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Claims for Patent: 9,326,945

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Claims for Patent: 9,326,945

Title:Apixaban formulations
Abstract: Compositions comprising crystalline apixaban particles having a D.sub.90 equal to or less than 89 .mu.m, and a pharmaceutically acceptable carrier, are substantially bioequivalent and can be used to for the treatment and/or prophylaxis of thromboembolic disorders.
Inventor(s): Patel; Jatin (West Windsor, NJ), Frost; Charles (Yardley, PA), Jia; Jingpin (Belle Mead, NJ), Vemavarapu; Chandra (Hillsborough, NJ)
Assignee: Bristol-Myers Squibb Company (Princeton, NJ) Pfizer Inc. (New York, NY)
Application Number:13/579,796
Patent Claims: 1. A solid pharmaceutical composition comprising a therapeutically effective amount of crystalline apixaban particles and a pharmaceutically acceptable diluent or carrier, wherein the crystalline apixaban particles have a D.sub.90 equal to or less than about 89 .mu.m, and wherein at least 77 wt % of apixaban dissolves within 30 minutes in a pH 6.8 phosphate buffer containing 0.05% sodium lauryl sulfate.

2. The composition as defined in claim 1, wherein said composition comprises Form N-1 of apixaban.

3. The composition as defined in claim 1, wherein the D.sub.90 is equal to or less than 85 .mu.m.

4. The composition as defined in claim 1, wherein the D.sub.90 is equal to or less than 50 .mu.m.

5. The composition as defined in claim 1, wherein the D.sub.90 is equal to or less than 30 .mu.m.

6. The composition as defined in claim 1, wherein the D.sub.90 is equal to or less than 25 .mu.m.

7. The composition as defined in claim 1, further comprising: from 1% to 2% by weight of a surfactant.

8. The composition as defined in claim 7, wherein the surfactant is sodium lauryl sulfate.

9. The composition as defined in claim 1, wherein the pharmaceutical composition comprises from about 2.5 mg to about 5 mg of apixaban.

10. The composition as defined in claim 1, wherein the pharmaceutical composition comprises 2.5 mg of apixaban.

11. The composition as defined in claim 1, wherein the pharmaceutical composition comprises 5 mg of apixaban.

12. A solid pharmaceutical composition comprising a therapeutically effective amount of apixaban and a pharmaceutically acceptable diluent or carrier, wherein apixaban comprises crystalline apixaban particles, wherein the crystalline apixaban particles have a D.sub.90 equal to or less than about 89 .mu.m, and wherein, as measured using a USP Apparatus 2 at a paddle rotation speed of 75 rpm in 900 mL, of a dissolution medium at 37.degree. C., at least 77 wt % of apixaban in the pharmaceutical composition dissolves within 30 minutes in the dissolution medium, and the dissolution medium is 0.05 M sodium phosphate at a pH 6.8 containing 0.05% sodium lauryl sulfate.

13. The composition as defined in claim 12, wherein said composition comprises Form N-1 of apixaban.

14. The composition as defined in claim 12, wherein the D.sub.90 is equal to or less than 85 .mu.m.

15. The composition as defined in claim 12, wherein the D.sub.90 is equal to or less than 50 .mu.m.

16. The composition as defined in claim 12, wherein the D.sub.90 is equal to or less than 30 .mu.m.

17. The composition as defined in claim 12, wherein the D.sub.90 is equal to or less than 25 .mu.m.

18. The composition as defined in claim 12, further comprising: from 1% to 2% by weight of a surfactant.

19. The composition as defined in claim 18, wherein the surfactant is sodium lauryl sulfate.

20. The composition as defined in claim 12, wherein the pharmaceutical composition comprises from about 2.5 mg to about 5 mg of apixaban.

21. The composition as defined in claim 12, wherein the pharmaceutical composition comprises 2.5 mg of apixaban.

22. The composition as defined in claim 12, wherein the pharmaceutical composition comprises 5 mg of apixaban.

23. The composition as defined in claim 1, which is a tablet.

24. The composition as defined in claim 1, which is a capsule.

25. The composition as defined in claim 9, which is a tablet.

26. The composition as defined in claim 9, which is a capsule.

27. The composition as defined in claim 10, which is a tablet.

28. The composition as defined in claim 10, which is a capsule.

29. The composition as defined in claim 11, which is a tablet.

30. The composition as defined in claim 11, which is a capsule.

31. The composition as defined in claim 12, which is a tablet.

32. The composition as defined in claim 12, which is a capsule.

33. The composition as defined in claim 20, which is a tablet.

34. The composition as defined in claim 20, which is a capsule.

35. The composition as defined in claim 21, which is a tablet.

36. The composition as defined in claim 21, which is a capsule.

37. The composition as defined in claim 22, which is a tablet.

38. The composition as defined in claim 22, which is a capsule.
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