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Details for Patent: 7,025,989

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Details for Patent: 7,025,989

Title:Multiple-delayed released antibiotic product, use and formulation thereof
Abstract: An antibiotic 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 antibiotic product being reached in less than about twelve hours.
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:Aug 02, 2002
Application Number:10/211,039
Claims:1. A once-a-day antibiotic product comprising: first, second, and third antibiotic dosage forms, each of said antibiotic dosage forms comprising at least one antibiotic and a pharmaceutically acceptable carrier, said first, second, and third antibiotic dosage forms being delayed release dosage forms, and wherein each of said first, second, and third antibiotic dosage forms initiates release at different times and Cmax of the total antibiotic released from said antibiotic product is achieved in less than about 12 hours after initial release of antibiotic, and said once-a-day antibiotic product contains the total dosage of the at least one antibiotic 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 antibiotic.

3. The product of claim 1, wherein the antibiotic 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 antibiotic.

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

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

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 antibiotic.

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

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

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

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

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

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

13. The product of claim 12, wherein said second dosage form initiates release of said antibiotic before said third dosage form, wherein said third dosage form initiates release of said antibiotic before said fourth dosage form, wherein said second dosage form provides 20% to 35% by weight of the total antibiotic released by said second, third, and fourth dosage forms, wherein said third dosage form provides from 20% to 40% by weight of the total antibiotic released by said second, third, and fourth dosage forms, and wherein said fourth dosage form provides the remainder of the total antibiotic released by said second, third, and fourth dosage forms.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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