What is the impact of recent changes in FDA guidance on regulatory and intellectual property issues?
Shawn Comella
Global Leaders in Solid-State Chemical Development and Materials Characterization
WHITEPAPER: Cocrystals: A Regulatory Rebirth
Pat Stahly, Ph.D.
The FDA reclassification of cocrystals as active pharmaceutical ingredients (APIs) has created exciting opportunities for the pharmaceutical industry. That reclassification means cocrystals can now be developed as if they were polymorphs, providing new avenues for dealing with poor API physical properties and extending intellectual property lifetimes. It is important to understand how the revised guideline impacts API development, regulatory submissions, and intellectual property protection. Those topics are discussed in this whitepaper. Also considered is the importance of identifying whether an API is a salt or a cocrystal, a critical classification from a regulatory point of view. In addition, a list of FDA-approved, marketed cocrystals is presented. Finally, recommendations for cocrystal screening, evaluation, formulation, and production at scale are given.
https://tricliniclabs.com/directory/solid-state-development-services/physical-and-analytical-chemistry/cocrystal-co-crystal-screening-selection-formulation-development-for-pharmaceutical-property-improvement.html
Principal Scientist | Solid-form screening | Solubility Enabling Technologies | Preformulation, small molecules | Salt | Cocrystal | Polymorphism | Physical characterisation | Raman Spectroscopy | IPR
7 年In deed, interesting. Thank you
VP Business Development at Evotec for contract API, drug product, preclinical development and integrated INDiGO IND packages inclusive of all three.
7 年Thanks for the update.
CMC, Reg Affairs, and Quality Assurance
7 年Interesting