phthalate From Polyvinyl Chloride Tubing for Intravenous Administration Based on HCO60

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Comparative Study

Investigation of the Release Behavior of Diethylhexyl Phthalate From Polyvinyl Chloride Tubing for Intravenous Administration Based on HCO60

Takehisa Hanawa et al. Int J Pharm. .

Abstract

The release behavior of diethylhexyl phthalate (DEHP) from polyvinyl chloride (PVC) tubing, which composes materials in an intravenous administration set (IAS), was investigated using polyoxyethylated hydrogenated castor oil (HCO60) in physiological saline (PS), distilled water for injection (DWI), and ribose, fructose, and glucose (TZ) solutions. The amount of DEHP released increased with increasing HCO60 concentration, and the cumulative amount of DEHP released after 4h increased in the following order: 50% TZ<DWI=PS. At HCO60 levels above and below critical micelle concentration, no significant increase in the amount of DEHP released was observed; the release of DEHP appeared due to molecular interactions between DEHP and HCO60 molecules rather than the solubilization of DEHP into micelles. The release behavior of DEHP was affected by the addition of sugars. The amount of DEHP released decreased with an increase in the mean numbers of equatorial OH groups n(e-OH) per molecule in the following order: glucose [n(e-OH);4.6]<fructose(3.0)<ribose(2.1). Molecular mobility of HCO60 was assumed to be restricted by interaction with the sugar molecule and/or the extent of microscopic viscosity. Interaction of HCO60 with the sugar, the difference in the mode, and/or the extent of molecular interaction between sugar and HCO60 appeared to induce the difference in release behavior, while the increase in the number of water molecules needed to hydrate sugar molecules seemed to decrease the amount of free water, thus allowing microscopic viscosity to increase and to restrict the mobility of HCO60. These results suggest that the release of DEHP from PVC tubing is closely associated with the interaction of DEHP with HCO60, and related to the molecular mobility of HCO60 in solution.

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