کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
2482526 1556300 2006 10 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
The effect of solvent polarity on the accumulation of leachables from pharmaceutical product containers
موضوعات مرتبط
علوم پزشکی و سلامت داروسازی، سم شناسی و علوم دارویی اکتشاف دارویی
پیش نمایش صفحه اول مقاله
The effect of solvent polarity on the accumulation of leachables from pharmaceutical product containers
چکیده انگلیسی

Material/water equilibrium interaction constants (Eb) 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, log Eb 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.

ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: European Journal of Pharmaceutical Sciences - Volume 27, Issues 2–3, February 2006, Pages 133–142
نویسندگان
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