Nutritional supplement to treat macular degeneration

• US 20020182266A1
• Filed: 03/23/2001
• Published: 12/05/2002
• Est. Priority Date: 03/23/2001
• Status: Active Grant

• Current Assignee: Bausch & Lomb Incorporated (Bausch Health Cos., Inc.), PF Consumer Healthcare 1 LLC (GlaxoSmithKline PLC), Government of the United States of America
• Original Assignee: Wyeth (Pfizer Inc.)
• Inventors: Bartels, Stephen Paul, Smith, James Cecil Jr., Kinoshita, Jin, Souerwine, David A., Bunce, George Edwin, Baustian, Cara Larraine, Ferris, Frederick L. III, Ellenbogen, Leon
• Granted Patent: US 6,660,297 B2
• Time in Patent Office: Days
• US Class Current: 424/630
• CPC Class Codes: A23L 33/105 Plant extracts, their artificial duplicates or their derivatives
• CPC Class Codes: A23L 33/15 Vitamins
• CPC Class Codes: A23L 33/155 Vitamins A or D
• CPC Class Codes: A23L 33/16 Inorganic salts, minerals or trace elements
• CPC Class Codes: A23L 5/44 using carotenoids or xanthophylls
• CPC Class Codes: A23V 2002/00 Food compositions, function of food ingredients or processes for food or foodstuffs
• CPC Class Codes: A23V 2250/1588 Copper
• CPC Class Codes: A23V 2250/1642 Zinc
• CPC Class Codes: A23V 2250/2104 Anthocyanins
• CPC Class Codes: A23V 2250/211 Carotene, carotenoids
• CPC Class Codes: A23V 2250/2132 Other phenolic compounds, polyphenols
• CPC Class Codes: A23V 2250/702 Vitamin A
• 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 31/07 Retinol compounds, e.g. vitamin A retinoic acids A61K31/203
• 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 33/34 Copper; Compounds thereof
• CPC Class Codes: A61P 27/02 : Ophthalmic agents
• CPC Class Codes: A61P 27/12 : for cataracts
• CPC Class Codes: A61P 3/02 : Nutrients, e.g. vitamins, minerals

Abstract

A nutritional or dietary supplement composition that strengthens and promotes retinal health through the prevention, stabilization, reversal and/or treatment of visual acuity loss by reducing the risk of developing late stage or advanced age-related macular degeneration in persons with early age-related macular degeneration. The nutritional or dietary supplement composition may likewise reduce the risk of vision loss associated with the development of cataracts. The essential ingredients of the nutritional or dietary supplement composition are vitamin C, vitamin E, beta-carotene, zinc and copper. The essential ingredients are preferably provided in a tablet form suitable for oral ingestion. Preferably the composition is taken in the form of one or two tablets taken twice daily.

Claims

1. A composition comprising:

approximately 7 to 10 times the RDA of vitamin C;

approximately 13 to 18 times the RDA of vitamin E;

approximately 6 to 10 times the RDA of vitamin A in the form of beta-carotene;

approximately 4 to 7 times the RDA of zinc; and

approximately the RDA of copper.

7. The composition of claim 1, 2 or 3 wherein said composition comprises not less than approximately 450 mg vitamin C, not less than approximately 400 IU vitamin E, not less than approximately 17.2 mg beta-carotene, not less than approximately 68 mg zinc and not less than approximately 1.6 mg copper.

8. The composition of claim 1, 2 or 3 wherein said vitamin C is provided in the form of ascorbic acid.

9. The composition of claim 1, 2 or 3 wherein said vitamin E is provided in the form of dl-alpha tocopheryl acetate.

10. The composition of claim 1, 2 or 3 wherein said beta-carotene is substituted or supplemented with lutein, zeaxanthine or a raw material combination thereof.

11. The composition of claim 1, 2 or 3 wherein said composition is supplemented with alpha-lipoic acid, phenolic compounds, anthocyanosides or a combination thereof.

12. The composition of claim 1, 2 or 3 wherein said zinc is provided in the form of zinc oxide, zinc gluconate or a combination thereof.

13. The composition of claim 1, 2 or 3 wherein said copper is provided in the form of cupric oxide, copper gluconate or a combination thereof.

21. The composition of claim 1, 2 or 3 wherein said composition is formed into one or more tablets for daily oral ingestion by a human or other mammal.

