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Claims for Patent: 8,889,185

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Claims for Patent: 8,889,185

Title:Modified release compositions comprising tacrolimus
Abstract: A modified release composition comprising tacrolimus which is useful for the treatment or prevention of rejection reactions by transplantation of organs or tissues.
Inventor(s): Holm; Per (Vanlose, DK), Norling; Tomas (Lyngby, DK)
Assignee: Veloxis Pharmaceuticals A/S (Horsholm, DK)
Application Number:14/079,414
Patent Claims: 1. A method of suppressing a rejection reaction by transplantation of an organ in a patient, the method comprising orally administering to the patient an oral, once daily, extended release pharmaceutical composition comprising tacrolimus wherein the in vivo release of the extended release pharmaceutical composition after oral administration takes place substantially in the lower gastrointestinal tract, and the pharmaceutical composition provides a W.sub.50 (the time where the plasma concentration is 50% or more of C.sub.max) of at least 10 hours.

2. The method of claim 1, wherein the pharmaceutical composition provides a W.sub.50 of at least 11 hours.

3. The method of claim 2, wherein the pharmaceutical composition provides a W.sub.50 of at least 12 hours.

4. The method of claim 3, wherein the pharmaceutical composition provides a W.sub.50 of at least 13 hours.

5. The method of claim 4, wherein the pharmaceutical composition provides a W.sub.50 of at least 14 hours.

6. A method of suppressing a rejection reaction by transplantation of an organ in a patient, the method comprising orally administering to the patient an oral, once daily, extended release pharmaceutical composition comprising tacrolimus wherein the in vivo release of the extended release pharmaceutical composition after oral administration takes place substantially in the lower gastrointestinal tract, and the pharmaceutical composition provides an AUC.sub.fed/AUC.sub.fasted of at least about 0.9.

7. The method of claim 6, wherein the pharmaceutical composition comprises a modifying release agent.

8. The method of claim 6, wherein the pharmaceutical composition is in the form of a compressed tablet.

9. The method of claim 6, wherein the extended release pharmaceutical composition is designed to substantially avoid CYP3A4 metabolism in the gastrointestinal tract upon oral administration.

10. The method of claim 8, wherein the extended release pharmaceutical composition provides a zero order release profile.

11. A method of suppressing a rejection reaction by transplantation of an organ in a patient, the method comprising orally administering to the patient an oral, once daily, extended release pharmaceutical composition comprising tacrolimus wherein the in vivo release of the extended release pharmaceutical composition after oral administration takes place substantially in the lower gastrointestinal tract, and the oral administration of the composition results in a plasma concentration of about 5 ng/mL to about 20 ng/mL for at least about 24 hours.

12. The method of claim 11, wherein the pharmaceutical composition comprises a solid dispersion or solid solution of tacrolimus.

13. The method of claim 11, wherein the pharmaceutical composition provides a W.sub.50 of at least 11 hours.

14. The method of claim 13, wherein the pharmaceutical composition provides a W.sub.50 of at least 12 hours.

15. The method of claim 14, wherein the pharmaceutical composition provides a W.sub.50 of at least 13 hours.

16. The method of claim 15, wherein the pharmaceutical composition provides a W.sub.50 of at least 14 hours.

17. The method of claim 1, wherein the extended release pharmaceutical composition provides a zero order release profile.

18. The method of claim 6, wherein the extended release pharmaceutical composition provides a zero order release profile.

19. The method of claim 11, wherein the extended release pharmaceutical composition provides a zero order release profile.

20. The method of claim 1, wherein the patient is a kidney transplant patient.

21. The method of claim 1, wherein the patient is a liver transplant patient.

22. The method of claim 6, wherein the patient is a kidney transplant patient.

23. The method of claim 6, wherein the patient is a liver transplant patient.

24. The method of claim 11, wherein the patient is a kidney transplant patient.

25. The method of claim 11, wherein the patient is a liver transplant patient.

26. The method of claim 18, wherein the patient is a kidney transplant patient.

27. The method of claim 18, wherein the patient is a liver transplant patient.

28. The method of claim 19, wherein the patient is a kidney transplant patient.

29. The method of claim 19, wherein the patient is a liver transplant patient.
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