Table 6.
Results of the stability measurements after 49 days of storage at a defined RH. Checkmarks indicate that the prepared CC was still present after 49 days of storage and transformation could not be detected. Xs represent the formation of a CC anhydrate or CF as indicated. Circles show samples containing more than 2% water after 49 days of storage. Shaded regions in the table indicate samples/conditions for which deliquescence was predicted.
| CC | Add. Crystals | Excipient | RH/% | |||||
|---|---|---|---|---|---|---|---|---|
| 0 | 58 | 76 | 86 | 93 | 98 | |||
| (SA/NA) | SA | - | ✓ | - | ✓ | ✓ | ✓ | ✓ |
| (urea/GA 2:1) | - | - | ✓ | - | ✓ | ✓ | ✓ | ✓◯ |
| (urea/GA 1:1) | 2:1 CC | - | ✓ | - | ✓ | ✓ | ✓◯ | ✓◯ |
| (CBZ/NA) | NA | - | ✓ | - | ✓ | ✓ | ✓ | ✓◯ |
| (TP/CA) hydrate | CA | - | ✓ | - | ✘ CC anhydr. | ✓◯ | ✓◯ | ✓◯ |
| (SA/NA) | SA | fructose | ✓ | ✓ | ✘◯ NA | - | - | - |
| (CBZ/NA) | NA | fructose | ✓ | ✓ | ✓◯ | - | - | - |
| (TP/CA) hydrate | CA | fructose | ✓ | ✓◯ | ✓◯ | - | - | - |
| (SA/NA) | SA | xylitol | ✓ | ✓ | ✓ | ✓◯ | - | - |
| (CBZ/NA) | NA | xylitol | ✓ | ✓ | - | ✓◯ | - | - |
| (TP/CA) hydrate | CA | xylitol | ✓ | ✓◯ | ✓◯ | ✓◯ | - | - |