IP Library › Granted Patent US 8,288,360
Granted Patent B2
US 8,288,360 · App. 13/206,090 · Granted Oct 16, 2012

Method of treating vitamin B

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Quick Facts
Patent No.
US 8,288,360
App. No.
13/206,090
Granted
Oct 16, 2012
Kind
B2
Abstract

A novel method and composition for treating vitamin B 12 deficiency mammals that fail to respond to oral vitamin B 12 therapy.

Claims (36)

1. A method for administering vitamin B 12 to a subject to treat vitamin B 12 deficiency, comprising orally administering a pharmaceutical composition comprising (1) from about 0.01 mg to about 25 mg of vitamin B 12 and (2) from about 1 mg to about 600 mg of at least one substance selected from N-[8-(2-hydroxybenzoyl) amino]caprylic acid and its pharmaceutically acceptable salts to said subject.

2. The method of claim 1 , wherein said subject had failed to respond to existing oral vitamin B 12 treatment.

3. The method of claim 1 , wherein said pharmaceutical composition is a tablet.

4. The method of claim 1 , wherein said pharmaceutical composition has a weight ratio of vitamin B 12 to monosodium N-[8-(2-hydroxybenzoyl) amino]caprylate of from about 2:1 to about 1:700.

5. The method of claim 4 , wherein said weight ratio is from about 1:2 to about 1:600.

6. The method of claim 4 , wherein said weight ratio is from about 1:3 to about 1:20.

7. The method of claim 1 , wherein said further comprises at least one of a carrier, excipient, emulsifier, stabilizer, sweetener, flavoring agent, diluent, coloring agent, solubilizing agent or combinations thereof.

8. An oral pharmaceutical composition comprising (1) from about 0.01 mg to about 25 mg of vitamin B 12 and (2) from about 1 mg to about 600 mg of at least one substance selected from N-[8(2-hydroxybenzoyl) amino]caprylic acid and its pharmaceutically acceptable salts.

9. The pharmaceutical composition of claim 8 , wherein said pharmaceutical composition comprises a tablet.

10. The pharmaceutical composition of claim 9 , wherein said tablet comprises from about 0.01 to about 25 mg of vitamin B 12 and from about 50 to about 600 mg of monosodium N-[8-(2-hydroxybenzoyl) amino]caprylate.

11. The pharmaceutical composition of claim 9 , wherein said tablet comprises from about 1 to about 15 mg of vitamin B 12 and from about 50 to about 200 mg of monosodium N-[8-(2-hydroxybenzoyl) amino]caprylate.

12. The pharmaceutical composition of claim 8 , further comprising at least one of a carrier, excipient, emulsifier, stabilizer, sweetener, flavoring agent, diluent, coloring agent, solubilizing agent or combinations thereof.

13. The method of claim 1 , wherein said pharmaceutical composition comprises about 0.1 to 1.5 mg of vitamin B 12 and from 25 to 100 mg of monosodium N-[8-(2-hydroxybenzoyl) amino]caprylate.

14. The method of claim 1 , wherein the vitamin B 12 is a cobalamin.

15. The method of claim 1 , wherein the vitamin B 12 is cyanocobalamin.

16. The method of claim 1 , wherein the vitamin B 12 is hydroxocobalamin.

17. The method of claim 1 , wherein the vitamin B 12 is methylcobalamin.

18. The method of claim 1 , wherein the vitamin B 12 is 5-deoxyadenosylcobalamin.

19. The method of claim 13 , wherein the vitamin B 12 is a cobalamin.

20. The method of claim 13 , wherein the vitamin B 12 is cyanocobalamin.

21. The method of claim 13 , wherein the vitamin B 12 is hydroxocobalamin.

22. The method of claim 13 , wherein the vitamin B 12 is methylcobalamin.

23. The method of claim 13 , wherein the vitamin B 12 is 5-deoxyadenosylcobalamin.

24. The oral pharmaceutical composition of claim 8 , wherein said pharmaceutical composition comprises about 0.1 to 1.5 mg of vitamin B 12 and from 25 to 100 mg of monosodium N-[8-(2-hydroxybenzoyl) amino]caprylate.

25. The oral pharmaceutical composition of claim 8 , wherein the vitamin B 12 is a cobalamin.

26. The oral pharmaceutical composition of claim 8 , wherein the vitamin B 12 is cyanocobalamin.

27. The oral pharmaceutical composition of claim 8 , wherein the vitamin B 12 is hydroxocobalamin.

28. The oral pharmaceutical composition of claim 8 , wherein the vitamin B 12 is methylcobalamin.

29. The oral pharmaceutical composition of claim 8 , wherein the vitamin B 12 is 5-deoxyadenosylcobalamin.

30. The oral pharmaceutical composition of claim 24 , wherein the vitamin B 12 is a cobalamin.

31. The oral pharmaceutical composition of claim 24 , wherein the vitamin B 12 is cyanocobalamin.

32. The oral pharmaceutical composition of claim 24 , wherein the vitamin B 12 is hydroxocobalamin.

33. The oral pharmaceutical composition of claim 24 , wherein the vitamin B 12 is methylcobalamin.

34. The oral pharmaceutical composition of claim 24 , wherein the vitamin B 12 is 5-deoxyadenosylcobalamin.

35. The method of claim 1 , wherein the substance in component (2) is monosodium N-[8-(2-hydroxybenzoyl)amino]caprylate.

36. The oral pharmaceutical of claim 8 , wherein the substance in component (2) is monosodium N-[8-(2-hydroxybenzoyl)amino]caprylate.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 22, 2021
From: EMISPHERE TECHNOLOGIES, INC.
To: NOVO NORDISK NORTH AMERICA OPERATIONS A/S
Reel/Frame 056750/0169 →