Method of treating vitamin B 12 deficiency

8,557,792

13/618654

September 14, 2012

A novel method and composition for treating vitamin B12 deficiency mammals that fail to respond to oral vitamin B12 therapy.

Castelli, Cristina (New York, NY, US); Kragie, Laura (Chevy Chase, MD, US)

Emisphere Technologies, Inc. (Roseland, NJ, US)

1. A tablet comprising (a) about 0.1 to about 20 mg of vitamin B 12 ; and (b) about 10 to about 200 mg of monosodium N-[8-(2-hydroxybenzoyl)amino]caprylate.

2. The tablet of claim 1 , wherein the tablet comprises about 0.5 to about 10 mg of vitamin B 12 .

3. The tablet of claim 1 , further comprising from about 0.5 to about 10 mg of povidone.

4. The tablet of claim 1 , further comprising from about 1 to about 8 mg of povidone.

5. The tablet of claim 1 , further comprising from about 1.5 to about 5 mg of povidone.

6. The tablet of claim 1 , wherein the vitamin B 12 is cyanocobalamin.

7. A tablet comprising (a) about 0.1 to about 1.5 mg of vitamin B 12 ; and (b) about 25 to about 150 mg of monosodium N-[8-(2-hydroxybenzoyl)amino]caprylate.

8. The tablet of claim 7 , further comprising from about 0.5 to about 10 mg of povidone.

9. The tablet of claim 7 , further comprising from about 1 to about 8 mg of povidone.

10. The tablet of claim 7 , further comprising from about 1.5 to about 5 mg of povidone.

11. The tablet of claim 7 , wherein the vitamin B 12 is cyanocobalamin.

12. A method of treating vitamin B 12 deficiency in a human subject in need thereof comprising orally administering the tablet of claim 1 .

13. A method of treating vitamin B 12 deficiency in a human subject in need thereof comprising orally administering the tablet of claim 7 .

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

15. The method of claim 13 , wherein said subject had failed to respond to existing oral vitamin B 12 treatment.

514/52

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