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Claims for Patent: 8,455,536

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Claims for Patent: 8,455,536

Title:Methods of using (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoi- soindoline 1,3-dione
Abstract: Stereomerically pure (+)-2-[1-(3-Ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoi- soindoline-1,3-dione, substantially free of its (-) isomer, and prodrugs, metabolites, polymorphs, salts, solvates, hydrates, and clathrates thereof are discussed. Also discussed are methods of using and pharmaceutical compositions comprising the (+) enantiomer of 2-[1-(3-Ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoin- doline-1,3-dione are disclosed. The methods include methods of treating and/or preventing disorders ameliorated by the reduction of levels of TNF-.alpha. or the inhibition of PDE4.
Inventor(s): Muller; George W. (Rancho Santa Fe, CA), Schafer; Peter H. (Somerset, NJ), Man; Hon-Wah (Princeton, NJ), Ge; Chuansheng (Belle Mead, NJ)
Assignee: Celgene Corporation (Summit, NJ)
Application Number:12/630,788
Patent Claims: 1. A method of treating psoriasis, which comprises orally administering to a patient having psoriasis about 10 mg to about 200 mg per day of stereomerically pure (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoi- soindoline-1,3-dione, wherein the compound is administered in the form of a tablet or capsule as either a single dose or a divided dose.

2. The method of claim 1, wherein about 10 mg to about 100 mg of the compound is administered per day.

3. The method of claim 1, wherein the compound is administered twice daily in equally divided doses.

4. The method of claim 1, wherein the stereomerically pure compound comprises greater than about 90% by weight of (+) isomer based on the total weight percent of the compound.

5. The method of claim 1, wherein the stereomerically pure compound comprises greater than about 95% by weight of (+) isomer based on the total weight percent of the compound.

6. The method of claim 1, wherein the stereomerically pure compound comprises greater than about 97% by weight of (+) isomer based on the total weight percent of the compound.

7. The method of claim 1, wherein the compound is administered in capsule form.

8. The method of claim 7, wherein the capsule contains about 10 mg of the compound.

9. The method of claim 7, wherein the capsule contains about 20 mg of the compound.

10. The method of claim 7, wherein the capsule contains about 25 mg of the compound.

11. The method of claim 7, wherein the capsule contains about 50 mg of the compound.

12. The method of claim 11, wherein the compound is administered in tablet form.

13. The method of claim 12, wherein the tablet contains about 10 mg of the compound.

14. The method of claim 12, wherein the tablet contains about 20 mg of the compound.

15. The method of claim 12, wherein the tablet contains about 25 mg of the compound.

16. The method of claim 12, wherein the tablet contains about 50 mg of the compound.

17. A method of treating rheumatoid arthritis, which comprises administering to a patient having rheumatoid arthritis a therapeutically effective amount of stereomerically pure (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoi- soindoline-1,3-dione.

18. The method of claim 17, wherein the compound is administered orally.

19. The method of claim 18, wherein about 5 mg to about 500 mg of the compound is administered per day.

20. The method of claim 18, wherein about 10 mg to about 200 mg of the compound is administered per day.

21. The method of claim 18, wherein about 10 mg to about 100 mg of the compound is administered per day.

22. The method of claim 18, wherein the compound is administered twice daily in equally divided doses.

23. The method of claim 18, wherein the stereomerically pure compound comprises greater than about 90% by weight of (+) isomer based on the total weight percent of the compound.

24. The method of claim 18, wherein the stereomerically pure compound comprises greater than about 95% by weight of (+) isomer based on the total weight percent of the compound.

25. The method of claim 18, wherein the stereomerically pure compound comprises greater than about 97% by weight of (+) isomer based on the total weight percent of the compound.

26. The method of claim 18, wherein the compound is administered in capsule form.

27. The method of claim 26, wherein the capsule contains about 10 mg of the compound.

28. The method of claim 26, wherein the capsule contains about 20 mg of the compound.

29. The method of claim 26, wherein the capsule contains about 25 mg of the compound.

30. The method of claim 26, wherein the capsule contains about 50 mg of the compound.

31. The method of claim 18, wherein the compound is administered in tablet form.

32. The method of claim 31, wherein the tablet contains about 10 mg of the compound.

33. The method of claim 31, wherein the tablet contains about 20 mg of the compound.

34. The method of claim 31, wherein the tablet contains about 25 mg of the compound.

35. The method of claim 31, wherein the tablet contains about 50 mg of the compound.

36. A method of treating rheumatoid arthritis, which comprises orally administering to a patient having rheumatoid arthritis about 10 mg to about 100 mg of stereomerically pure (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoi- soindoline-1,3-dione comprising greater than about 97% by weight of (+) isomer wherein the compound is administered in the form of a tablet or capsule twice daily in equally divided doses.

37. A method of treating Behcet's Disease, which comprises administering to a patient having Behcet's Disease a therapeutically effective amount of stereomerically pure (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoi- soindoline-1,3-dione.

38. The method of claim 37, wherein the compound is administered orally.

39. The method of claim 38, wherein about 5 mg to about 500 mg of the compound is administered per day.

40. The method of claim 38, wherein about 10 mg to about 200 mg of the compound is administered per day.

41. The method of claim 38, wherein about 10 mg to about 100 mg of the compound is administered per day.

42. The method of claim 38, wherein the compound is administered twice daily in equally divided doses.

43. The method of claim 38, wherein the stereomerically pure compound comprises greater than about 90% by weight of (+) isomer based on the total weight percent of the compound.

44. The method of claim 38, wherein the stereomerically pure compound comprises greater than about 95% by weight of (+) isomer based on the total weight percent of the compound.

45. The method of claim 38, wherein the stereomerically pure compound comprises greater than about 97% by weight of (+) isomer based on the total weight percent of the compound.

46. The method of claim 38, wherein the compound is administered in capsule form.

47. The method of claim 46, wherein the capsule contains about 10 mg of the compound.

48. The method of claim 46, wherein the capsule contains about 20 mg of the compound.

49. The method of claim 46, wherein the capsule contains about 25 mg of the compound.

50. The method of claim 46, wherein the capsule contains about 50 mg of the compound.

51. The method of claim 38, wherein the compound is administered in tablet form.

52. The method of claim 51, wherein the tablet contains about 10 mg of the compound.

53. The method of claim 51, wherein the tablet contains about 20 mg of the compound.

54. The method of claim 51, wherein the tablet contains about 25 mg of the compound.

55. The method of claim 51, wherein the tablet contains about 50 mg of the compound.

56. A method of treating Behcet's Disease, which comprises orally administering to a patient having Behcet's Disease about 10 mg to about 100 mg of stereomerically pure (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoi- soindoline-1,3-dione comprising greater than about 97% by weight of (+) isomer wherein the compound is administered in the form of a tablet or capsule twice daily in equally divided doses.
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