IP Library Granted Patent US 7,157,095
Granted Patent B2
US 7,157,095 · App. 10/211,682 · Granted Jan 2, 2007

Multiple-delayed release antifungal product, use and formulation thereof

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Quick Facts
Patent No.
US 7,157,095
App. No.
10/211,682
Granted
Jan 2, 2007
Kind
B2
Abstract

An anti-fungal product is comprised of at least three delayed release dosages forms, each of which has a different release profile, with the C max for the anti-fungal product being reached in less than about twelve hours after initial release of anti-fungal from the product.

Claims (42)

1. A once-a-day anti-fungal product comprising: first, second, and third anti-fungal dosage forms, each of said anti-fungal dosage forms comprising at least one anti-fungal and a pharmaceutically acceptable carrier, said first, second, and third anti-fungal dosage forms being delayed release dosage forms, and wherein each of said first, second, and third anti-fungal dosage forms initiates release at different times and Cmax of the total anti-fungal released from said anti-fungal product is achieved in less than about 12 hours after initial release of anti-fungal, and said once-a-day anti-fungal product contains the total dosage of the at least one anti-fungal for a twenty-four hour period, said product being free of an immediate release dosage form.

2. The product of claim 1 , wherein the Cmax for the product is reached no earlier than four hours after initial release of anti-fungal.

3. The product of claim 1 , wherein the anti-fungal released from the first dosage form reaches a Cmax in serum within from about 0.5 hours to about 2 hours after initial release of anti-fungal.

4. The product of claim 1 , wherein the anti-fungal released from the second dosage form reaches a Cmax in serum in no more than about 4 hours after initial release of anti-fungal.

5. The product of claim 1 , wherein the anti-fungal released from the third dosage form reaches a Cmax in serum within 8 hours after initial release of anti-fungal.

6. The product of claim 1 , wherein the first release dosage form contains at least 20% and no more than 50% of the total dosage of anti-fungal.

7. The product of claim 1 , wherein the product is an oral dosage form.

8. The product of claim 7 , wherein the anti-fungal released from the second dosage form reaches a Cmax in the serum after Cmax is reached in the serum for the anti-fungal released from the first dosage form.

9. The product of claim 8 , wherein the anti-fungal released from the third dosage form reaches a Cmax in the serum after Cmax is reached in the serum for the anti-fungal released from the second dosage form.

10. The product of claim 9 , wherein said second dosage form initiates release of said anti-fungal before said third dosage form, wherein said second dosage form provides from 30% to 60% by weight of the total anti-fungal released by said second and third dosage forms, and wherein said third dosage form provides the remainder of the total anti-fungal released by said second and third dosage forms.

11. The product of claim 1 further comprising a fourth anti-fungal dosage form, said fourth anti-fungal dosage form comprising at least one anti-fungal and a pharmaceutically acceptable carrier and wherein said at least one anti-fungal released from said fourth anti-fungal dosage form reaches a Cmax in the serum after Cmax is achieved in the serum for anti-fungal released from each of said first, second, and third dosage forms.

12. The product of claim 11 , wherein said fourth anti-fungal dosage form is a delayed release dosage form.

13. The product of claim 12 , wherein said second dosage form initiates release of said anti-fungal before said third dosage form, wherein said third dosage form initiates release of said anti-fungal before said fourth dosage form, wherein said second dosage form provides 20% to 35% by weight of the total anti-fungal released by said second, third, and fourth dosage forms, wherein said third dosage form provides from 20% to 40% by weight of the total anti-fungal released by said second, third, and fourth dosage forms, and wherein said fourth dosage form provides the remainder of the total anti-fungal released by said second, third, and fourth dosage forms.

14. The product of claim 11 , wherein the anti-fungal released from the first dosage form reaches a Cmax in serum within from about 0.5 hours to about 2 hours after initial release of anti-fungal.

15. The product of claim 11 , wherein the anti-fungal released from the second dosage form reaches a Cmax in serum in no more than about 4 hours after initial release of anti-fungal.

16. The product of claim 11 , wherein the anti-fungal released from the third dosage form reaches a Cmax in serum within 8 hours after initial release of anti-fungal.

17. The product of claim 1 , wherein each of said first, second, and third delayed release dosage forms release said at least one anti-fungal agent enterically.

18. The product of claim 17 , wherein each of said first, second, and third delayed release dosage forms are pH-sensitive delayed release dosage forms.

