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 RKR 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, TN 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
发表日期
2012/5/2
期刊
Crystal growth & design
卷号
12
期号
5
页码范围
2147-2152
出版商
American Chemical Society
简介
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 …
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