Table II.
Dissolution apparatus | Paddle apparatus | Reciprocating cylinder | Flow through cell | |||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Granulation process | Kenwood | Mi-Pro | Kenwood | Mi-Pro | Kenwood | Mi-Pro | ||||||||||||||
Drug content (%) | 22 | 36 | 22 | 36 | 22 | 36 | 22 | 36 | 12.5 | 22 | 12.5 | 36 | 22 | 36 | 12.5 | 22 | 12.5 | 36 | 22 | 36 |
f1 difference factor | 21.1 | 17.4 | 7.5 | 5.5 | 16.6 | 25.5 | 13.8 | 15.9 | 32.8 | 17.4 | ||||||||||
f2 similarity factor | 36.8 | 42.9 | 59.0 | 62.3 | 40.0 | 30.6 | 49.8 | 43.7 | 25.0 | 47.1 | ||||||||||
Statistical significance | Difference | Difference | No difference | No difference | Difference | Difference | Difference | Difference | Difference | Difference |