Compositions treating, preventing or reducing elevated metabolic levels

• US 6,528,496 B1
• Filed: 02/26/2001
• Issued: 03/04/2003
• Est. Priority Date: 12/29/1992
• Status: Expired due to Fees

• Current Assignee: Metabolite Laboratories Incorporated
• Original Assignee: Metabolite Laboratories Incorporated
• Inventors: Allen, Robert H., Stabler, Sally P.
• Primary Examiner(s): Housel, James
• Assistant Examiner(s): Lucas, Zachariah
• Application Number:
  US09/793,214
• Time in Patent Office: 736 Days
• Field of Search: 514/52, 514/249, 514/345, 514/251, 514/276, 514/335, 514/474, 514/563, 514/642, 514/745, 424/439, 424/557, 424/558, 424/643, 536/26.4, 435/88, 426/648
• US Class Current: 514/52
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/525 Isoalloxazines, e.g. riboflavins, vitamin B2
• CPC Class Codes: A61K 31/714 Cobalamins, e.g. cyanocobalamin, i.e. vitamin B12

Abstract

A method for orally administering vitamin preparations is described which combine vitamin B₁₂ (B₁₂, cobalamin) and folic acid (folate), with and without pyridoxine (B₆), for preventing and treating elevated serum homocysteine (HC), cystathionine (CT), methylmalonic acid (MMA), or 2-methylcitric acid (2-MCA) levels. These metabolites have been shown to be indicative of B₁₂ and/or folic acid deficiencies. Further, it is likely that a B₆ deficiency may be present with a B₁₂ or folate deficiency. The method of the invention is also for use in lowering serum HC, CT, MMA, or 2-MCA in patients with or at risk for neuropsychiatric, vascular, renal or hematologic diseases. The method of the present invention eliminates the costly and time consuming steps of distinguishing between vitamin deficiencies once a deficiency is found by measurement of serum metabolite levels. The present invention is of particular benefit to the populations at risk for elevated serum metabolite levels, such as the people over the age of 65, and populations that have or are at risk for neuropsychiatric, vascular, renal and hematologic diseases.

Claims

1. An oral vitamin formulation comprising approximately 2.0 mg vitamin B₁₂ and 0.4 mg folic acid.

2. The formulation of claim 1, further comprising 5-75 mg vitamin B₆.

3. The formulation of claim 2, having approximately 25 mg vitamin B₆.

4. An oral vitamin formulation, comprising approximately 2 mg vitamin B₁₂ and 1.0 mg folic acid.

5. The formulation of claim 4, further comprising 5-75 mg vitamin B₆.

6. The formulation of claim 5, having approximately 25 mg vitamin B₆.

7. An oral vitamin formulation comprising approximately 2.0 mg vitamin B₁₂ and 0.1-0.4 mg folic acid.

8. The formulation of claim 7, further comprising 5-75 mg vitamin B₆.

9. The formulation of claim 8, having approximately 25 mg vitamin B₆.

10. An oral vitamin formulation, comprising approximately 2 mg vitamin B₁₂, 0.4-10.0 mg folic acid, and further comprising 5-75 mg vitamin B₆.

11. The formulation of claim 10, having approximately 25 mg vitamin B₆.