Jenke Dennis, Couch Tom, Gillum Amy
Baxter Healthcare Corporation, Route 120 and Wilson Road, Round Lake, IL 60073.
PDA J Pharm Sci Technol. 2010 Jan-Feb;64(1):37-43.
Material/water equilibrium binding constants (E(b)) were determined for 11 organic solutes and 2 plastic materials commonly used in pharmaceutical product containers (plasticized polyvinyl chloride and polyolefin). In general, solute binding by the plasticized polyvinyl chloride material was greater, by nearly an order of magnitude, than the binding by the polyolefin (on an equal weight basis). The utilization of the binding constants to facilitate container compatibility assessments (e.g., drug loss by container binding) for drug-containing products is discussed.
测定了11种有机溶质与2种常用于药品容器的塑料材料(增塑聚氯乙烯和聚烯烃)之间的材料/水平衡结合常数(E(b))。一般来说,增塑聚氯乙烯材料对溶质的结合力比聚烯烃(按等重量计算)大近一个数量级。文中讨论了如何利用这些结合常数来促进对含药产品的容器相容性评估(例如,因容器结合导致的药物损失)。