Table 9. .
Compositions and tableting properties of ODTs.
| Ingredients | ODT – CR 3 | ODT – CR 4 | ||||
|---|---|---|---|---|---|---|
| % per tablet | Qty/batch | % per tablet | Qty/batch | |||
| Melperone SR beads | 35.71 | 3571.4 g | 29.76 | 2976.2 g | ||
| Rapidly dispersing granules | 42.94 | 4293.6 g | 48.64 | 4863.8 g | ||
| MCC – Ceolus KG-802 | 7.50 | 750.0 g | 7.50 | 750.0 g | ||
| MCC – Avicel PH101 | 7.50 | 750.0 g | 7.50 | 750.0 g | ||
| Crospovidone (XL-10) | 5.00 | 500.0 g | 5.00 | 500.0 g | ||
| Silicon dioxide | – | 0.25 | 25.0 g | |||
| Sucralose | 0.35 | 35.0 | 0.35 | 35.0 g | ||
| Peppermint flavor | 1.00 | 100.0 | 1.00 | 100.0 | ||
| Magnesium stearate | Trace | Trace | Trace | Trace | ||
| Properties | ODT – CR 3 | ODT – CR 4 | ||||
| Compression Force | 15 kN | 16 kN | 17 kN | 13 kN | 14 kN | 15 kN |
| Tablet Weight (mg) | 1013 | 1002 | 1014 | 1203 | 1202 | 1206 |
| Tablet Hardness (N) | 39 | 42 | 49 | 48 | 57 | 63 |
| Tablet Friability (%) | 0.39 | 0.34 | 0.25 | 0.56 | 0.44 | 0.40 |