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Co-crystal Parameters
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USFDA
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EMA
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| Definition |
Solids that are crystalline materials composed of two or more molecules in the same crystal lattice. |
Homogenous (single phase) crystalline structures made up of two or more components in a definite stoichiometric ratio where the arrangement in the crystal lattice is not based on ionic bonds (as with salts). |
| Regulatory status |
DPI, not regarded as a new API |
New Active Substance status depends upon demonstration of efficacy and/or safety |
| Regulatory regard |
Similar to polymorph of the same API |
Similar to salts of the same API |
| Coformers |
Neutral guest compound (excipient) |
Non-active components/Reagents (excipient) |
| Chemical interactions |
Nonionic |
Nonionic |
| Similarity with API |
Yes |
Depends upon demonstration of efficacy and/or safety |
| US-Drug master files (DMF)/EMA-Active substance master file (ASMF) |
Not feasible being DPI |
Can be filed |
| Applicable Good manufacturing practice (GMP) regulations/guide |
cGMP for drug product |
Part II of EU GMP Guide (active substances) and ICH Q7 and in rare cases Part I of EU GMP Guide (finished drug product) |
