title: Reducing the migration of di-2-ethylhexyl phthalate from polyvinyl chloride medical devices.
abstract: We attempted to determine the processing conditions for decreasing the migration of phthalate esters, particularly di-2-ethylhexyl phthalate (DEHP), from polyvinyl chloride (PVC) products using a drug solvent after dilution based on the package insert. PVC sheets and PVC tubing were subjected to optical irradiation (ultraviolet (UV), visible light irradiation) and heat treatment to determine whether they are deteriorated by these treatments. UV irradiation to one side of the PVC sheet decreased the levels of DEHP migration from the sheets by almost 50%, although the amount of DEHP content in PVC sheet was observed no significant change. On the other hand, the levels of DEHP migrating from the inner surface of PVC tubing UV-irradiated from the outer surface were not decreased compared with the control. Therefore, the surface structure was examined by conducting Fourier transform infrared spectroscopy (FT-IR), electron spectroscopy for chemical analysis (ESCA) and static angle of contact measurement. In FT-IR analysis, we found that the UV-irradiated PVC sheets were exhibited broadened absorption bands with time. In ESCA analysis, the chlorine content was decreased and the oxygen content was increased with time in UV-irradiated PVC sheets. Moreover, the other treated PVC sheets shows no significant change compared with the non-UV-irradiated PVC sheet. Therefore, the surface structure of the UV-irradiated PVC sheet was changed. As a result, the migration of DEHP from PVC products can be decreased with simple treatment, such as UV-irradiation. This could be a useful method to develop novel PVC products.
authors.affiliation: Department of Analytical Chemistry, Faculty of Pharmaceutical Sciences, Hoshi University, 2-4-41 Ebara, Tokyo 142-8501, Japan.
authors.forename: Rie
authors.initials: R
authors.lastname: Ito
authors.forename: Fumie
authors.initials: F
authors.lastname: Seshimo
authors.forename: Yuji
authors.initials: Y
authors.lastname: Haishima
authors.forename: Chie
authors.initials: C
authors.lastname: Hasegawa
authors.forename: Kazuo
authors.initials: K
authors.lastname: Isama
authors.forename: Takeshi
authors.initials: T
authors.lastname: Yagami
authors.forename: Keisuke
authors.initials: K
authors.lastname: Nakahashi
authors.forename: Haruko
authors.initials: H
authors.lastname: Yamazaki
authors.forename: Koichi
authors.initials: K
authors.lastname: Inoue
authors.forename: Yoshihiro
authors.initials: Y
authors.lastname: Yoshimura
authors.forename: Koichi
authors.initials: K
authors.lastname: Saito
authors.forename: Toshie
authors.initials: T
authors.lastname: Tsuchiya
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Nakazawa
mesh_terms: D016572:Cyclosporine; D004051:Diethylhexyl Phthalate / Q000032:analysis / Q000737:chemistry*; D004869:Equipment Safety; D008401:Gas Chromatography-Mass Spectrometry; D010968:Plasticizers / Q000032:analysis / Q000737:chemistry*; D011143:Polyvinyl Chloride / Q000737:chemistry* / Q000528:radiation effects; D046590:Spectroscopy, Electron Energy-Loss; D017550:Spectroscopy, Fourier Transform Infrared; D013499:Surface Properties; D013718:Tensile Strength; D013997:Time Factors; D014466:Ultraviolet Rays
chemical_list: D010968:Plasticizers; D016572:Cyclosporine; D011143:Polyvinyl Chloride; D004051:Diethylhexyl Phthalate