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Claims for Patent: 8,778,924

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Claims for Patent: 8,778,924

Title:Modified release amoxicillin products
Abstract: An amoxicillin product comprising: at least one modified release component(s), wherein the at least one modified release component(s) comprises at least amoxicillin and a pharmaceutically acceptable carrier; and wherein when administered to a patient or subject in the fed state said amoxicillin product exhibits a pharmacokinetic profile for amoxicillin in the plasma characterized as follows: (1) the ratio of the portion of the AUC as measured from 2 hours post-administration to 5 hours post-administration to the portion of the AUC as measured from administration to 2 hours post-administration is at least 2.0:1; and (2) the ratio of the portion of the AUC as measured from 5 hours post-administration to 12 hours post-administration to the portion of the AUC as measured from administration to 2 hours post-administration is at least 1.1:1.
Inventor(s): Flanner; Henry H. (Montgomery Village, MD), Tolle-Sander; Sanna (North Potomac, MD), Treacy; Donald (Woodbine, MD), Burnside; Beth A. (Bethesda, MD), Clausen; Susan P. (Ijamsville, MD)
Assignee: Shionogi Inc. (Florham Park, NJ)
Application Number:11/633,315
Patent Claims: 1. A once-a-day amoxicillin product comprising: an immediate release component that includes amoxicillin and at least one modified release component, wherein the at least one modified release component comprises a first delayed release component that comprises amoxicillin coated with methacrylic acid copolymer dispersion and that initiates release of amoxicillin after the immediate release component, and a second delayed release component that comprises amoxicillin coated with a methacrylic acid copolymer dispersion and hypromellose acetate succinate and that initiates release of amoxicillin after the first delayed release component; said product when administered as a single dose in the fed state having: (a) a ratio of AUC.sub.(2-5) to AUC.sub.(0-2) of at least 2.0:1 and (b) a ratio of AUC.sub.(5-12) to AUC.sub.(0-2) of at least 1.1:1, and wherein AUC.sub.(2-5) to AUC.sub.(0-2) ratio is no greater than 10:1 and the AUC.sub.(5-12) to AUC.sub.(0-2) ratio is no greater than 10:1 and wherein the product is a once-a-day product.

2. The amoxicillin product of claim 1, wherein said product when administered as a single dose either in the fed state or the fasted state has an AUC.sub.0-inf of at least 75% of the AUC.sub.0-inf of an immediate release amoxicillin product, wherein the AUC.sub.0-inf of said immediate release amoxicillin product is determined in either the fed state or the fasted state.

3. The product of claim 1, wherein the product contains about from about 200 mg to about 2500 mg of amoxicillin.

4. The product of claim 1, wherein the product contains about 775 mg of amoxicillin.

5. The amoxicillin product of claim 1, wherein said product when administered as a single dose in the fed state has: (1) ratio of AUC(2-5) to AUC(0-2) of at least 2.2:1 and (b) a ratio of AUC(5-12) to AUC(0-2) of at least 1.2:1.

6. The product of claim 5 wherein the AUC.sub.(2-5) to AUC.sub.(0-2) ratio is no greater than 10:1 and the AUC.sub.(5-12) to AUC.sub.(0-2) ratio is no greater than 10:1.

7. The product of claim 5 wherein the product contains about from about 200 mg to about 2500 mg of amoxicillin.

8. The product of claim 5 wherein the product contains about 775 mg of amoxicillin.

9. The amoxicillin product of claim 1, wherein said product when administered as a single dose in the fed state having: (a) a ratio of AUC.sub.(2-5) to AUC.sub.(0-2) ratio of at least 1.2:1 and (b) a ratio of AUC.sub.(5-12) to AUC.sub.(0-2) of at least 2.4:1.

10. The amoxicillin product of claim 2, wherein said product when administered as a single dose in the fed state has: (a) a ratio of AUC.sub.(2-5) to AUC.sub.(0-2) ratio of at least 2.4:1 and (b) a ratio of AUC.sub.(5-12) to AUC.sub.(0-2) of at least 1.3:1.

11. The amoxicillin product of claim 1, said amoxicillin product when administered as a single dose having: (a) a ratio of AUC.sub.(2-5) to AUC.sub.(0-2) ratio of at least 2.4:1 and (b) a ratio of AUC.sub.(5-12) to AUC.sub.(0-2) of at least 1.3:1.

12. The product of claim 11 wherein the product contains about from about 200 mg to about 2500 mg of amoxicillin.

13. The product of claim 11 wherein the product contains about 775 mg of amoxicillin.

14. A process for treating a bacterial infection in a patient or a subject comprising: administering to a patient or a subject the product of claim 1.

15. A process for treating a bacterial infection in a patient or a subject comprising: administering to a patient or a subject the product of claim 2.

16. A process for treating a bacterial infection in a patient or a subject comprising: administering to a patient or a subject the product of claim 3.

