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Details for Patent: 7,074,417

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Details for Patent: 7,074,417

Title:Multiple-delayed release anti-viral product, use and formulation thereof
Abstract: An anti-viral product is comprised of at least three delayed release dosage forms, each of which has a different release profile, with the C.sub.max for the anti-viral product being reached in less than about twelve hours after initial release of anti-viral 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:10/211,729
Claims:1. A once-a-day anti-viral product comprising: first, second, and third anti-viral dosage forms, each of said anti-viral dosage forms comprising at least one anti-viral and a pharmaceutically acceptable carrier, said first, second, and third anti-viral dosage forms being delayed release dosage forms, and wherein each of said first, second, and third anti-viral dosage forms initiates release at different times and Cmax in serum of the total anti-viral released from said anti-viral product is achieved in less than about 12 hours after initial release of anti-viral, and said once-a-day antiviral product contains the total dosage of the at least one anti-viral 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-viral.

3. The product of claim 1, wherein the anti-viral 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-viral.

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

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

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-viral.

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

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

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

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

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

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

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

14. The product of claim 11, wherein the anti-viral 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-viral.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

33. A process for treating a patient with an anti-viral agent said process for treating comprising: administering to a patient once-a-day an anti-viral product, said product comprising: first, second, and third dosage forms, wherein each of said dosage forms includes at least one anti-viral agent and a pharmaceutically acceptable carrier; said treating including delayed releases of anti-viral agent from each of said first, second, and third dosage forms, said three delayed releases initiating release of anti-viral agent at different times to produce a Cmax in serum of the total anti-viral agent released from said anti-viral product in less than about 12 hours from the initial release of anti-viral agent; and said treating delivers the total dosage of said at least one anti-viral agent for a twenty-four hour period.
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