Controlled release lipoic acid
AssigneeMedical Research Institute
InventorEdward A. Byrd
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Abstract
A controlled release formulation of lipoic acid is disclosed. The lipoic acid is combined with excipient materials in such a way that those materials provide for gradual release of the lipoic acid in a manner which makes it possible to substantially increase the period of time over which therapeutic levels of lipoic acid are maintained relative to a quick release formulation. These features make it possible to use lipoic acid to reduce serum glucose levels and maintain those levels over time thereby obtaining a range of desired therapeutic results.
Claims20
A controlled release oral dosage formulation, comprising:
- a therapeutically effective amount of lipoic acid;
- and
- an excipient material comprising a polymer;
- wherein the formulation is characterized by releasing the lipoic acid in a manner so as to increase a period of time over which a therapeutic level of lipoic acid is maintained by 50% or more as compared to a quick release formulation.
A method for reducing serum glucose in a patient with diabetes mellitus type 2, comprising:
- administering to a human patient suffering from diabetes mellitus type 2 a controlled release formulation comprising an organic polymer and lipoic acid which formulation is characterized by maintaining a therapeutic level of lipoic acid in the patient's circulatory system over a period of time which is 50% or more greater than that obtained with a quick release formulation;
- and
- repeating the administering on three or more consecutive days thereby maintaining a therapeutic level of lipoic acid in the patient's circulatory system over a therapeutically effective period of time on three or more consecutive days.
A method of reducing a human patient's A1c level, comprising:
- administering a therapeutically effective amount of an orally active antidiabetic selected from the group consisting of a sulfonylurea, a biguanide and a thiazolidinedione;
- and
- administering an oral, controlled release formulation of lipoic acid.
Dependencies are inferred from the claim text.