期刊
EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES
卷 27, 期 2-3, 页码 133-142出版社
ELSEVIER SCIENCE BV
DOI: 10.1016/j.ejps.2005.09.001
关键词
plastic containers; leachables; partitioning
Material/water equilibrium interaction constants (E-b) were determined for 12 organic model solutes and a plastic material used in pharmaceutical product containers (non-PVC polyolefin). An excellent correlation was obtained between the measured interaction constants and the organic solute's octanol/water partition coefficient. The effect of solvent polarity on Eb was assessed by examining the interaction between the plastic and selected model solutes in binary ethanol/water mixtures. In general, logE(b) could be linearily related to the polarity of the ethanol/water mixture. This information, coupled with the interaction model, was used to estimate the levels to which container leachables could accumulate in contacted solutions. Such estimates were made for six known leachables of the polyolefin material and compared to the leachable's measured accumulation levels in binary ethanol/water systems. In general, the accumulation level of the leachables increased with increasing solution polarity. For most of the leachables, the measured accumulation level was less than the calculated levels, suggesting that equilibrium was not achieved in the leaching portion of this study This lack of equilibrium is attributable to the layered structure of the material studied, as such layering retards the migration of the leachables that are derived from the material's non-solution contact layers. (C) 2005 Elsevier B.V. All rights reserved.
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