Guiding Cocrystal Development

Cocrystals offer pharmaceutical manufacturers an alternative method to using salts or hydrates for obtaining a crystalline solid form of an API with desirable stability and dissolution behavior.

Recently, the FDA issues its final regulatory guidance on cocrystals (http://www.fda.gov/downloads/Drugs/Guidances/UCM281764.pdf).

Even though nearly all commenters requested that the FDA not classify cocrystals as 'drug product intermediates' but as salts, the agency elected to keep this definition in the final guidance.

Why were so many opposed to this approach, and what impact might the FDA’s decision to retain this classification have on the eventual acceptance of cocrystals in drug formulations?

There is significantly more information required for drug product intermediates, In addition, the decision could benefit generic companies, which may be able to use cocrystals as a means to get around patents. Thus, in the short and long term, this decision may deter branded pharmaceutical manufacturers from developing formulations based on cocrystals.

What do you think of the FDA’s final guidance on cocrystals? Will it have an impact on their further development? Or do you  think the performance benefits that can be gained in certain cases by using cocrystals will outweigh the additional testing and reporting requirements and the potential longer-term threat of generic competition?

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Cynthia Challener, PhD

Editor

The Pharmaceutical Sciences, Manufacturing & Marketplace Report