Morris K R, Griesser U J, Eckhardt C J, Stowell J G
Department of Industrial and Physical Pharmacy, Purdue University, West Lafayette, IN 47907-1336, USA.
Adv Drug Deliv Rev. 2001 May 16;48(1):91-114. doi: 10.1016/s0169-409x(01)00100-4.
Processing-induced transformations (PITs) during pharmaceutical manufacturing are well known but difficult to predict and often difficult to control. This review of the concepts of transformations is couched in terms of the issues associated with identifying rate-controlling events from the materials side and the processing side. Specifically, the approach is reconciling the characteristic time scale of the structural change(s) in the material with the time scale of the processing-induced stress. This is definitely a model (or rather a melding of a group of existing theories) in development. This overview is a 'snapshot' of the authors' attempts to identify the categories of existing theories needed to encompass all of the relevant events for each possible PIT. The ultimate goal is to establish a framework of concepts and theories for consideration, discussion, and modeling of PITs as well as to locate much of the relevant literature in the framework.
药物制造过程中的加工诱导转变（PITs）是众所周知的，但难以预测且往往难以控制。本文对转变概念的综述是围绕与从物料方面和加工方面识别速率控制事件相关的问题展开的。具体而言，该方法是将物料结构变化的特征时间尺度与加工诱导应力的时间尺度进行协调。这无疑是一个正在发展中的模型（或者更确切地说是一组现有理论的融合）。本综述是作者尝试识别涵盖每种可能的PIT所有相关事件所需的现有理论类别的“快照”。最终目标是建立一个用于思考、讨论和模拟PITs的概念和理论框架，并在该框架中定位大量相关文献。
