Formulations of Clopidogrel Bisulphate
This invention relates to pharmaceutical tablet formulations of clopidogrel bisulphate which include glyceryl dibehenate as lubricant. The tablets are found to be very stable and to exhibit suitable dissolution characteristics.
1 . A pharmaceutical formulation comprising clopidogrel bisulphate and the lubricant glyceryl dibehenate.
2 . The formulation of claim 1 , where said formulation additionally comprises a disintegrant selected from the group consisting of starch, hydroxypropyl cellulose and crospovidone.
3 . The formulation of claim 2 , comprising as a disintegrant crospovidone.
4 . The formulation of claim 3 , wherein said crospovidone is Polyplasdone XL®.
5 . The formulation of claim 1 comprising microcrystalline cellulose.
6 . The formulation of claim 5 comprising in the range of 10 to 75 wt % microcrystalline cellulose.
7 . The formulation of claim 1 comprising lactose.
8 . The formulation of claim 7 comprising in the range of 10-75 wt % lactose anhydrous.
9 . The formulation of claim 1 comprising microcrystalline cellulose and lactose.
10 . The formulation of claim 9 comprising in the range of 10-65 wt % microcrystalline cellulose and in the range of 10-65 wt % lactose anhydrous.
11 . The formulation of claim 10 comprising in the range of 15-40 wt % microcrystalline cellulose and in the range of 15-40 wt % lactose anhydrous.
12 . The formulation of claim 1 comprising in the range of 1-5 wt % glyceryl dibehenate.
13 . The formulation of claim 1 comprising in the range of 1-5 wt % of a lubricant formulation comprising in the range of about 50-100 wt % glyceryl di- and tribehenate.
14 . The formulation of claim 1 formulated in tablet dosage form.
15 . The formulation of claim 14 , wherein said tablets are coated.
16 . The formulation of claim 14 wherein said tablets are prepared by direct compression.
17 . The formulation of claim 1 which comprises clopidogrel bisulphate, glyceryl dibehenate, crospovidone, lactose anhydrous, cellulose microcrystalline and talc.
18 . The formulation of claim 15 , wherein said tablets are prepared by direct compression.