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Details for Patent: 6,663,890

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Details for Patent: 6,663,890

Title: Metronidazole antibiotic product, use and formulation thereof
Abstract:An antibiotic product, in particular metronidazole, is comprised of at least three dosages forms, each of which has a different release profile, with the C.sub.max for the antibiotic 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. (Germantown, MD)
Filing Date:Dec 20, 2001
Application Number:10/027,866
Claims:1. A once-a-day antibiotic product comprising: first, second, and third dosage forms; each of said dosage forms comprising metronidazole and a pharmaceutically acceptable carrier; said first dosage form being an immediate release dosage form; said second and third dosage forms being delayed release dosage forms; wherein each of said first, second, and third dosage forms initiates release of metronidazole at different times; wherein Cmax of the total metronidazole released from said product is achieved in less than about 12 hours from administration; and wherein said once-a-day product contains the total dosage of metronidazole 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 metronidazole 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 metronidazole released from the second dosage form reaches a C.sub.max in no more than about 4 hours after administration of the product.

5. The product of claim 1, wherein the metronidazole 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 least 20% and no more than 50% of the total dosage of metronidazole.

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

8. The product of claim 1, wherein the metronidazole released from the second dosage form reaches a Cmax after Cmax is reached for the metronidazole released from the first dosage form.

9. The product of claim 1, wherein the metronidazole released from the third dosage form reaches a Cmax after Cmax is reached for the metronidazole released from the second dosage form.

10. The product of claim 1 further comprising a fourth dosage form, said fourth dosage form being a delayed release dosage form comprising metronidazole and a pharmaceutically acceptable carrier; and wherein metronidazole released from said fourth dosage form reaches a Cmax after Cmax is achieved for metronidazole released from each of said first, second, and third dosage forms.

11. The product of claim 10, wherein the Cmax for the product is reached no earlier than four hours after administration.

12. The product of claim 10, wherein the metronidazole released from the first dosage form reaches a Cmax within from about 0.5 hours to about 2 hours after administration of the product.

13. The product of claim 10 wherein the metronidazole released from the second dosage form reaches a Cmax in no more than about 4 hours after administration of the product.

14. The product of claim 10, wherein the metronidazole released from the third dosage form reaches a Cmax within 8 hours after administration of the product.

15. The product of claim 10, wherein said second dosage form initiates release of metronidazole before said third dosage form, wherein said third dosage form initiates release of metronidazole before said fourth dosage form, wherein said second dosage form provides 20% to 35% by weight of the total metronidazole released by said second, third, and fourth dosage forms, wherein said third dosage form provides from 20% to 40% by weight of the total metronidazole released by said second, third, and fourth dosage forms, and wherein said fourth dosage form provides the remainder of the total metronidazole released by said second, third, and fourth dosage forms.

16. The product of claim 10, wherein the product is an oral dosage form.

17. The product of claim 10, wherein the metronidazole released from the second dosage form reaches a Cmax after Cmax is reached for the metronidazole released from the first dosage form.

18. The product of claim 10 wherein the metronidazole released from the third dosage form reaches a Cmax after Cmax is reached for the metronidazole released from the second dosage form.

19. A process for treating a bacterial infection in a host comprising: administering to a host the metronidazole product of claim 1, once-a-day.

20. A process for treating a bacterial infection in a host comprising: administering to a host the metronidazole product of claim 2 once-a-day.

21. A process for treating a bacterial infection in a host comprising: administering to a host the metronidazole product of claim 3, once-a-day.

22. A process for treating a bacterial infection in a host comprising: administering to a host the metronidazole product of claim 4, once-a-day.

23. A process for treating a bacterial infection in a host comprising: administering to a host the metronidazole product of claim 5, once-a-day.

24. A process for treating a bacterial infection in a host comprising: administering to a host the metronidazole product of claim 6, once-a-day.

25. A process for treating a bacterial infection in a host comprising: administering to a host the metronidazole product of claim 7, once-a-day.

26. A process for treating a bacterial infection in a host comprising: administering to a host the metronidazole product of claim 8, once-a-day.

27. A process for treating a bacterial infection in a host comprising: administering to a host the metronidazole product of claim 9, once-a-day.

28. A process for treating a bacterial infection in a host comprising: administering to a host the metronidazole product of claim 10, once-a-day.

29. A process for treating a bacterial infection in a host comprising: administering to a host the metronidazole product of claim 11, once-a-day.

30. A process for treating a bacterial infection in a host comprising: administering to a host the metronidazole product of claim 12 once-a-day.

31. A process for treating a bacterial infection in a host comprising: administering to a host the metronidazole product of claim 13, once-a-day.

32. A process for treating a bacterial infection in a host comprising: administering to a host the metronidazole product of claim 14, once-a-day.

33. A process for treating a bacterial infection in a host comprising: administering to a host the metronidazole product of claim 15, once-a-day.

34. A process for treating a bacterial infection in a host comprising: administering to a host the metronidazole product of claim 16, once-a-day.

35. A process for treating a bacterial infection in a host comprising: administering to a host the metronidazole product of claim 17, once-a-day.

36. A process for treating a bacterial infection in a host comprising: administering to a host the metronidazole product of claim 18, once-a-day.

37. The once-a-day antibiotic product of claim 1, wherein the metronidazole is in the form of a salt.

38. A process for treating a bacterial infection in a host comprising: administering to a host the metronidazole product of claim 37, once-a-day.
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