1. Polymorphs, Salts, andCocrystals: Whatâs in a Name?
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Aitipamula, Srinivasulu, Banerjee, Rahul, Bansal, Arvind K., Biradha, Kumar, Cheney, Miranda L., Choudhury, Angshuman Roy, Desiraju, Gautam R., Dikundwar, Amol G., Dubey, Ritesh, Duggirala, Nagakiran, Ghogale, Preetam P., Ghosh, Soumyajit, Goswami, Pramod Kumar, Goud, N. Rajesh, Jetti, Ram R. K. R., Karpinski, Piotr, Kaushik, Poonam, Kumar, Dinesh, Kumar, Vineet, and Moulton, Brian
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POLYMORPHISM (Crystallography) , *SALTS , *CRYSTAL growth , *PHARMACEUTICAL chemistry , *SOLID state chemistry - 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 âAPI-excipientâ molecular complexes. The IndoâU.S. Bilateral Meeting sponsored by the IndoâU.S. Science and Technology Forum titled The Evolving Role of Solid State Chemistry in Pharmaceutical Sciencewas held in Manesar near Delhi, India, from February 2â4, 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 IndoâU.S. Bilateral Meeting and includes contributions from researchers who were not participants in the meeting. [ABSTRACT FROM AUTHOR]
- Published
- 2012
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