Abstract
Cocrystal is a concept of the supramolecular chemistry which is gaining the extensive interest of researchers from pharmaceutical and chemical sciences and of drug regulatory agencies. The prominent reason of which is its ability to modify physicochemical properties of active pharmaceutical ingredients. During the development of the pharmaceutical product, formulators have to optimize the physicochemical properties of active pharmaceutical ingredients. Pharmaceutical cocrystals can be employed to improve vital physicochemical characteristics of a drug, including solubility, dissolution, bioavailability and stability of pharmaceutical compounds while maintaining its therapeutic activity. It is advantageous being a green synthesis approach for production of pharmaceutical compounds. The formation polymorphic forms, solvates, hydrates and salts of cocrystals during the synthesis reported in the literature which can be a potential issue in the development of pharmaceutical cocrystals. The approaches like hydrogen bonding rules, solubility parameters, screening through the CSD database or thermodynamic characteristics can be utilized for the rational design of cocrystals and selection of coformers for synthesis multi-component cocrystals. Considering the significance of pharmaceutical cocrystals pharmaceutical regulatory authorities in the United States and Europe issued guidance documents which may be helpful for pharmaceutical product registration in these regions. In this article, we deal with the design, synthesis, strategic aspects and characteristics of cocrystals along perspectives on its regulatory and intellectual property considerations.
Highlights
During the last few years, a plethora of drug products has reached the market
The fact reported that cocrystals could be formed during the phase transition of the lowtemperature stable polymorph of furosemide if coformer is available in close contact with the transforming component suggesting increased mass transfer rate can trigger cocrystal formation.[56]
The importance of crystal engineering through cocrystallization in pharmaceutical field can be understood by looking at regulatory cocrystal considerations and Cambridge structural database (CSD) database growth
Summary
During the last few years, a plethora of drug products has reached the market. The poorly water-soluble drug candidates are becoming more prevalent in the pharmaceutical industry (Lipinski, 2000).[1]Approximately 40% of the marketed immediate release oral products are categorized as practically insoluble (Takagi2006).[2].
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