19. The product of claim 17 , wherein each of said first, second, and third delayed release dosage forms are non-pH-sensitive delayed release dosage forms.

20. The product of claim 17 , wherein each of said first, second, and third delayed release dosage forms are each independently selected from the group consisting of pH-sensitive delayed release dosage forms and non-pH-sensitive delayed release dosage forms.

21. A process for treating a fungal infection in a host comprising: administering to a host the anti-fungal product of claim 17 once-a-day.

22. A process for treating a fungal infection in a host comprising: administering to a host the anti-fungal product of claim 18 once-a-day.

23. A process for treating a fungal infection in a host comprising: administering to a host the anti-fungal product of claim 19 once-a-day.

24. A process for treating a fungal infection in a host comprising: administering to a host the anti-fungal product of claim 20 once-a-day.

25. A process for treating a fungal infection in a host comprising: administering to a host the anti-fungal product of claim 1 once-a-day.

26. A process for treating a fungal infection in a host comprising: administering to a host the anti-fungal product of claim 2 once-a-day.

27. A process for treating a fungal infection in a host comprising: administering to a host the anti-fungal product of claim 3 once-a-day.

28. A process for treating a fungal infection in a host comprising: administering to a host the anti-fungal product of claim 4 once-a-day.

29. A process for treating a fungal infection in a host comprising: administering to a host the anti-fungal product of claim 5 once-a-day.

30. A process for treating a fungal infection in a host comprising: administering to a host the anti-fungal product of claim 6 once-a-day.

31. A process for treating a fungal infection in a host comprising: administering to a host the anti-fungal product of claim 7 once-a-day.

32. A process for treating a fungal infection in a host comprising: administering to a host the anti-fungal product of claim 8 once-a-day.

33. A process for treating a fungal infection in a host comprising: administering to a host the anti-fungal product of claim 9 once-a-day.

34. A process for treating a fungal infection in a host comprising: administering to a host the anti-fungal product of claim 10 once-a-day.

35. A process for treating a fungal infection in a host comprising: administering to a host the anti-fungal product of claim 11 once-a-day.

36. A process for treating a fungal infection in a host comprising: administering to a host the anti-fungal product of claim 12 once-a-day.

37. A process for treating a fungal infection in a host comprising: administering to a host the anti-fungal product of claim 13 once-a-day.

38. A process for treating a fungal infection in a host comprising: administering to a host the anti-fungal product of claim 14 once-a-day.

39. A process for treating a fungal infection in a host comprising: administering to a host the anti-fungal product of claim 15 once-a-day.

40. A process for treating a fungal infection in a host comprising: administering to a host the anti-fungal product of claim 16 once-a-day.

41. A once-a-day anti-fungal product for oral administration comprising: first, second, and third anti-fungal dosage forms, each of said anti-fungal dosage forms comprising at least one anti-fungal and a pharmaceutically acceptable carrier, said first, second, and third anti-fungal dosage forms being delayed release dosage forms, and wherein each of said first, second, and third anti-fungal dosage forms initiates release at different times and Cmax of the total anti-fungal released from said anti-fungal product is achieved in less than about 12 hours after initial release of anti-fungal, and said once-a-day anti-fungal product contains the total dosage of the at least one anti-fungal for a twenty-four hour period, said product being free of an immediate release dosage form.

42. A process for treating a fungal infection in a host comprising: administering to a host the anti-fungal product of claim 41 once-a-day.

Assignments (5)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 3, 2011
From: VICTORY PHARMA, INC.
To: SHIONOGI INC.
Reel/Frame 027004/0189 →
SECURITY AGREEMENT Recorded Jul 29, 2011
From: BANK OF AMERICA, N.A.
To: VICTORY PHARMA, INC.
Reel/Frame 026676/0070 →
SECURITY INTEREST Recorded Oct 8, 2010
From: VICTORY PHARMA, INC.
To: BANK OF AMERICA, N.A.
Reel/Frame 025114/0848 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 9, 2010
From: MIDDLEBROOK PHARMACEUTICALS, INC.
To: VICTORY PHARMA, INC.
Reel/Frame 024964/0036 →
CHANGE OF NAME Recorded Nov 9, 2007
From: ADVANCIS PHARMACEUTICAL CORPORATION
To: MIDDLEBROOK PHARMACEUTICALS, INC.
Reel/Frame 020089/0910 →