Oral b12 therapy
AssigneeEmisphere Technologies, Inc.
InventorCristina Castelli
Life of this patent
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Abstract
Methods of normalizing vitamin B12 levels in patients with low vitamin B12 and methods of normalizing intersubject variability in the treatment of such patients are described. Methods of reducing MMA and/or homocysteine levels, and pharmaceutical compositions useful to effect such changes are also described.
Claims21
A method of rapidly normalizing vitamin B12 levels in a patient having a vitamin B12 deficiency and an average vitamin B12 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, and (ii) vitamin B12, 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 B12 is from about 0.5 to about 2 mg, wherein the vitamin B12 level in the patient is normalized within 15 days.
A method of normalizing active vitamin B12 in a patient in need thereof, wherein the patient has an active vitamin B12 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, and (ii) vitamin B12, 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 B12 is from about 0.5 to about 2 mg, wherein the active vitamin B12 level in the patient is normalized within 15 days.
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, and (ii) vitamin B12, 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 B12 is from about 0.5 to about 2 mg, wherein the MMA levels in the patient are normalized within 15 days.
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, and (ii) vitamin B12, 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 B12 is from about 0.5 to about 2 mg, wherein the homocysteine level in the patient are normalized within 15 days.
A method of reducing intersubject variability in the oral treatment of patients suffering from vitamin B12 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, and (ii) vitamin B12, 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 B12 is from about 0.5 to about 2 mg.
An oral dosage form comprising:
- (a) vitamin B12;
- (b) N-[8-(2-hydroxybenzoyl) amino]caprylic acid or a pharmaceutically acceptable salt thereof;
- and
- (c) folic acid.
An oral dosage form comprising:
- (a) a proton pump inhibitor;
- (b) vitamin B12;
- (c) sodium N-[8-(2-hydroxybenzoyl) amino]caprylate;
- and
- (d) folic acid.
An oral dosage form comprising:
- (a) metformin;
- (b) vitamin B12;
- (c) sodium N-[8-(2-hydroxybenzoyl) amino]caprylate;
- and
- (d) folic acid.
Dependencies are inferred from the claim text.