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Details for Patent: 6,984,401

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Details for Patent: 6,984,401

Title:Antiviral product, use and formulation thereof
Abstract: An antiviral product is comprised of at least three dosages forms, each of which has a different release profile, with the C.sub.max for the antiviral product being reached in less than about twelve hours. In one embodiment, there is an immediate release dosage form, as well as two or more delayed release dosage forms, with each of the dosage forms having a different release profile, wherein each reaches a C.sub.max at different times.
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 Corp. (Germantown, MD)
Filing Date:Nov 05, 2002
Application Number:10/288,000
Claims:1. A once-a-day antiviral product comprising: first, second, and third antiviral dosage forms, each of said antiviral dosage forms comprising at least one antiviral and a pharmaceutically acceptable carrier, said first antiviral dosage form being an immediate release dosage form, said second and third antiviral dosage forms being delayed release dosage forms wherein at least one of said second or third dosage forms is a pH sensitive dosage form, and wherein each of said first, second, and third antiviral dosage forms initiates release at different times and Cmax in serum of the total antiviral released from said antiviral product is achieved in less than about 12 hours from administration and said once-a-day antiviral product contains the total dosage of the at least one antiviral for a twenty-four hour period.

2. The product of claim 1, wherein the Cmax for the product is reached no earlier than four hours after administration.

3. The product of claim 1, wherein the antiviral released from the first dosage form reaches a Cmax within from about 0.5 hours to about 2 hours after administration of the product.

4. The product of claim 1, wherein the antiviral released from the second dosage form reaches a Cmax in no more than about 4 hours after administration of the product.

5. The product of claim 1, wherein the antiviral released from the third dosage form reaches a Cmax within 8 hours after administration of the product.

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

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

8. The product of claim 7, wherein the antiviral released from the second dosage form reaches a Cmax after Cmax is reached for the antiviral released from the first dosage form.

9. The product of claim 8, wherein the antiviral released from the third dosage form reaches a Cmax after Cmax is reached for the antiviral released from the second dosage form.

10. The product of claim 1, wherein said second dosage form initiates release of said antiviral before said third dosage form, wherein said second dosage form provides from 30% to 60% by weight of the total antiviral released by said second and third dosage forms, and wherein said third dosage form provides the remainder of the total antiviral released by said second and third dosage forms.

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

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

13. The product of claim 11, wherein the Cmax for the product is reached no earlier than four hours after administration.

14. The product of claim 11, wherein the antiviral released from the first dosage form reaches a Cmax within from about 0.5 hours to about 2 hours after administration of the product.

15. The product of claim 11, wherein the antiviral released from the second dosage form reaches a Cmax in no more than about 4 hours after administration of the product.

16. The product of claim 11, wherein the antiviral released from the third dosage form reaches a Cmax within 8 hours after administration of the product.

17. The product of claim 11, wherein said second dosage form initiates release of antiviral before said third dosage form, wherein said third dosage form initiates release of antiviral before said fourth dosage form, wherein said second dosage form provides 20% to 35% by weight of the total antiviral released by said second, third, and fourth dosage forms, wherein said third dosage form provides from 20% to 40% by weight of the total antiviral released by said second, third, and fourth dosage forms, and wherein said fourth dosage form provides the remainder of the total antiviral released by said second, third, and fourth dosage forms.

18. The product of claim 11, wherein the product is an oral dosage form.

19. The product of claim 11, wherein the antiviral released from the second dosage form reaches a Cmax after Cmax is reached for the antiviral released from the first dosage form.

20. The product of claim 11, wherein the antiviral released from the third dosage form reaches a Cmax after Cmax is reached for the antiviral released from the second dosage form.

21. A process for treating a viral infection in a host comprising: administering to a host the antiviral product of claim 1, once-a-day.

22. A process for treating a viral infection in a host comprising: administering to a host the antiviral product of claim 2, once-a-day.

23. A process for treating a viral infection in a host comprising: administering to a host the antiviral product of claim 3, once-a-day.

24. A process for treating a viral infection in a host comprising: administering to a host the antiviral product of claim 4, once-a-day.

25. A process for treating a viral infection in a host comprising: administering to a host the antiviral product of claim 5, once-a-day.

26. A process for treating a viral infection in a host comprising: administering to a host the antiviral product of claim 6, once-a-day.

27. A process for treating a viral infection in a host comprising: administering to a host the antiviral product of claim 7, once-a-day.

28. A process for treating a viral infection in a host comprising: administering to a host the antiviral product of claim 8, once-a-day.

29. A process for treating a viral infection in a host comprising: administering to a host the antiviral product of claim 9, once-a-day.

30. A process for treating a viral infection in a host comprising: administering to a host the antiviral product of claim 10, once-a-day.

31. A process for treating a viral infection in a host comprising: administering to a host the antiviral product of claim 11, once-a-day.

32. A process for treating a viral infection in a host comprising: administering to a host the antiviral product of claim 12, once-a-day.

33. A process for treating a viral infection in a host comprising: administering to a host the antiviral product of claim 13, once-a-day.

34. A process for treating a viral infection in a host comprising: administering to a host the antiviral product of claim 14, once-a-day.

35. A process for treating a viral infection in a host comprising: administering to a host the antiviral product of claim 15, once-a-day.

36. A process for treating a viral infection in a host comprising: administering to a host the antiviral product of claim 16, once-a-day.

37. A process for treating a viral infection in a host comprising: administering to a host the antiviral product of claim 17, once-a-day.

38. A process for treating a viral infection in a host comprising: administering to a host the antiviral product of claim 18, once-a-day.

39. A process for treating a viral infection in a host comprising: administering to a host the antiviral product of claim 19, once-a-day.

40. A process for treating a viral infection in a host comprising: administering to a host the antiviral product of claim 20, once-a-day.

41. The once-a-day antiviral product of claim 1, wherein the antiviral is in the form of a salt.

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

43. A process for treating a patient with an antiviral agent said process for treating comprising: administering to a patient once-a-day an antiviral product, said product comprising: first, second, and third dosage forms, wherein each of said dosage forms includes at least one antiviral agent and a pharmaceutically acceptable carrier; said treating including an immediate release of antiviral agent from said first dosage form and delayed releases of antiviral agent from each of said second and third dosage forms, wherein at least one of said second or third dosage forms is a pH sensitive dosage form, said immediate release and two delayed releases initiating release of antiviral agent at different times to produces a Cmax in serum of the total antiviral agent released from said antiviral product in less than about 12 hours from administration; and said treating delivers the total dosage of said at least one antiviral agent for a twenty-four hour period.
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