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Details for Patent: 7,108,859

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Details for Patent: 7,108,859

Title:Antineoplastic product, use and formulation thereof
Abstract: An antineoplastic product is comprised of at least three dosages forms, each of which has a different release profile, with the C.sub.max for the antineoplastic 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 Corporation (Germantown, MD)
Filing Date:Oct 21, 2002
Application Number:10/274,931
Claims:1. A once-a-day antineoplastic product comprising: first, second, and third dosage forms, wherein each of said dosage forms includes at least one antineoplastic agent and a pharmaceutically acceptable carrier; said first dosage form is an immediate release dosage form; said second and third dosage forms are delayed release dosage forms; each of said first, second, and third dosage forms initiates release of said at least one antineoplastic agent at different times; Cmax in serum of the total antineoplastic agent released from said antineoplastic product is achieved in less than about 12 hours from administration; and said once-a-day antineoplastic product contains the total dosage of said at least one antineoplastic agent 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 antineoplastic 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 antineoplastic 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 antineoplastic 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 antineoplastic.

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

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

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

10. The product of claim 1 further comprising a fourth antineoplastic dosage form, said fourth antineoplastic dosage form being a delayed release dosage form and comprising at least one antineoplastic and a pharmaceutically acceptable carrier and wherein said at least one antineoplastic released from said fourth antineoplastic dosage form reaches a Cmax after Cmax is achieved for antineoplastic 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 antineoplastic 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 antineoplastic 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 antineoplastic 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 said antineoplastic before said third dosage form, wherein said third dosage form initiates release of said antineoplastic before said fourth dosage form, wherein said second dosage form provides 20% to 35% by weight of the total antineoplastic released by said second, third, and fourth dosage forms, wherein said third dosage form provides from 20% to 40% by weight of the total antineoplastic released by said second, third, and fourth dosage forms, and wherein said fourth dosage form provides the remainder of the total antineoplastic 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 antineoplastic released from the second dosage form reaches a Cmax after Cmax is reached for the antineoplastic released from the first dosage form.

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

19. The once-a-day antineoplastic product of claim 1, wherein said at least one antineoplastic agent is in the form of a salt.

20. The once-a-day antineoplastic product of claim 10, wherein said at least one antineoplastic agent is in the form of a salt.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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