22. The composition of claim 1, 2 or 3 wherein said composition is formed into four tablets for oral ingestion by a patient of two tablets twice daily.

2. A retinal health strengthening composition comprising:

approximately 7 to 10 times the RDA of vitamin C;

approximately 13 to 18 times the RDA of vitamin E;

approximately 6 to 10 times the RDA of vitamin A in the form of beta-carotene;

approximately 4 to 7 times the RDA of zinc; and

approximately the RDA of copper.

3. A nutritional or dietary supplement composition to safely and effectively prevent, stabilize, reverse and/or treat visual acuity loss by reducing the risk of developing late stage or advanced age-related macular degeneration in persons with early age-related macular degeneration and by reducing the risk of vision loss associated with the formation of cataracts and the progression of age-related macular degeneration comprising:

approximately 7 to 10 times the RDA of vitamin C;

approximately 13 to 18 times the RDA of vitamin E;

approximately 6 to 10 times the RDA of vitamin A in the form of beta-carotene;

approximately 4 to 7 times the RDA of zinc; and

approximately the RDA of copper.

4. A method of safely and effectively preventing, stabilizing, reversing and/or treating visual acuity loss by reducing the risk of developing late stage or advanced age-related macular degeneration in persons with early age-related macular degeneration and by reducing the risk of vision loss associated with the development of cataracts and the progression of age-related macular degeneration comprising:

administering a daily dosage of not less than approximately 420 mg and not more than approximately 600 mg vitamin C, not less than approximately 400 IU and not more than approximately 540 IU vitamin E, not less than approximately 17.2 mg and not more than approximately 28 mg beta-carotene, carotene, not less than approximately 60 mg and not more than approximately 100 mg zinc and not less than approximately 1.6 mg and not more than approximately 2.4 mg copper.

15. The method of claim 4, 5 or 6 wherein said vitamin C is provided in the form of ascorbic acid.

16. The method of claim 4, 5 or 6 wherein said vitamin E is provided in the form of dl-alpha tocopheryl acetate.

17. The method of claim 4, 5 or 6 wherein said beta-carotene is substituted or supplemented with lutein, zeaxanthine, or a raw material combination thereof.

18. The method of claim 4, 5 or 6 wherein said composition is supplemented with alpha-lipoic acid, phenolic compounds, anthocyanosides or a combination thereof.

19. The method of claim 4, 5 or 6 wherein said zinc is provided in the form of zinc oxide, zinc gluconate or a combination thereof.

20. The method of claim 4, 5 or 6 wherein said copper is provided in the form of copper oxide, copper gluconate or a combination thereof.

23. The method of claim 4 wherein said daily dosage is administered orally in the form of one or more tablets taken daily.

24. The method of claim 4 wherein said daily dosage is administered orally in the form of two tablets taken twice daily.

5. A method of manufacturing a nutritional supplement composition that is safe and effective in preventing, stabilizing, reversing and/or treating visual acuity loss by reducing the risk of developing late stage or advanced age-related macular degeneration in persons with early age-related macular degeneration and by reducing the risk of vision loss associated with the development of cataracts and the progression of age-related macular degeneration comprising:

blending not less than approximately 420 mg and not more than approximately 600 mg vitamin C, not less than approximately 400 IU and not more than approximately 540 IU vitamin E, not less than approximately 17.2 mg and not more than approximately 28 mg beta-carotene, not less than approximately 60 mg and not more than approximately 100 mg zinc and not less than approximately 1.6 mg and not more than approximately 2.4 mg copper into a suitable dosage form.

14. The method of claim 5 or 6 wherein said blend provides not less than approximately 450 mg vitamin C, not less than approximately 400 IU vitamin E, not less than approximately 17.2 mg beta-carotene, not less than approximately 68 mg zinc, and not less than approximately 1.6 mg copper, up until an expiration date of said dosage form produced from said blend.

25. The method of claim 5 or 6 wherein said composition is compressed in the form of two tablets taken twice daily.

6. A method of manufacturing a composition comprising:

blending not less than approximately 420 mg and not more than approximately 600 mg vitamin C, not less than approximately 400 IU and not more than approximately 540 IU vitamin E, not less than approximately 17.2 mg and not more than approximately 28 mg beta-carotene, not less than approximately 60 mg and not more than approximately 100 mg zinc and not less than approximately 1.6 mg and not more than approximately 2.4 mg copper into a suitable dosage form.