Table I.
Formulation no. | F1 | F2 | F3 | F4 | F5 | F6 | F7 | F8 | F9 | F10 | F11 | F12 | F13 | F14 | F15 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Ingredients | Quantity in mg per tablet | ||||||||||||||
Fast-release coat | |||||||||||||||
Zolpidem tartrate | 6. 25 | 6.25 | 6.25 | 6.50 | 6.50 | 6. 25 | 6.25 | 6.25 | 6.50 | 6.25 | 6. 25 | 6.25 | 6.25 | 6.50 | 6.50 |
SSG | 8.40 | 8.40 | 8.40 | 8.40 | 10.5 | 8.40 | 8.40 | 8.40 | 8.40 | 10.5 | 8.40 | 8.40 | 8.40 | 8.40 | 10.5 |
PH 102 | 90 | 90 | 90 | 90 | 90 | 90 | 90 | 90 | 90 | 90 | 90 | 90 | 90 | 90 | 90 |
LubriTose AN | 105.35 | 105.35 | 105.35 | 105.10 | 103 | 105.35 | 105.35 | 105.35 | 105.10 | 103 | 105.35 | 105.35 | 105.35 | 105.10 | 103 |
Total weight | 210 | 210 | 210 | 210 | 210 | 210 | 210 | 210 | 210 | 210 | 210 | 210 | 210 | 210 | 210 |
Slow-release core | |||||||||||||||
Zolpidem tartrate | 6.25 | 6.25 | 6.25 | 6.00 | 6.00 | 6.25 | 6.25 | 6.25 | 6.00 | 6.00 | 6.25 | 6.25 | 6.25 | 6.00 | 6.00 |
HPMC K100M | 7 | 14 | 10.5 | 10.5 | 10.5 | – | – | – | – | – | – | – | – | – | – |
HPMC K15M | – | – | – | – | – | 7 | 14 | 10.5 | 10.5 | 10.5 | – | – | – | – | – |
HPMC K4M | – | – | – | – | – | – | – | – | – | – | 7 | 14 | 10.5 | 10.5 | 10.5 |
Lactose monohydrate | 50 | 43 | 46.5 | 46.75 | 46.75 | 50 | 43 | 46.5 | 46.75 | 46.75 | 50 | 43 | 46.5 | 46.75 | 46.75 |
Tartaric acid | 6 | 6 | 6 | 6 | 6 | 6 | 6 | 6 | 6 | 6 | 6 | 6 | 6 | 6 | 6 |
Magnesium stearate | 0.75 | 0.75 | 0.75 | 0.75 | 0.75 | 0.75 | 0.75 | 0.75 | 0.75 | 0.75 | 0.75 | 0.75 | 0.75 | 0.75 | 0.75 |
Total weight | 70 | 70 | 70 | 70 | 70 | 70 | 70 | 70 | 70 | 70 | 70 | 70 | 70 | 70 | 70 |
Total weight of press-coated tablet | 280 | 280 | 280 | 280 | 280 | 280 | 280 | 280 | 280 | 280 | 280 | 280 | 280 | 280 | 280 |