Table 4.
Pharmacotechnical properties of various ASAQ monolayer and bilayer tablet formulations
| 30154C01 | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Batch n° | 20454 | 30411 | 30412 | 30436 | 30437 | 30438 | 30439 | layer AQ | layer AS | |
| Formulation | tablet | monolayer | bilayer | |||||||
| granulation | wet aq. | dry | ||||||||
| Blend control | Flowability (s/100 g) | 5 | 6 | 9 | 11 | 11 | 7 | 11 | NA | NA |
| Hausner index (Vo/Vf) | 1.25 | 1.19 | 1.21 | 1.23 | 1.10 | 1.20 | 2.24 | 1.09 | 1.41 | |
| Tablet control | Mass (mg) | 589.2 | 622.6 | 636.7 | 623.4 | 622.6 | 613.8 | 624 | 434.5 | 265.5 |
| 700 | ||||||||||
| Hardness (N) | 61 | 80 | 63 | 78 | 68 | 74 | 71 | 46 | ||
| Friability (%) | 1.50 | 1.27 | 1.39 | 1.80 | 2.55 | 2.23 | 1.79 | 0.31 | ||
| Residual humidity (%) | 6 | ND* | ND** | 1.84 | 1.44 | 1.19 | 1.07 | 1.49 | 1.31 | |
| Disintegration (min) | 3.0 | 1.8 | 1.6 | 1.5 | 1.4 | 6.1 | 4.1 | < 1.5 | ||
Key: NA: data not available
*Residual humidity not determined, Karl Fischer water content 6.35%.
** Residual humidity not determined, Karl Fischer water content 6.33%.