Formulations of 14-epi-analogues of vitamin D

1. An oral formulation wherein said formulation is a dry formulation which comprises:

at least one 14-epi-analogue of vitamin D in a concentration of between 0.001 and 50% (weight),

carboxymethylcellulose in a concentration between 0.1% and 50% (weight), and

one or more optional pharmaceutically acceptable excipient(s)

wherein said 14-epi-analogue of vitamin D is inecalcitol and wherein the formulation is characterized by an improved absorption profile over the medium chain triglycerides formulation of said 14-epi-analogue of vitamin D.

2. The oral formulation according to claim 1 in a unit dose.

3. The oral formulation according to claim 1 in the form of a tablet, a pill, powder, a hard capsule, a pastille, a troche, a lozenge.

4. The oral formulation according to claim 1 which further comprises a binder, a diluent, a disintegrant, a lubricant, a glidant, an antioxidant, a sweetening agent or a flavoring agent.

5. The oral formulation according to claim 1 , comprising from 0.5 to 20 mg of said 14-epi-analogue of vitamin D.

6. The oral formulation according to claim 1 , wherein it is characterized by a higher Cmax than the corresponding formulation in medium chain triglycerides.

7. The oral formulation according to claim 6 in a unit dose.

8. The oral formulation according to claim 6 in the form of a tablet, a pill, powder, a hard capsule, a pastille, a troche, a lozenge.

9. The oral formulation according to claim 6 , which further comprises a binder, a diluent, a disintegrant, a lubricant, a glidant, an antioxidant, a sweetening agent or a flavoring agent.

10. The oral formulation according to claim 6 , comprising from 0.5 to 20 mg of said 14-epi-analogue of vitamin D.

11. The oral formulation according to claim 1 , wherein the formulation is characterized by a higher AUC0-24 h than the corresponding formulation in medium chain triglycerides.

12. The oral formulation according to claim 11 in a unit dose.

13. The oral formulation according to claim 11 in the form of a tablet, a pill, powder, a hard capsule, a pastille, a troche, a lozenge.

14. The oral formulation according to claim 11 which further comprises a binder, a diluent, a disintegrant, a lubricant, a glidant, an antioxidant, a sweetening agent or a flavoring agent.

15. The oral formulation according to claim 11 , comprising from 0.5 to 20 mg of said 14-epi-analogue of vitamin D.

16. The oral formulation according to claim 6 , wherein the formulation is characterized by a higher AUC0-24 h than the corresponding formulation in medium chain triglycerides.

17. The oral formulation according to claim 16 in a unit dose.

18. The oral formulation according to claim 16 in the form of a tablet, a pill, powder, a hard capsule, a pastille, a troche, a lozenge.

19. The oral formulation according to claim 16 which further comprises a binder, a diluent, a disintegrant, a lubricant, a glidant, an antioxidant, a sweetening agent or a flavoring agent.

20. The oral formulation according to claim 16 , comprising from 0.5 to 20 mg of said 14-epi-analogue of vitamin D.

21. A method for treating rickets, osteoporosis, osteomalacia, psoriasis, multiple sclerosis or type I diabetes, hyperparathyroidism, or benign prostate hyperplasia comprising administering a formulation according to claim 1 to a human or animal patient in need thereof, wherein treating does not include preventing.

22. A method for preventing rickets, osteoporosis or osteomalacia comprising administering a formulation according to claim 1 to a human or animal patient in need thereof.

23. A method for improving the absorption of 14-epi-analogue of vitamin D over the formulation in medium chain triglyceride comprising administering a formulation according to claim 1 to a human or animal patient in need thereof, wherein the method is characterized by a higher AUC0-24 h than the corresponding formulation in medium chain triglycerides.

24. A method for treating a cancer selected from the group consisting of breast cancer, prostate cancer, lung cancer, colorectal cancer, bladder cancer, brain cancer, stomach cancer, kidney cancer, liver cancer, ovary cancer, mouth cancer, skin cancer, intestine cancer, uterine cancer, head and neck cancer and throat cancer, blood cancers, thyroid cancer, pancreatic cancer, acute myeloid leukemia and chronic lymphocytic leukemia comprising administering a formulation according to claim 1 to a human or animal patient in need thereof, wherein treating does not include preventing.

25. A method for improving the absorption of 14-epi-analogue of vitamin D over the formulation in medium chain triglyceride comprising administering a formulation according to claim 1 to a human or animal patient in need thereof, wherein the method is characterized by a higher Cmax than the corresponding formulation in medium chain triglycerides.

26. The method according to claim 25 , wherein the method is also characterized by a higher AUC0-24 h than the corresponding formulation in medium chain triglycerides.

27. A method for treating rickets, osteoporosis, osteomalacia, psoriasis, multiple sclerosis or type I diabetes, hyperparathyroidism or benign prostate hyperplasia comprising administering a formulation according to claim 6 to a human or animal patient in need thereof, wherein treating does not include preventing.

28. A method for preventing rickets, osteoporosis or osteomalacia comprising administering a formulation according to claim 6 to a human or animal patient in need thereof.

29. A method for treating a cancer selected from the group consisting of breast cancer, prostate cancer, lung cancer, colorectal cancer, bladder cancer, brain cancer, stomach cancer, kidney cancer, liver cancer, ovary cancer, mouth cancer, skin cancer, intestine cancer, uterine cancer, head and neck cancer and throat cancer, blood cancers, thyroid cancer, pancreatic cancer, acute myeloid leukemia and chronic lymphocytic leukemia comprising administering a formulation according to claim 6 to a human or animal patient in need thereof, wherein treating does not include preventing.

30. A method for treating rickets, osteoporosis, osteomalacia, psoriasis, multiple sclerosis or type I diabetes, hyperparathyroidism or benign prostate hyperplasia comprising administering a formulation according to claim 11 to a human or animal patient in need thereof, wherein treating does not include preventing.

31. A method for preventing rickets, osteoporosis or osteomalacia comprising administering a formulation according to claim 11 to a human or animal patient in need thereof.

32. A method for treating a cancer selected from the group consisting of breast cancer, prostate cancer, lung cancer, colorectal cancer, bladder cancer, brain cancer, stomach cancer, kidney cancer, liver cancer, ovary cancer, mouth cancer, skin cancer, intestine cancer, uterine cancer, head and neck cancer and throat cancer, blood cancers, thyroid cancer, pancreatic cancer, acute myeloid leukemia and chronic lymphocytic leukemia comprising administering a formulation according to claim 11 to a human or animal patient in need thereof, wherein treating does not include preventing.

33. A method for treating rickets, osteoporosis, osteomalacia, psoriasis, autoimmune diseases such as multiple sclerosis or type I diabetes, hyperparathyroidism or benign prostate hyperplasia comprising administering a formulation according to claim 16 to a human or animal patient in need thereof, wherein treating does not include preventing.

34. A method for preventing rickets, osteoporosis or osteomalacia comprising administering a formulation according to claim 16 to a human or animal patient in need thereof.

35. A method for treating a cancer selected from the group consisting of breast cancer, prostate cancer, lung cancer, colorectal cancer, bladder cancer, brain cancer, stomach cancer, kidney cancer, liver cancer, ovary cancer, mouth cancer, skin cancer, intestine cancer, uterine cancer, head and neck cancer and throat cancer, blood cancers, thyroid cancer, pancreatic cancer, acute myeloid leukemia and chronic lymphocytic leukemia comprising administering a formulation according to claim 16 to a human or animal patient in need thereof, wherein treating does not include preventing.