Pharmaceutical formulations and methods for treating patients suffering from diseases that cause muscular hypotonia
First Claim
1. A pharmaceutical formulation for the treatment of a disorder having muscular hypotonia as a symptom, selected from the group of an Alzheimer'"'"'s disease, atrophy of the brain, atrophy of the cerebellum, Fragile X syndrome, mental retardation of unknown causes, multiple anomalies in the chromosomes, deletion in one or more chromosome, and fragility in a chromosome other than the X chromosome, said formulation comprising non toxic quantities of the following components in a pharmaceutically acceptable excipient:
- a. about 0.05 to about 200 mg of gamma amino burytic acid (GABA);
b. about 50 to about 300 mg of an antioxidant selected from the group consisting of vitamin E, ascorbic acid, and mixtures thereof;
c. about 100 to about 300 mg of folic acid;
d. about 0.05 to about 0-5 mg of a nicotinamide selected from the group consisting of nicotinamide and pharmaceutically acceptable salts thereof; and
e. about 25 to about 100 mg of a lithium salt selected from the group consisting of lithium carbonate, lithium bromide, lithium chloride, and lithium acetate.
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Accused Products
Abstract
Formulations are provided for the treatment of patients suffering from disorders that have in common the appearance of muscular hypotonia as a symptom. These disorders include Alzheimer'"'"'s type diseases, atrophy of the brain, atrophy of the cerebellum, Fragile X syndrome, mental retardation of unknown causes, multiple anomalies in the chromosomes, deletions in one or more chromosome, and fragility in a chromosome other than the X chromosome. The formulations of the invention contain therapeutically effective amounts of gamma amino butyric acid (GABA), an anti-oxidant (such as ascorbic acid and/or vitamin E), folic acid, nicotinamide, and a lithium salt, all in a pharmaceutically acceptable excipient. Methods for the treatment of these disorders by the administration of such formulations are also provided.
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Citations
12 Claims
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1. A pharmaceutical formulation for the treatment of a disorder having muscular hypotonia as a symptom, selected from the group of an Alzheimer'"'"'s disease, atrophy of the brain, atrophy of the cerebellum, Fragile X syndrome, mental retardation of unknown causes, multiple anomalies in the chromosomes, deletion in one or more chromosome, and fragility in a chromosome other than the X chromosome, said formulation comprising non toxic quantities of the following components in a pharmaceutically acceptable excipient:
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a. about 0.05 to about 200 mg of gamma amino burytic acid (GABA); b. about 50 to about 300 mg of an antioxidant selected from the group consisting of vitamin E, ascorbic acid, and mixtures thereof; c. about 100 to about 300 mg of folic acid; d. about 0.05 to about 0-5 mg of a nicotinamide selected from the group consisting of nicotinamide and pharmaceutically acceptable salts thereof; and e. about 25 to about 100 mg of a lithium salt selected from the group consisting of lithium carbonate, lithium bromide, lithium chloride, and lithium acetate. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10)
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11. A method for the treatment of a patient suffering from a disorder having muscular hypotonia as a symptom, said disorder selected from the group of an Alzheimer'"'"'s disease, atrophy of the brain, atrophy of the cerebellum, Fragile X syndrome, mental retardation of unknown causes, multiple anomalies in the chromosomes, deletion in one or more chromosome, and fragility in a chromosome other than the X chromosome, said method comprising administering to said patient therapeutically effective daily dosages of the following components:
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a. about 0.05 to about 200 mg of gamma amino burytic acid (GABA); b. about 50 to about 300 mg of an antioxidant selected from the group consisting of vitamin E, ascorbic acid, and mixtures thereof; c. about 100 to about 300 mg of folic acid; d. about 0.05 to about 0.5 mg of a nicotinamide selected from the group consisting of nicotinimide and pharmaceutically acceptable salts thereof; e. about 25 to about 100 mg of a lithium salt selected from the group consisting of lithium carbonate, lithium bromide, lithium chloride, and lithium acetate.
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12. A method for the treatment of a patient suffering from a disorder having muscular hypotonia as a symptom, said disorder selected from the group of an Alzheimer'"'"'s disease, atrophy of the brain, atrophy of the cerebellum, Fragile X syndrome, mental retardation of unknown causes, multiple anomalies in the chromosomes, deletion in one or more chromosome, and fragility in a chromosome other than the X chromosome said method comprising administering to said patient therapeutically effective daily dosages of the following components:
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about 50 to about 400 mg of gamma amino burytic acid (GABA); b. about 75 to about 600 mg of the antioxidant vitamin E and about 0.25 to 2.0 mg of the antioxidant ascorbic acid; c. about 100 to about 800 mg of folic acid; d. about 0.05 to about 0°
4 mg of nicotinamide;e. about 25 to about 100 mg of lithium carbonate.
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Specification