Pharmaceutical Co-Crystals: An Overview on Synthesis and Regulatory Aspects

Co-Crystals are crystalline materials formed by bonding between a drug and co-former. This alternative approach help to overcome many issues arise during preformulation like solubility, dissolution characteristics, compressibility, and product stability. The co-crystal engineering is done by following hydrogen bonding rules and molecular structure by using Cambridge structural database. co-crystals can be synthesized by solution mediated and solvo thermal methods. The formation of the crystals was analyzed by some analytical techniques like FTIR, DSC etc. The regulation of pharmaceutical co-crystals and their formulations shows considerable effect on development and quality control strategies and also to the value of intellectual properties. Keywords: co-crystals, crystallization, Heterosynthons, stoichiometr