Formulating the API

The main objectives in tablet characterization are to identify drug-excipients interactions, quantitation of the amount of active substance per tablet, to identify the solid form present and to observe changes with storage conditions (stability). All of these findings, taking into account that in tablet formulations the API concentration can be very low and the signals of excipients usually dominate the spectrum, make SSNMR characterization a challenge. 

Effective patenting of co-crystals focuses primarily on two considerations (1) the characterization and proof of actual co-crystal and (2) the properties of the co-crystal. The first is perhaps more important than the second, although as discussed above, the co-crystal must possess practical utility and usefulness. That practical utility is often directly related to the properties of the co-crystal and, sometimes, even the existence of the co-crystal, as a solid-state form of the API, solves the problem of handling, processing, and/or formulating the API. 

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