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Research: Implications of FDA Guidance on Pharmaceutical Co-Crystals Discussed

By SSCI, Inc. | December 30, 2016

SSCI publishes co-crystal paper on the taxonomy of co-crystal ternary phase diagrams.

SSCI, a division of AMRI, announced the publication of “Taxonomy of Co-Crystal Ternary Phase Diagrams” in the Journal of Chemical & Engineering Data, authored by Dr. Richard B. McClurg, research fellow at SSCI. 

This publication follows the “Lunch and Learn” series hosted by SSCI in November and December 2016 that brought together more than 100 industry scientific experts and intellectual property leaders to discuss the implications of the latest FDA guidance on pharmaceutical co-crystals as drug substances.

The report establishes the value of using free energy surfaces as the basis of a classification system for co-crystal ternary phase diagrams. The three components in each diagram are the active pharmaceutical ingredient (API), coformer, and solvent. In addition to topologically distinct diagrams, phase diagrams are distinguished as to the congruent or incongruent dissolution of the co-crystalline phase. The diagrams are organized according to the set of solid phases and the number of three-phase regions. Phase diagrams and free energy surfaces are provided for representative examples of each illustrated case.

“The research contribution made by Dr. McClurg is yet another example of SSCI’s commitment to helping the industry gain a better understanding of co-crystals,” said Dr. David Engers, senior director and site head at SSCI. “Our full-suite of proprietary and patented methods for preparing and characterizing co-crystals allow SSCI scientists to solve the solid-state chemistry problems that arise during development of co-crystals, to create valuable intellectual property for our clients.”

McClurg added that, “The diversity of co-crystal phase diagrams classified in the report is much richer than many practitioners in the field would expect, particularly for solvated co-crystals. Being aware of these possibilities aids in the characterization of our clients’ systems of interest.”

SSCI provides contract solid-state and analytical testing services to help companies in the pharmaceutical, food, agrochemical, and other chemical industries develop better products and get them to market more quickly. www.ssci-inc.com.

(Source: PRWeb)

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