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Shaikh, Rahamatullah; Singh, Ravendra; Walker, Gavin M.; Croker, Denise M.
Trends in pharmacological sciences (Regular ed.), December 2018, 2018-12-00, 20181201, Volume: 39, Issue: 12Journal Article
Active pharmaceutical ingredients (APIs) are most commonly formulated and delivered to patients in the solid state. Recently, an alternative API solid-state form, namely the pharmaceutical cocrystal, has witnessed increasing academic and industrial interest due to its potential to deliver bespoke physical properties in the pharmaceutical drug product. This interest has been supported by advances in cocrystal discovery, development, and approval, enabled primarily by a supportive new FDA guidance in February 2018. In this review, we describe the process of developing a pharmaceutical cocrystal drug product from screening to approval, with an emphasis on significant developments over the past decade. Cocrystallization is a promising emerging option to improve the physicochemical solid-state properties of APIs, such as solubility, dissolution rate, stability, and tabletability, to develop better medicines. Cocrystals provide a unique opportunity for challenging APIs to make the transition to commercial drug products with relatively low risk and high return on investment. Cocrystals have been researched over the past few decades, yet only a few cocrystals products are commercially available. Manufacture of cocrystals has been demonstrated through established pharmaceutical industry processes (solution crystallization) and novel alternative methods (mechanochemical approaches). The latest FDA draft guidance on cocrystals, which recognizes cocrystals as drug substances, provides an excellent opportunity for drug manufacturers to develop commercial formulations of cocrystals.
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