17. A process for treating a bacterial infection in a patient or a subject comprising: administering to a patient or a subject the product of claim 4.

18. A process for treating a bacterial infection in a patient or a subject comprising: administering to a patient or a subject the product of claim 5.

19. A process for treating a bacterial infection in a patient or a subject comprising: administering to a patient or a subject the product of claim 6.

20. A process for treating a bacterial infection in a patient or a subject comprising: administering to a patient or a subject the product of claim 7.

21. A process for treating a bacterial infection in a patient or a subject comprising: administering to a patient or a subject the product of claim 8.

22. A process for treating a bacterial infection in a patient or a subject comprising: administering to a patient or a subject the product of claim 9.

23. A process for treating a bacterial infection in a patient or a subject comprising: administering to a patient or a subject the product of claim 10.

24. A process for treating a bacterial infection in a patient or a subject comprising: administering to a patient or a subject the product of claim 11.

25. A process for treating a bacterial infection in a patient or a subject comprising: administering to a patient or a subject the product of claim 12.

26. A process for treating a bacterial infection in a patient or a subject comprising: administering to a patient or a subject the product of claim 13.

27. The product of claim 1, wherein the product having an equivalent extent of absorption when administered in both the fasted and fed states.

28. A process for treating a bacterial infection in a patient or a subject comprising: administering to a patient or a subject the product of claim 27.

29. The product of claim 1, further comprising clavulanate or other beta-lactamase inhibitor.

30. The product of claim 2, further comprising clavulanate or other beta-lactamase inhibitor.

31. The product of claim 5, further comprising clavulanate or other beta-lactamase inhibitor.

32. The product of claim 9, further comprising clavulanate or other beta-lactamase inhibitor.

33. The product of claim 10, further comprising clavulanate or other beta-lactamase inhibitor.

34. The product of claim 11, further comprising clavulanate or other beta-lactamase inhibitor.

35. The product of claim 27, further comprising clavulanate or other beta-lactamase inhibitor.

36. A process for treating a bacterial infection in a patient or a subject comprising: administering to a patient or a subject the product of claim 29.

37. A process for treating a bacterial infection in a patient or a subject comprising: administering to a patient or a subject the product of claim 30.

38. A process for treating a bacterial infection in a patient or a subject comprising: administering to a patient or a subject the product of claim 31.

39. A process for treating a bacterial infection in a patient or a subject comprising: administering to a patient or a subject the product of claim 32.

40. A process for treating a bacterial infection in a patient or a subject comprising: administering to a patient or a subject the product of claim 33.

41. A process for treating a bacterial infection in a patient or a subject comprising: administering to a patient or a subject the product of claim 34.

42. A process for treating a bacterial infection in a patient or a subject comprising: administering to a patient or a subject the product of claim 35.

43. The product of claim 1, wherein the immediate release component about 45% of the total amoxicillin dose in the product, the first delayed release component comprises about 30% of the total amoxicillin dose in the product, and the second delayed release component comprises about 25% of the total amoxicillin dose in the product.

44. The product of claim 1, wherein the immediate release component further comprises povidone.

45. The product of claim 1, wherein the first delayed release component further comprises microcrystalline cellulose, povidone, castor oil, talc, and triethyl citrate.

46. The product of claim 1, wherein the second delayed release component further comprises microcrystalline cellulose, povidone, castor oil, talc, triethyl citrate, and sodium lauryl sulfate.

47. The product of claim 43, wherein the immediate release component further comprises povidone.

48. The product of claim 43, wherein the first delayed release component further comprises microcrystalline cellulose, povidone, castor oil, talc, and triethyl citrate.

49. The product of claim 48, wherein the second delayed release component further comprises microcrystalline cellulose, povidone, castor oil, talc, triethyl citrate, and sodium lauryl sulfate.

50. The product of claim 43 wherein the product contains about from about 200 mg to about 2500 mg of amoxicillin.

51. The product of claim 43 wherein the product contains 775 mg of amoxicillin.

52. A process for treating a bacterial infection in a patient or a subject comprising: administering to a patient or a subject the product of claim 43.

53. A process for treating a bacterial infection in a patient or a subject comprising: administering to a patient or a subject the product of claim 44.

54. A process for treating a bacterial infection in a patient or a subject comprising: administering to a patient or a subject the product of claim 45.

55. A process for treating a bacterial infection in a patient or a subject comprising: administering to a patient or a subject the product of claim 46.

56. A process for treating a bacterial infection in a patient or a subject comprising: administering to a patient or a subject the product of claim 47.

57. A process for treating a bacterial infection in a patient or a subject comprising: administering to a patient or a subject the product of claim 48.

58. A process for treating a bacterial infection in a patient or a subject comprising: administering to a patient or a subject the product of claim 49.

59. A process for treating a bacterial infection in a patient or a subject comprising: administering to a patient or a subject the product of claim 50.

60. A process for treating a bacterial infection in a patient or a subject comprising: administering to a patient or a subject the product of claim 51.
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