Effect of electron beam radio sterilization on cyclic olefin copolymers used as pharmaceutical storage materials

The aim of this work was to study the effect of radio-sterilization on cyclo olefin copolymers (COC), that can be used as pharmaceutical storage materials, both on the surface and in the volume of the material, and to investigate the impact of the presence of a lubricant. A cyclo olefin copolymer (TOPAS (R) 8007) was treated with an electron beam radio-sterilization at different doses ranging from 25 to 150 kGy. Polymer structure and bulk properties were evaluated by Fourier Transform Infrared Spectroscopy (FTIR), Differential Scanning Calorimetry (DSC) and Size Exclusion Chromatography (SEC). A good correlation between those analytical techniques was observed: oxidation products were formed and crosslinking of chains occured. Although these modifications were important, the effect on the thermal properties was weak. The analysis by Reversed Phase High Performance Liquid Chromatography (RP-HPLC) of extraction's solutions of COC after irradiation showed both a remarkable decrease of the extractable amount of polyphenolic antioxidant (Irganox 1010 (R)) initially present in the matrix, and a generation of an important number of degradation products that represent potential migrants for pharmaceutical formulations. Surface modifications were evidenced by both (FTIR/ATR) and contact angle measurements of COC films. An increase in surface polarity of COC after radio-sterilization was observed. (C) 2012 Elsevier Ltd. All rights reserved.