Adv Pharm Bull. 2016;6(4):479-494.
doi: 10.15171/apb.2016.062
PMID: 28101455
PMCID: PMC5241406
Scopus id: 85011371133
  Abstract View: 670
  PDF Download: 468

Review Article

Pharmaceutical Cocrystals: Regulatory and Strategic Aspects, Design and Development

Dipak Dilip Gadade 1 * , Sanjay Sudhakar Pekamwar 1 * ORCiD

1 School of Pharmacy, S.R.T.M. University, Vishnupuri, Nanded – 431606, India.


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.
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Submitted: 31 Aug 2016
Revised: 21 Oct 2016
Accepted: 24 Oct 2016
First published online: 22 Dec 2016
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