Jenke Dennis R
Technology Resources Division, Baxter Healthcare Corporation, Round Lake, IL 60073, USA.
PDA J Pharm Sci Technol. 2005 Jul-Aug;59(4):265-81.
Establishing a link between extractables and leachables may be necessary to understand, interpret, assess, quantify, or control the interaction between a drug product and its container/closure system. This paper considers the various factors that affect the rigor with which such a linkage is established and justified. Such an assessment considers the origin and/or genesis of the leachable or extractable, enumerates situations in which extractables/leachables linkages are useful, ties such situations to the drug product's lifecycle, defines a hierarchy of linkages based on the rigor with which the linkages are established and justified, and establishes guidelines for how to determine what kind of linkage is appropriate for certain circumstances and situations. Additionally, this paper gives several examples of linkages relevant to flexible plastic drug product containers.
建立可提取物与可浸出物之间的联系对于理解、解释、评估、量化或控制药品与其容器/密封系统之间的相互作用可能是必要的。本文考虑了影响建立和证明这种联系的严谨性的各种因素。这种评估考虑了可浸出物或可提取物的来源和/或成因，列举了可提取物/可浸出物联系有用的情况，将这些情况与药品的生命周期联系起来，根据建立和证明联系的严谨程度定义了联系的层次结构，并建立了如何确定何种联系适用于特定情况和情形的指南。此外，本文给出了与柔性塑料药品容器相关的联系的几个例子。
