Byrn S, Pfeiffer R, Ganey M, Hoiberg C, Poochikian G
Department of Medicinal Chemistry and Pharmacognosy, Purdue University, West Lafayette, Indiana 47907, USA.
Pharm Res. 1995 Jul;12(7):945-54. doi: 10.1023/a:1016241927429.
This review describes a conceptual approach to the characterization of pharmaceutical solids.
Four flow charts are presented: (1) polymorphs, (2) hydrates, (3) desolvated solvates, and (4) amorphous forms.
These flow charts (decision trees) are suggested as tools to develop information on pharmaceutical solids for both scientific and regulatory purposes.
It is hoped that this review will lead to a more direct approach to the characterization of pharmaceutical solids and ultimately to faster approval of regulatory documents containing information on pharmaceutical solids.
本综述描述了一种用于表征药物固体的概念性方法。
展示了四个流程图：（1）多晶型物，（2）水合物，（3）去溶剂化溶剂化物，以及（4）无定形形式。
建议将这些流程图（决策树）作为工具，用于为科学和监管目的开发有关药物固体的信息。
希望本综述将带来一种更直接的方法来表征药物固体，并最终加快包含药物固体信息的监管文件的批准。
