Table IV.
Comparison of Dissolution Profiles of the Two Types of Granules
| Dissolution apparatus | Paddle apparatus | Reciprocating cylinder | Flow through cell | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Drug content (%) | 22 | 36 | 22 | 36 | 12.5 | 22 | 36 | |||||||
| Granulation process | K | MP | K | MP | K | MP | K | MP | K | MP | K | MP | K | MP |
| f1 difference factor | 10.4 | 6.5 | 10.3 | 9.5 | 9.7 | 11.0 | 14.7 | |||||||
| f2 similarity factor | 50.9 | 67.9 | 50.4 | 56.3 | 51.3 | 54.6 | 51.4 | |||||||
| Statistical significance | No difference | No difference | No difference | No difference | No difference | No difference | No difference | |||||||
K Kenwood, MP Mi-Pro