Oral B12 Therapy

1 . A method of rapidly normalizing vitamin B 12 levels in a patient having a vitamin B 12 deficiency and an average vitamin B 12 level below about 350 pg/mL, comprising daily administering for at least 15 days one or more oral dosage forms comprising (i) N-[8-(2-hydroxybenzoyl) amino]caprylic acid or a pharmaceutically acceptable salt thereof, (ii) vitamin B 12 , and optionally (iii) folic acid, wherein the daily total amount of N-[8-(2-hydroxybenzoyl) amino]caprylic acid or a pharmaceutically acceptable salt thereof is from about 50 to about 250 mg and the daily total amount of vitamin B 12 is from about 0.5 to about 2 mg, wherein the vitamin B 12 level in the patient is normalized within 15 days.

2 . The method of claim 1 , wherein the patient has an average vitamin B 12 level below about 200 pg/mL.

3 . The method of claim 1 , wherein one dosage form comprising 100 mg of sodium N-[8-(2-hydroxybenzoyl) amino]caprylate and 1 mg of cyanocobalamin is administered daily.

4 . A method of normalizing active vitamin B 12 in a patient in need thereof, wherein the patient has an active vitamin B 12 level below about 100 pmol/L, the method comprising daily administering one or more oral dosage forms comprising (i) N-[8-(2-hydroxybenzoyl) amino]caprylic acid or a pharmaceutically acceptable salt thereof, (ii) vitamin B 12 , and optionally (iii) folic acid, wherein the daily total amount of N-[8-(2-hydroxybenzoyl) amino]caprylic acid or a pharmaceutically acceptable salt thereof is from about 50 to about 250 mg and the daily total amount of vitamin B 12 is from about 0.5 to about 2 mg, wherein the active vitamin B 12 level in the patient is normalized within 15 days.

5 . The method of claim 4 , wherein the patient has an active vitamin B 12 level below about 50 pmol/L

6 . The method of claim 4 , wherein one dosage form comprising 100 mg of sodium N-[8-(2-hydroxybenzoyl) amino]caprylate and 1 mg of cyanocobalamin is administered daily.

7 . A method of reducing methyl malonic acid (MMA) levels in a patient having elevated MMA levels, wherein the patient has an MMA level of at least 150 nmol/L, the method comprising daily administering one or more oral dosage forms comprising (i) N-[8-(2-hydroxybenzoyl) amino]caprylic acid or a pharmaceutically acceptable salt thereof, (ii) vitamin B 12 , and optionally (iii) folic acid, wherein the daily total amount of N-[8-(2-hydroxybenzoyl) amino]caprylic acid or a pharmaceutically acceptable salt thereof is from about 50 to about 250 mg and the daily total amount of vitamin B 12 is from about 0.5 to about 2 mg, wherein the MMA levels in the patient are normalized within 15 days.

8 . The method of claim 7 , wherein the patient has an MMA level of at least 175 nmol/L.

9 . The method of claim 7 , wherein the patient has a vitamin B 12 level below about 350 pg/mL.

10 . The method of claim 7 , wherein one dosage form comprising 100 mg of sodium N-[8-(2-hydroxybenzoyl) amino]caprylate and 1 mg of cyanocobalamin is administered daily.

11 . A method of reducing homocysteine levels in a patient having elevated homocysteine levels, wherein the patient has a homocysteine level of at least 13 nmol/L, the method comprising daily administering one or more oral dosage forms comprising (i) N-[8-(2-hydroxybenzoyl) amino]caprylic acid or a pharmaceutically acceptable salt thereof, (ii) vitamin B 12 , and optionally (iii) folic acid, wherein the daily total amount of N-[8-(2-hydroxybenzoyl) amino]caprylic acid or a pharmaceutically acceptable salt thereof is from about 50 to about 250 mg and the daily total amount of vitamin B 12 is from about 0.5 to about 2 mg, wherein the homocysteine level in the patient are normalized within 15 days.

12 . The method of claim 11 , wherein the patient has an homocysteine level of at least 14 nmol/L.

13 . The method of claim 11 , wherein the patient has a vitamin B 12 level below about 350 pg/mL.

14 . The method of claim 11 , wherein one dosage form comprising 100 mg of sodium N-[8-(2-hydroxybenzoyl) amino]caprylate and 1 mg of cyanocobalamin is administered daily.

15 . A method of reducing intersubject variability in the oral treatment of patients suffering from vitamin B 12 deficiency, the method comprising, for each patient, daily administering for at least 15 days one or more oral dosage forms comprising (i) N-[8-(2-hydroxybenzoyl) amino]caprylic acid or a pharmaceutically acceptable salt thereof, (ii) vitamin B 12 , and optionally (iii) folic acid, wherein the daily total amount of N-[8-(2-hydroxybenzoyl) amino]caprylic acid or a pharmaceutically acceptable salt thereof is from about 50 to about 250 mg and the daily total amount of vitamin B 12 is from about 0.5 to about 2 mg.

16 . An oral dosage form comprising:

(a) vitamin B 12 ;

(b) N-[8-(2-hydroxybenzoyl) amino]caprylic acid or a pharmaceutically acceptable salt thereof; and

(c) folic acid.

17 . The oral dosage form of claim 16 , wherein the dosage form comprises from about 50 to about 250 mg of N-[8-(2-hydroxybenzoyl) amino]caprylic acid or a pharmaceutically acceptable salt thereof, and from about 0.5 to about 2 mg of vitamin B 12 .

18 . An oral dosage form comprising:

(a) a proton pump inhibitor;

(b) vitamin B 12 ;

(c) sodium N-[8-(2-hydroxybenzoyl) amino]caprylate; and

(d) folic acid.

19 . The oral dosage form of claim 18 , wherein the dosage form comprises from about 50 to about 250 mg of N-[8-(2-hydroxybenzoyl) amino]caprylic acid or a pharmaceutically acceptable salt thereof, and from about 0.5 to about 2 mg of vitamin B 12 .

20 . An oral dosage form comprising:

(a) metformin;

(b) vitamin B 12 ;

(c) sodium N-[8-(2-hydroxybenzoyl) amino]caprylate; and

(d) folic acid.

21 . The oral dosage form of claim 20 , wherein the dosage form comprises from about 50 to about 250 mg of N-[8-(2-hydroxybenzoyl) amino]caprylic acid or a pharmaceutically acceptable salt thereof, and from about 0.5 to about 2 mg of vitamin B 12 .