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Details for Patent: 6,541,014

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Details for Patent: 6,541,014

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. (Arnold, MD), Wassink; Sandra E. (Frederick, MD)
Assignee: Advancis Pharmaceutical Corp. (Gaithersburg, MD)
Filing Date:Feb 22, 2001
Application Number:09/791,906
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, and wherein each of said first, second, and third antiviral dosage forms initiates release of said at least one antiviral at different times, said once-a-day antiviral product further comprising a therapeutically effective amount of said at least one antiviral, said therapeutically effective amount being the total dosage of said at least one antiviral for a twenty-four hour period, and wherein said at least one antiviral released by said once-a-day antiviral product achieves Cmax in serum in less than twelve hours after administration.

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 in serum 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 serum 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 in serum 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 in the serum after Cmax is reached in the serum 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 in the serum after Cmax is reached in the serum for the antiviral released from the second dosage form.

10. The product of claim 9, 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 pharmaceutically 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 12, wherein said second dosage form initiates release of said antiviral before said third dosage form, wherein said third dosage form initiates release of said 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.

14. The product of claim 11, wherein the antiviral released from the first dosage form reaches a Cmax in serum 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 serum 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 in serum within 8 hours after administration of the product.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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