Pharmaceutical compositions comprising levetiracetam and process for their preparation

1. A pharmaceutical composition comprising levetiracetam as active ingredient and

2.0 to 9.0% per weight of a disintegrant selected from polyvinylpolypyrrolidone and sodium croscarmellose,

0.0 to 3.0% per weight of gliding agent,

0.5 to 6.0% per weight of binder selected from macrogol, microcrystalline cellulose, saccharose, mannitol, and sorbitol, and

0.0 to 1.0% per weight of lubricant,

with respect to the total weight of the pharmaceutical composition.

2. The pharmaceutical composition according to claim 1 comprising 3.0 to 7.0% per weight of disintegrant with respect to the total weight of the pharmaceutical composition.

3. The pharmaceutical composition according to claim 1 comprising 0.5 to 2.5% per weight of gliding agent with respect to the total weight of the pharmaceutical composition.

4. The pharmaceutical composition according to claim 1 comprising 0.5 to 4.0% per weight of binder with respect to the total weight of the pharmaceutical composition.

5. The pharmaceutical composition according to claim 1 comprising 0.8 to 1.6% per weight of binder with respect to the total weight of the pharmaceutical composition.

6. The pharmaceutical composition according to claim 1 comprising 0.0 to 0.75% per weight of lubricant with respect to the total weight of the pharmaceutical composition.

7. The pharmaceutical composition according to claim 1 comprising 0.0 to 0.50% per weight of lubricant with respect to the total weight of the pharmaceutical composition.

8. The pharmaceutical composition according to claim 1 comprising 0.08 to 0.15% per weight of lubricant with respect to the total weight of the pharmaceutical composition.

9. The pharmaceutical composition according to claim 1 wherein the sum of disintegrant, gliding agent, binder and lubricant is less than or equal to 20% per weight with respect to the total weight of the pharmaceutical composition.

10. The pharmaceutical composition according to claim 1 wherein the disintegrant is sodium croscarmellose.

11. The pharmaceutical composition according to claim 1 wherein the gliding agent is anhydrous colloidal silica.

12. The pharmaceutical composition according to claim 1 wherein the binder is polyethylene glycol 6000.

13. The pharmaceutical composition according to claim 1 wherein the lubricant is magnesium stearate.

14. The pharmaceutical composition according to claim 1 comprising 2.0 to 9.0% per weight of sodium croscarmellose with respect to total weight of the pharmaceutical composition.

15. The pharmaceutical composition according to claim 1 comprising 0.0 to 3.0% per weight of anhydrous colloidal silica with respect to total weight of the pharmaceutical composition.

16. The pharmaceutical composition according to claim 1 comprising 0.5 to 6.0% per weight of polyethylene glycol 6000 with respect to total weight of the pharmaceutical composition.

17. The pharmaceutical composition according to claim 1 comprising 0.0 to 1.0% per weight of magnesium stearate with respect to total weight of the pharmaceutical composition.

18. The pharmaceutical composition according to claim 1 which comprises 80% to 95% per weight of levetiracetam.

19. The pharmaceutical composition according to claim 1 which comprises a coating agent.

20. The pharmaceutical composition according to claim 19 wherein the coating agent comprises polyvinyl alcohol.

21. The pharmaceutical composition according to claims 19 wherein the coating agent is hydroxypropylmethylcellulose aqueous dispersions.

22. The pharmaceutical composition according to claim 1 which is a tablet.

23. A process of manufacturing a pharmaceutical composition comprising levetiracetam as active ingredient and

2.0 to 9.0% per weight of a disintegrant selected from polyvinylpolypyrrolidone and sodium croscarmellose,

0 to 3.0% per weight of gliding agent,

0.5 to 6.0% per weight of a binder selected from macrogol, microcrystalline cellulose, saccharose, mannitol, and sorbitol, and

0.0 to 1.0% per weight of lubricant,

with respect to the total weight of the pharmaceutical composition,

which process comprises:

i) mixing levetiracetam, the gliding agent, the disintegrant and the binder,

ii) adding the lubricant,

iii) mixing levetiracetam, the gliding agent, the disintegrant, the binder and the lubricant;

iv) compacting the mixture obtained in iii),

v) grinding the mixture obtained in iv), and

vi) compressing the mixture obtained in v).

24. The pharmaceutical composition according to claim 1 comprising 250 mg of levetiracetam, 10.75 mg of sodium croscarmellose, 5.188 mg of anhydrous colloidal silica, 2.50 mg of polyethylene glycol 6000, and 0.313 of magnesium stearate.

25. The pharmaceutical composition according to claim 1 comprising 500 mg of levetiracetam, 21.50 mg of sodium croscarmellose, 10.375 mg of anhydrous colloidal silica, 5.00 mg of polyethylene glycol 6000, and 0.625 of magnesium stearate.

26. A pharmaceutical composition made according to the process of claim 23 .

27. The pharmaceutical composition according to claim 26 wherein the disintegrant is sodium croscarmellose.

28. The pharmaceutical composition according to claim 26 wherein the gliding agent is anhydrous colloidal silica.

29. The pharmaceutical composition according to claim 26 wherein the lubricant is magnesium stearate.

30. The pharmaceutical composition according to claim 27 comprising 2.0 to 9.0% per weight of sodium croscarmellose with respect to total weight of the pharmaceutical composition.

31. The pharmaceutical composition according to claim 28 comprising 0.0 to 3.0% per weight of anhydrous colloidal silica with respect to total weight of the pharmaceutical composition.

32. The pharmaceutical composition according to claim 29 comprising 0.0 to 1.0% per weight of magnesium stearate with respect to total weight of the pharmaceutical composition.

33. The pharmaceutical composition according to claim 26 comprising 250 mg of levetiracetam, 10.75 mg of sodium croscarmellose, 5.188 mg of anhydrous colloidal silica, 2.50 mg of polyethylene glycol 6000, and 0.313 of magnesium stearate.

34. The pharmaceutical composition according to claim 26 comprising 500 mg of levetiracetam, 21.50 mg of sodium croscarmellose, 10.375 mg of anhydrous colloidal silica, 5.00 mg of polyethylene glycol 6000, and 0.625 of magnesium stearate.

35. The pharmaceutical composition according to claim 1 comprising 750 mg of levetiracetam, 32.25 mg of sodium croscarmellose, 15.563 mg of anhydrous colloidal silica, 7.50 mg of polyethylene glycol 6000, and 24.188 of magnesium stearate.

36. The pharmaceutical composition according to claim 1 comprising 1000 mg of levetiracetam, 43.00 mg of sodium croscarmellose, 20.75 mg of anhydrous colloidal silica, 10.00 mg of polyethylene glycol 6000, and 32.25 of magnesium stearate.