Pharmaceutical tablets of crystalline type II aripiprazole

1. A pharmaceutical composition in the form of a tablet, comprising 1 to 50 mg of aripiprazole Type II and pharmaceutically acceptable excipients, said excipients including (a) one or more polyol fillers, (b) one or more binders, (c) one or more disintegrants, and (d) a lubricant.

2. The composition according to claim 1 , wherein said aripiprazole has a particle size distribution such that the d 90 is not greater than 50 microns.

3. The composition according to claim 2 , wherein said aripiprazole is unmilled.

4. The composition according to claim 1 , wherein said tablet is made by wet granulation.

5. The composition according to claim 1 , wherein said polyol filler (a) is selected from lactose, sorbitol, mannitol, and combinations thereof.

6. The composition according to claim 5 , wherein said polyol filler (a) is lactose monohydrate.

7. The composition according to claim 5 , wherein said polyol filler (a) is contained in the greatest amount of said pharmaceutically acceptable excipients.

8. The composition according to claim 1 , wherein said binder (b) comprises microcrystalline cellulose, hydroxypropyl cellulose or combinations thereof.

9. The composition according to claim 8 wherein said disintegrant (c) is sodium starch glycolate and said lubricant (d) is magnesium stearate.

10. The composition according to claim 9 , wherein said polyol filler (a) is lactose monohydrate.

11. An aripiprazole pharmaceutical tablet made by a process, which comprises:

wet granulating aripiprazole Type II with pharmaceutically acceptable excipients including (a) one or more polyol fillers, (b) one or more binders, and (c) one or more disintegrants to form a granulate;

mixing said granulate with one or more additional pharmaceutically acceptable excipient(s) including at least (d) a lubricant to form a tablet blend; and

compressing said tablet blend to form an aripiprazole pharmaceutical tablet.

12. The aripiprazole tablet according to claim 11 , wherein said one or more additional pharmaceutically acceptable excipients in said mixing step further includes one or more disintegrants.

13. The aripiprazole tablet according to claim 12 , wherein said granulate comprises:

Aripiprazole Type II

 5-20%

Sodium starch glycolate

1-6%

Microcrystalline cellulose

 0-25%

Lactose monohydrate

30-80%

Hydroxylpropyl cellulose

 0-20%

and wherein said additional pharmaceutically acceptable excipients comprise:

Sodium starch glycolate

  1-6%

Magnesium stearate

0.5-3%

and wherein said percentages are based on the total weight of the aripiprazole tablet.

14. The aripiprazole tablet according to claim 11 , wherein said aripiprazole Type II used in said wet granulating step was not milled and has a d 90 of 50 microns or less.

15. The aripiprazole tablet according to claim 13 , wherein said aripiprazole Type II used in said wet granulating step was not milled and has a d 90 of 50 microns or less.

16. The composition according to claim 1 , wherein said disintegrant (c) is selected from sodium starch glycolate, crosspovidone, crosscarmelose sodium, and combinations thereof.

17. The composition according to claim 1 , wherein said pharmaceutically acceptable excipients consist essentially of (a) a filler selected from lactose, sorbitol, mannitol, and combinations thereof; (b) a binder selected from microcrystalline cellulose, hydroxypropyl cellulose, and combinations thereof; (c) a disintegrant selected from sodium starch glycolate, crosspovidone, crosscarmelose sodium and combinations thereof; and (d) a lubricant.