Details for Patent: 7,105,174
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Title: | Multiple-delayed release anti-neoplastic product, use and formulation thereof |
Abstract: | An anti-neoplastic 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 anti-neoplastic product being reached in less than about twelve hours after initial release of anti-neoplastic 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: | 10/211,035 |
Claims: | 1. A once-a-day anti-neoplastic product comprising: first, second, and third anti-neoplastic dosage forms, each of said anti-neoplastic dosage forms comprising at least one anti-neoplastic and a pharmaceutically acceptable carrier, said first, second, and third anti-neoplastic dosage forms being delayed release dosage forms, and wherein each of said first, second, and third anti-neoplastic dosage forms initiates release of said at least one anti-neoplastic at different times, said once-a-day anti-neoplastic product further comprising a therapeutically effective amount of said at least one anti-neoplastic, said therapeutically effective amount being the total dosage of said at least one anti-neoplastic for a twenty-four hour period, and wherein said at least one anti-neoplastic released by said once-a-day anti-neoplastic product achieves Cmax in serum in less than twelve hours after the initial release of anti-neoplastic, 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-neoplastic. 3. The product of claim 1, wherein the anti-neoplastic 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-neoplastic. 4. The product of claim 1, wherein the anti-neoplastic released from the second dosage form reaches a Cmax in serum in no more than about 4 hours after initial release of anti-neoplastic. 5. The product of claim 1, wherein the anti-neoplastic released from the third dosage form reaches a Cmax in serum within 8 hours after initial release of anti-neoplastic. 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-neoplastic. 7. The product of claim 1, wherein the product is an oral dosage form. 8. The product of claim 7, wherein the anti-neoplastic released from the second dosage form reaches a Cmax in the serum after Cmax is reached in the serum for the anti-neoplastic released from the first dosage form. 9. The product of claim 8, wherein the anti-neoplastic released from the third dosage form reaches a Cmax in the serum after Cmax is reached in the serum for the anti-neoplastic released from the second dosage form. 10. The product of claim 9, wherein said second dosage form initiates release of said anti-neoplastic before said third dosage form, wherein said second dosage form provides from 30% to 60% by weight of the total anti-neoplastic released by said second and third dosage forms, and wherein said third dosage form provides the remainder of the total anti-neoplastic released by said second and third dosage forms. 11. The product of claim 1 further comprising a fourth anti-neoplastic dosage form, said fourth anti-neoplastic dosage form comprising at least one anti-neoplastic and a pharmaceutically acceptable carrier and wherein said at least one anti-neoplastic released from said fourth anti-neoplastic dosage form reaches a Cmax in the serum after Cmax is achieved in the serum for anti-neoplastic released from each of said first, second, and third dosage forms. 12. The product of claim 11, wherein said fourth anti-neoplastic dosage form is a delayed release dosage form. 13. The product of claim 12, wherein said second dosage form initiates release of said anti-neoplastic before said third dosage form, wherein said third dosage form initiates release of said anti-neoplastic before said fourth dosage form, wherein said second dosage form provides 20% to 35% by weight of the total anti-neoplastic 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-neoplastic released by said second, third, and fourth dosage forms, and wherein said fourth dosage form provides the remainder of the total anti-neoplastic released by said second, third, and fourth dosage forms. 14. The product of claim 11, wherein the anti-neoplastic 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-neoplastic. 15. The product of claim 11, wherein the anti-neoplastic released from the second dosage form reaches a Cmax in serum in no more than about 4 hours after initial release of anti-neoplastic. 16. The product of claim 11, wherein the anti-neoplastic released from the third dosage form reaches a Cmax in serum within 8 hours after initial release of anti-neoplastic. 17. A process for treating a cancer in a host comprising: administering to a host the anti-neoplastic product of claim 1 once-a-day. 18. A process for treating a cancer in a host comprising: administering to a host the anti-neoplastic product of claim 2 once-a-day. 19. A process for treating a cancer in a host comprising: administering to a host the anti-neoplastic product of claim 3 once-a-day. 20. A process for treating a cancer in a host comprising: administering to a host the anti-neoplastic product of claim 4 once-a-day. 21. A process for treating a cancer in a host comprising: administering to a host the anti-neoplastic product of claim 5 once-a-day. 22. A process for treating a cancer in a host comprising: administering to a host the anti-neoplastic product of claim 6 once-a-day. 23. A process for treating a cancer in a host comprising: administering to a host the anti-neoplastic product of claim 7 once-a-day. 24. A process for treating a cancer in a host comprising: administering to a host the anti-neoplastic product of claim 8 once-a-day. 25. A process for treating a cancer in a host comprising: administering to a host the anti-neoplastic product of claim 9 once-a-day. 26. A process for treating a cancer in a host comprising: administering to a host the anti-neoplastic product of claim 10 once-a-day. 27. A process for treating a cancer in a host comprising: administering to a host the anti-neoplastic product of claim 11 once-a-day. 28. A process for treating a cancer in a host comprising: administering to a host the anti-neoplastic product of claim 12 once-a-day. 29. A process for treating a cancer in a host comprising: administering to a host the anti-neoplastic product of claim 13 once-a-day. 30. A process for treating a cancer in a host comprising: administering to a host the anti-neoplastic product of claim 14 once-a-day. 31. A process for treating a cancer in a host comprising: administering to a host the anti-neoplastic product of claim 15 once-a-day. 32. A process for treating a cancer in a host comprising: administering to a host the anti-neoplastic product of claim 16 once-a-day. 33. The once-a-day antineoplastic product of claim 1, wherein said at least one antineoplastic agent is in the form of a salt. 34. The once-a-day antineoplastic product of claim 11, wherein said at least one antineoplastic agent is in the form of a salt. 35. A process for treating a cancer in a host comprising: administering to a host the anti-neoplastic product of claim 33 once-a-day. 36. A process for treating a cancer in a host comprising: administering to a host the anti-neoplastic product of claim 34 once-a-day. 37. 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 delayed releases of antineoplastic from each of said first, second, and third dosage forms, said three delayed releases initiating release of antineoplastic at different times to produce a Cmax in serum of the total antineoplastic agent released from said antineoplastic product in less than about 12 hours from the initial release of antineoplastic agent; and said treating delivers the total dosage of said at least one antineoplastic agent for a twenty-four hour period. |