Polymorphs, Salts, and Cocrystals: What鈥檚 in a Name?
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- 作者：Srinivasulu Aitipamula ; Rahul Banerjee ; Arvind K. Bansal ; Kumar Biradha ; Miranda L. Cheney ; Angshuman Roy Choudhury ; Gautam R. Desiraju ; Amol G. Dikundwar ; Ritesh Dubey ; Nagakiran Duggirala ; Preetam P. Ghogale ; Soumyajit Ghosh ; Pramod Kumar Goswami ; N. Rajesh Goud ; Ram R. K. R. Jetti ; Piotr Karpinski ; Poonam Kaushik ; Dinesh Kumar ; Vineet Kumar ; Brian Moulton ; Arijit Mukherjee ; Gargi Mukherjee ; Allan S. Myerson ; Vibha Puri ; Arunachalam Ramanan ; T. Rajamannar ; C. Malla Reddy ; Nair Rodriguez-Hornedo ; Robin D. Rogers ; T. N. Guru Row ; Palash Sanphui ; Ning Shan ; Ganesh Shete ; Amit Singh ; Changquan C. Sun ; Jennifer A. Swift ; Ram Thaimattam ; Tejender S. Thakur ; Rajesh Kumar Thaper ; Sajesh P. Thomas ; Srinu Tothadi ; Venu R. Vangala ; Narayan Variankaval ; Peddy Vishweshwar ; David R. Weyna ; Michael J. Zaworotko
- 刊名：Crystal Growth & Design
- 出版年：2012
- 出版时间：May 2, 2012
- 年：2012
- 卷：12
- 期：5
- 页码：2147-2152
- 全文大小：305K
- 年卷期：v.12,no.5(May 2, 2012)
- ISSN：1528-7505
文摘
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 鈥淎PI-excipient鈥?molecular complexes. The Indo鈥揢.S. Bilateral Meeting sponsored by the Indo鈥揢.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鈥?, 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鈥揢.S. Bilateral Meeting and includes contributions from researchers who were not participants in the meeting.