Multiple-delayed release anti-neoplastic product, use and formulation thereof
View Patent ↗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 max for the anti-neoplastic product being reached in less than about twelve hours after initial release of anti-neoplastic from the product.
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.