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Claims for Patent: 8,415,396

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Claims for Patent: 8,415,396

Title:Colchine compositions and methods
Abstract: Stable ultrapure colchicine compositions comprising ultrapure colchicine and a pharmaceutically acceptable excipient are described. The compositions can be tablets. Methods for preparing such compositions and methods of use are also disclosed. Methods of treating gout flares with colchicine compositions are also disclosed.
Inventor(s): Davis; Matthew W. (Erwinna, PA), Feng; Hengsheng (Cherry Hill, NJ)
Assignee: Takeda Pharmaceuticals U.S.A., Inc. (Deerfield, IL)
Application Number:13/452,277
Patent Claims: 1. A method of treating a patient having a gout flare, the method consisting of: orally administering 1.2 mg colchicine to a human patient at onset of a gout flare; and then orally administering 0.6 mg colchicine to the patient about one hour after administering the 1.2 mg colchicine, the method providing an apparent total body clearance (C L/F) in a range of 2.4 L/hr to 5.3 L/hr.

2. The method of claim 1, wherein each said orally administering comprises administering one or more dosage forms each containing 0.6 mg colchicine.

3. The method of claim 2, wherein the dosage form is a tablet.

4. The method of claim 3 wherein the tablet is an immediate release tablet.

5. The method of claim 1, wherein the colchicine is administered with or without food.

6. A method of treating a patient having a gout flare, the method consisting of: orally administering 1.2 mg colchicine to a human patient at onset of a gout flare; and then orally administering 0.6 mg colchicine to the patient about one hour after administering the 1.2 mg colchicine, the method providing an apparent total volume of distribution (V.sub.area/F) in a range of 0.77 L/hr to 1.7 L/hr.

7. The method of claim 6, wherein each said orally administering comprises administering one or more dosage forms each containing 0.6 mg colchicine.

8. The method of claim 7, wherein the dosage form is a tablet.

9. The method of claim 8, wherein the tablet is an immediate release tablet.

10. The method of claim 6, wherein the colchicine is administered with or without food.

11. A method of treating a patient having a gout flare, the method consisting of: orally administering 1.2 mg colchicine to a human patient at onset of a gout flare; and then orally administering 0.6 mg colchicine to the patient about one hour after the first administration, the method providing a maximum colchicine blood plasma concentration (C.sub.max) in a range of 3.2 to 11.4 ng/mL, and a time after the first administration at which C.sub.max is reached (T.sub.max) of 1.0 to 2.5 hr.

12. The method of claim 11, the method further providing an area under the curve of colchicine plasma concentration versus time from time 0 to time t (AUC.sub.0-t), where t is the last time point with a measurable colchicine plasma concentration, in a range of 28.8 to 58.9 ng-hr/mL.

13. The method of claim 11, the method further providing an area under the curve of colchicine plasma concentration versus time from time 0 to time infinity (AUC.sub.0-.infin.) in a range of 34.2 to 74.1 ng-hr/mL.

14. The method of claim 11, the method further providing an area under the curve of colchicine plasma concentration versus time from time 0 to time t (AUC.sub.0-t), where t is the last time point with a measurable colchicine plasma concentration, in a range of 28.8 to 58.9 ng-hr/mL and an area under the curve of colchicine plasma concentration versus time from time 0 to time infinity (AUC.sub.0-.infin.) in a range of 34.2 to 74.1 ng-hr/mL.

15. The method of claim 11, wherein each said orally administering comprises administering one or more dosage forms each containing 0.6 mg colchicine.

16. The method of claim 15, wherein the dosage form is a tablet.

17. The method of claim 16, wherein the tablet is an immediate release tablet.

18. The method of claim 11, wherein the colchicine is administered with or without food.

19. A method of treating a patient having a gout flare, the method consisting of: orally administering 1.2 mg colchicine to a human patient at onset of a gout flare; and then orally administering 0.6 mg colchicine to the patient about one hour after the first administration, the method providing a mean maximum colchicine blood plasma concentration (C.sub.max) in a range of 3.8 to 8.6 ng/mL and a mean time after the first administration at which C.sub.max is reached (T.sub.max) in a range of 1.4 to 2.2 hr.

20. The method of claim 19, the method further providing a mean area under the curve of colchicine plasma concentration versus time from time 0 to time t (AUC.sub.0-t), where t is the last time point with a measurable colchicine plasma concentration, in a range of 32.4 to 55.2 ng-hr/mL.

21. The method of claim 19, the method further providing a mean area under the curve of colchicine plasma concentration versus time from time 0 to time infinity (AUC.sub.0-.infin.) in a range of 38.4 to 65.8 ng-hr/mL.

22. The method of claim 19, the method further providing a mean area under the curve of colchicine plasma concentration versus time from time 0 to time t (AUC.sub.0-t), where t is the last time point with a measurable colchicine plasma concentration, in a range of 32.4 to 55.2 ng-hr/mL and a mean area under the curve of colchicine plasma concentration versus time from time 0 to time infinity (AUC.sub.0-.infin.) in a range of 38.4 to 65.8 ng-hr/mL.

23. The method of claim 19, wherein each said orally administering comprises administering one or more dosage forms each containing 0.6 mg colchicine.

24. The method of claim 23, wherein the dosage form is a tablet.

25. The method of claim 24, wherein the tablet is an immediate release tablet.

26. The method of claim 19, wherein the colchicine is administered with or without food.
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