FDA regulation on pharmaceutical cocrystals

The cocrystals are gaining increased significance in the pharmaceutical and chemical industry in recent years. Since early 2012, the FDA (U.S. Food and Drug Administration) has issued guidelines to regulate the use of pharmaceutical cocrystals, and determines that a cocrystal should be considered as a drug product intermediate and not as a new API. This decision is of great importance since it opens the door to the use of cocrystals in the pharmaceutical industry and eliminates the need for the cocrystal to go through the vast amount of clinical trials necessary if it had been considered as a new API, paving the way to the use of cocrystals of APIs for new chemical entities and generic products.

This means that the cocrystals can be a solution to many of the problems that arise when wanting to take a drug to market: intellectual property, stability, bioavailability, etc.

For more information: Guidance for Industry about the Regulatory Classification of Pharmaceutical Co-Crystals.