Ocular formulations with neuroprotectants to reduce Alzheimer and neurotoxic risks created by large zinc dosages

• US 20060039954A1
• Filed: 05/18/2005
• Published: 02/23/2006
• Est. Priority Date: 12/23/2003
• Status: Abandoned Application

• Current Assignee: Dennis L. Gierhart, Dorey C. Kathleen, Patrick D. Kelly
• Original Assignee: Dennis L. Gierhart, Dorey C. Kathleen, Patrick D. Kelly
• Inventors: Gierhart, Dennis L., Kelly, Patrick D., Dorey, C. Kathleen
• Application Number:
  US11/133,125
• Publication Number:
  US 20060039954A1
• Time in Patent Office: Days
• US Class Current: 424/439
• CPC Class Codes: A23L 33/105 Plant extracts, their artificial duplicates or their derivatives
• CPC Class Codes: A23L 33/16 Inorganic salts, minerals or trace elements
• CPC Class Codes: A23V 2002/00 Food compositions, function of food ingredients or processes for food or foodstuffs
• CPC Class Codes: A23V 2250/1642 Zinc
• CPC Class Codes: A23V 2250/21 Plant extracts
• CPC Class Codes: A23V 2250/708 Vitamin C
• CPC Class Codes: A23V 2250/712 Vitamin E
• 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 31/12 Ketones
• CPC Class Codes: A61K 31/355 Tocopherols, e.g. vitamin E
• CPC Class Codes: A61K 31/375 Ascorbic acid, i.e. vitamin C; Salts thereof
• CPC Class Codes: A61K 33/30 Zinc; Compounds thereof
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca

Abstract

Formulations marketed to elderly consumers for preventing or treating age-related eye diseases such as macular degeneration are modified in various four ways, compared to the formulations tested in the first “Age-Related Eye Disease Study” (AREDS-1) clinical trial. Zinc dosages are substabtially reduced, to reduce the risk of Alzheimer'"'"'s disease and other neurotoxic damage in the brains of elderly people, and zeaxanthin is substituted for a substantial portion of any beta-carotene. Additional useful agents are also disclosed.

Claims

1. A nutrient formulation for preventing or treating at least one ocular disorder in mammals, wherein said nutrient formulation comprises:

a. zeaxanthin, in a daily dosage of at least about 3 milligrams;

b. elemental zinc, in a daily dosage of about 15 to about 40 milligrams,

wherein said nutrient formulation is also characterized by an absence of beta-carotene at a daily dosage higher than twice the recommended daily allowance.

2. A nutrient formulation of claim 1, comprising zeaxanthin in a daily dosage of at least about 5 milligrams.

3. A nutrient formulation of claim 1, comprising zeaxanthin in a daily dosage of at least about 10 milligrams.

4. A nutrient formulation of claim 1, comprising elemental zinc in a daily dosage of 30 to 40 milligrams.

5. A nutrient formulation of claim 1, which also contains at least one additional neuroprotective agent selected from the group consisting of mitochondrial boosting compounds, glutathioone boosting compounds, carnosine, agents that stimulate methionine sulfoxide reductase enzymes, and plant-derived flavonoids.

6. A nutrient formulation of claim 1, which also contains Vitamin C and Vitamin E.

7. The nutrient formulation of claim 1, which is in a unit dosage form.

8. The nutrient formulation of claim 7, wherein the unit dosage form is selected from the group consisting of capsules, tablets, liquids accompanied by instructions for consumers to ingest a measured volume of liquid each day, and powdered or granular formulations accompanied by instructions for consumers to ingest a measured volume of powdered or granular formulation each day.

9. The nutrient formulation of claim 1, wherein the nutrient formulation has been added to and is contained within a food or beverage material.

10. A method of manufacturing a nutritional supplement for preventing or treating ocular disorders, comprising the step of incorporating into said nutritional supplement:

a. zeaxanthin, in a daily dosage of at least about 3 milligrams;

b. elemental zinc, in a daily dosage of about 15 to about 40 milligrams,

wherein said nutrient formulation is also characterized by an absence of beta-carotene at a daily dosage higher than twice the recommended daily allowance.

11. The method of claim 10, wherein said nutrient formulation is in a unit dosage form.