Polymorphs, salts, and cocrystals: What's in a name?

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 MoultonArijit 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

Research output: Contribution to journalReview article

430 Scopus citations

Abstract

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.

Original languageEnglish (US)
Pages (from-to)2147-2152
Number of pages6
JournalCrystal Growth and Design
Volume12
Issue number5
DOIs
StatePublished - May 2 2012

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