FDA Issues Draft Guidance of Pharmaceutical Co-Crystals

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 08-24-2016 10:31


The US Food and Drug Administration has issued draft guidance, Regulatory Classification of Pharmaceutical Co-Crystals, to provide applicants planning to submit new drug applications (NDAs) and abbreviated new drug applications (ANDAs) with information on the appropriate regulatory classification of pharmaceutical co-crystal solid-state forms. The guidance also provides information about the data that applicants should submit to support the appropriate classification of a co-crystal as well as the regulatory implications of the classification.

The recommendations in this guidance apply to materials that the agency has not previously evaluated and determined to be pharmaceutical co-crystals. The recommendations do not apply to materials that the agency has previously designated as salts, complexes, or other non-co-crystalline forms.

Co-crystals are crystalline materials composed of two or more different molecules, typically drug and co-crystal formers (“coformers”), in the same crystal lattice. Pharmaceutical co-crystals have opened up opportunities for engineering solid-state forms beyond conventional solid-state forms of an active pharmaceutical ingredient (API), such as salts and polymorphs. Co-crystals can be tailored to enhance drug product bioavailability and stability and to enhance the processability of APIs during drug product manufacture. Another advantage of co-crystals is that they generate a diverse array of solid-state forms for APIs that lack ionizable functional groups, which is a prerequisite for salt formation.

Source: US Food and Drug Administration


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