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Polymorphs, Salts, and Cocrystals: What's in a Name?

Aitipamula, Srinivasulu and Banerjee, Rahul and Bansal, Arvind K and Biradha, Kumar and Cheney, Miranda L and Choudhury, Angshuman Roy and Desiraju, Gautam R and Dikundwar, Amol G and Dubey, Ritesh and Duggirala, Nagakiran and Ghogale, Preetam P and Ghosh, Soumyajit and Goswami, Pramod Kumar and Goud, Rajesh N and Jetti, Ram RKR and Karpinski, Piotr and Kaushik, Poonam and Kumar, Dinesh and Kumar, Vineet and Moulton, Brian and Mukherjee, Arijit and Mukherjee, Gargi and Myerson, Allan S and Puri, Vibha and Ramanan, Arunachalam and Rajamannar, T and Reddy, Malla C and Rodriguez-Hornedo, Nair and Rogers, Robin D and Row, Guru TN and Sanphui, Palash and Shan, Ning and Shete, Ganesh and Singh, Amit and Sun, Changquan C. and Swift, Jennifer A. and Thaimattam, Ram and Thakur, Tejender S and Thaper, Rajesh Kumar and Thomas, Sajesh P and Tothadi, Srinu and Vangala, Venu R and Variankaval, Narayan and Vishweshwar, Peddy and Weyna, David R and Zaworotko, Michael J (2012) Polymorphs, Salts, and Cocrystals: What's in a Name? In: CRYSTAL GROWTH & DESIGN, 12 (5). pp. 2147-2152.

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Official URL: http://dx.doi.org/10.1021/cg3002948

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.

Item Type: Journal Article
Additional Information: Copyright for this article belongs to American Chemical Society
Department/Centre: Division of Chemical Sciences > Solid State & Structural Chemistry Unit
Date Deposited: 14 Jul 2012 06:41
Last Modified: 31 Dec 2012 10:34
URI: http://eprints.iisc.ernet.in/id/eprint/44588

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