Method of treating vitamin B12 deficiency

1. A method for treating vitamin B 12 deficiency in a subject in need thereof, comprising orally administering to the subject a pharmaceutical composition comprising (1) vitamin B 12 and (2) a compound selected from N-[8-(2-hydroxybenzoyl)amino]caprylic acid and pharmaceutically acceptable salts thereof, wherein the pharmaceutical composition comprises an effective amount of the compound such that, upon oral administration of the pharmaceutical composition, the T max of the vitamin B 12 is decreased.

2. The method of claim 1 , wherein said subject has 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 3 , wherein said tablet comprises from about 0.01 mg to about 25 mg of vitamin B 12 and from about 1 mg to about 600 mg of monosodium N-[8-(2-hydroxybenzoyl)amino]caprylate.

5. The method of claim 3 , wherein said tablet comprises from about 0.02 mg to about 25 mg of vitamin B 12 .

6. The method of claim 3 , wherein said tablet comprises from about 0.1 mg to about 20 mg of vitamin B 12 .

7. The method of claim 3 , wherein said tablet comprises about 0.5 mg of vitamin B 12 and about 17.5 mg of monosodium N-[8-(2-hydroxybenzoyl) amino]caprylate.

8. 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.

9. The method of claim 8 , wherein said weight ratio is from about 1:2 to about 1:600.

10. The method of claim 8 , wherein said weight ratio is from about 1:3 to about 1:20.

11. The method of claim 8 , wherein said weight ratio is about 1:4.

12. The method of claim 8 , wherein said weight ratio is from about 1:500 to about 1:700.

13. The method of claim 3 , wherein said pharmaceutical composition further comprises at least one of a carrier, excipient, emulsifier, stabilizer, sweetener, flavoring agent, diluent, coloring agent, solubilizing agent or combinations thereof.

14. An oral pharmaceutical composition comprising (1) vitamin B 12 and (2) an effective amount of a compound selected from N-[8-(2-hydroxybenzoyl)amino]caprylic acid and pharmaceutically acceptable salts thereof such that, upon oral administration of the pharmaceutical composition, the T max of the vitamin B 12 is decreased.

15. The pharmaceutical composition of claim 14 , wherein said pharmaceutical composition is in the form of a tablet.

16. The pharmaceutical composition of claim 15 , wherein said tablet comprises from about 0.01 mg to about 25 mg of vitamin B 12 and from about 50 mg to about 600 mg of monosodium N-[8-(2-hydroxybenzoyl)amino]caprylate.

17. The pharmaceutical composition of claim 15 , wherein said tablet comprises from about 0.02 mg to about 20 mg of vitamin B 12 .

18. The pharmaceutical composition of claim 15 , wherein said tablet comprises from about 0.1 mg to about 10 mg of vitamin B 12 .

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

20. The pharmaceutical composition of claim 14 , further comprising at least one of a carrier, excipient, emulsifier, stabilizer, sweetener, flavoring agent, diluent, coloring agent, solubilizing agent or combinations thereof.

21. An oral pharmaceutical composition comprising 0.5 to 10 mg of vitamin B 12 and from 10 to 200 mg of monosodium N-[8-(2-hydroxybenzoyl)amino]caprylate, wherein the pharmaceutical composition comprises an effective amount of monosodium N-[8-(2-hydroxybenzoyl)amino]caprylate such that, upon oral administration of the pharmaceutical composition, the T max of the vitamin B 12 is decreased.

22. The oral pharmaceutical composition of claim 21 , wherein the pharmaceutical composition is a tablet.

23. A method of treating vitamin B 12 deficiency in a subject in need thereof, the method comprising orally administering to the subject a pharmaceutical composition comprising 0.5 to 10 mg of vitamin B 12 and from 10 to 200 mg of monosodium N-[8-(2-hydroxybenzoyl)amino]caprylate, wherein the pharmaceutical composition comprises an effective amount of monosodium N-[8-(2-hydroxybenzoyl)amino]caprylate such that, upon oral administration of the pharmaceutical composition, the T max of the vitamin B 12 is decreased.

24. The method of claim 23 , wherein the subject is a human.

25. The method of claim 1 , wherein, upon oral administration, the pharmaceutical composition exhibits a mean T max for the vitamin B 12 of 0.50 hours.

26. The pharmaceutical composition of claim 14 , wherein the pharmaceutical composition exhibits a mean T max for the vitamin B 12 of 0.50 hours.

27. The pharmaceutical composition of claim 21 , wherein, upon oral administration, the pharmaceutical composition exhibits a mean T max for the vitamin B 12 of 0.50 hours.

28. The method of claim 23 , wherein the pharmaceutical composition exhibits a mean T max for the vitamin B 12 of 0.50 hours.

29. The oral pharmaceutical composition of claim 14 , wherein the oral 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.