Reducing the migration of di-2-ethylhexyl phthalate from polyvinyl chloride medical devices.
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.
Ito
Rie
R
Department of Analytical Chemistry, Faculty of Pharmaceutical Sciences, Hoshi University, 2-4-41 Ebara, Tokyo 142-8501, Japan.
Seshimo
Fumie
F
Haishima
Yuji
Y
Hasegawa
Chie
C
Isama
Kazuo
K
Yagami
Takeshi
T
Nakahashi
Keisuke
K
Yamazaki
Haruko
H
Inoue
Koichi
K
Yoshimura
Yoshihiro
Y
Saito
Koichi
K
Tsuchiya
Toshie
T
Nakazawa
Hiroyuki
H
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
D010968:Plasticizers; D016572:Cyclosporine; D011143:Polyvinyl Chloride; D004051:Diethylhexyl Phthalate