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Last Updated: March 29, 2024

Details for Patent: 7,157,095


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Title:Multiple-delayed release antifungal product, use and formulation thereof
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.sub.max for the anti-fungal product being reached in less than about twelve hours after initial release of anti-fungal from the product.
Inventor(s): Rudnic; Edward M. (N. Potomac, MD), Isbister; James D. (Potomac, MD), Treacy, Jr.; Donald J. (Annapolis, MD), Wassink; Sandra E. (Frederick, MD)
Assignee: Advancis Pharmaceutical Corporation (Germantown, MD)
Filing Date:Aug 02, 2002
Application Number:10/211,682
Claims: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.

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