Polymorphs, Salts, and Cocrystals: What's in a Name?
Polymorphs, Salts, and Cocrystals: What's in a Name?
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DOI：
10.1021/cg3002948
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发表时间：
2012-05-01
影响因子：
3.8
通讯作者：
Zaworotko, Michael J.
中科院分区：
文献类型：
--
作者：
Aitipamula, Srinivasulu;Banerjee, Rahul;Zaworotko, Michael J.
2011年12月，美国食品药品监督管理局（FDA）发布了一份关于活性药物成分（API）药物共晶监管分类的指南草案，该指南解决了晶体工程和制药科学界关注的两个问题：（1）共晶的拟议定义;（2）将药物共晶体分类为可分离的“API-赋形剂”分子复合物。由印度-美国科学技术论坛主办的题为“固态化学在制药科学中不断发展的作用”的印美双边会议于2012年2月2日至4日在印度德里附近的Manesar举行。会议的一部分专门讨论了FDA指南草案。这场辩论产生了强烈的共识，认为需要更广泛地定义共晶，并将其分类为盐。还得出结论，API晶型的多样性使得难以将固体形式分为相互排斥的三类。这一观点总结了印美双边会议的讨论，并包括未参加会议的研究人员的贡献。
The December 2011 release of a draft United States Food and Drug Administration (FDA) guidance concerning regulatory classification of pharmaceutical cocrystals of active pharmaceutical ingredients (APIs) addressed two matters of topical interest to the crystal engineering and pharmaceutical science communities: (1) a proposed definition of cocrystals; (2) a proposed classification of pharmaceutical cocrystals as dissociable "API-excipient" molecular complexes. The Indo U.S. Bilateral Meeting sponsored by the Indo-U.S. Science and Technology Forum titled The Evolving Role of Solid State Chemistry in Pharmaceutical Science was held in Manesar near Delhi, India, from February 2-4, 2012. A session of the meeting was devoted to discussion of the FDA guidance draft. The debate generated strong consensus on the need to define cocrystals more broadly and to classify them like salts. It was also concluded that the diversity of API crystal forms makes it difficult to classify solid forms into three categories that are mutually exclusive. This perspective summarizes the discussion in the Indo-U.S. Bilateral Meeting and includes contributions from researchers who were not participants in the meeting.