Pharmaceutical compositions and methods for protecting and treating sun damaged skin

• US 5,804,168 A
• Filed: 01/29/1997
• Issued: 09/08/1998
• Est. Priority Date: 01/29/1997
• Status: Expired due to Term

• Current Assignee: Unilever N.V. (Unilever PLC)
• Original Assignee: Howard Murad
• Inventors: Murad, Howard
• Primary Examiner(s): Dodson, Shelley A.
• Application Number:
  US08/790,190
• Time in Patent Office: 587 Days
• Field of Search: 424/59, 424/60, 424/400, 424/401
• US Class Current: 424/59
• 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 2800/522 Antioxidants; Radical scavengers
• CPC Class Codes: A61K 31/28 Compounds containing heavy metals
• CPC Class Codes: A61K 31/35 having six-membered rings with one oxygen as the only ring hetero atom
• 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 36/076 Poria
• CPC Class Codes: A61K 36/16 Ginkgophyta, e.g. Ginkgoaceae (Ginkgo family)
• CPC Class Codes: A61K 36/185 Magnoliopsida (dicotyledons)
• CPC Class Codes: A61K 36/233 Bupleurum
• CPC Class Codes: A61K 36/28 Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
• CPC Class Codes: A61K 36/328 Commiphora, e.g. mecca myrrh or balm of Gilead
• CPC Class Codes: A61K 36/515 Gentiana
• CPC Class Codes: A61K 36/53 Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
• CPC Class Codes: A61K 36/70 Polygonaceae (Buckwheat family), e.g. spineflower or dock
• CPC Class Codes: A61K 36/71 Ranunculaceae (Buttercup family), e.g. larkspur, hepatica, hydrastis, columbine or goldenseal
• CPC Class Codes: A61K 36/734 Crataegus (hawthorn)
• CPC Class Codes: A61K 36/8945 Dioscorea, e.g. yam, Chinese yam or water yam
• CPC Class Codes: A61K 8/27 Zinc; Compounds thereof
• CPC Class Codes: A61K 8/671 Vitamin A; Derivatives thereof, e.g. ester of vitamin A acid, ester of retinol, retinol, retinal
• CPC Class Codes: A61K 8/676 : Ascorbic acid, i.e. vitamin C
• CPC Class Codes: A61K 8/678 : Tocopherol, i.e. vitamin E
• CPC Class Codes: A61K 8/9728 : Fungi, e.g. yeasts
• CPC Class Codes: A61K 8/9771 : Ginkgophyta, e.g. Ginkgoaceae [Ginkgo family]
• CPC Class Codes: A61K 8/9789 : Magnoliopsida [dicotyledons]
• CPC Class Codes: A61K 8/9794 : Liliopsida [monocotyledons]
• CPC Class Codes: A61K 8/986 : Milk; Derivatives thereof, e.g. butter
• CPC Class Codes: A61Q 17/04 : Topical preparations for affording protection against sunlight or other radiation; Topical sun tanning preparations
• CPC Class Codes: Y10S 977/918 : Immunological
• CPC Class Codes: Y10S 977/926 : Topical chemical, e.g. cosmetic or sunscreen

Abstract

This invention relates to a pharmaceutical composition for the protection and prevention of skin damage to a patient resulting from exposure to sunlight having at least one antioxidant component in an amount sufficient to inhibit the formation of free radicals; at least one anti-inflammatory component in an amount sufficient to substantially inhibit the inflammation associated with exposure to sunlight; and at least one immunity boosting component to enhance the patient'"'"'s immune response. In a preferred form, the composition also includes a cysteine component, a magnesium component, a manganese component, a copper component, a selenium component, and a carotenoid component. In a more preferred form the invention also includes wild yam root, wild yam extract, yellow dock, bupleurum, poria cocos, gentian root, myrrh gum, hawthorn berry extract, and rosemary extract. The invention also relates to a method for protecting skin from damage caused by exposure to sunlight by administering the pharmaceutical composition in an amount therapeutically effective in increasing the sun protection factor of the skin.

Claims

1. A pharmaceutical composition for the protection from or treatment of skin damage resulting from exposure to skin damaging light in a patient comprising:

at least one primary antioxidant component in an amount sufficient to reduce free radicals in the patient'"'"'s body;

at least one anti-inflammatory component in an amount sufficient to reduce inflammation of the patient'"'"'s skin; and

at least one immunity boosting component in an amount sufficient to stimulate the patient'"'"'s immune system response to protect skin or facilitate repair of damaged skin.

2. The pharmaceutical composition of claim 1, wherein the primary antioxidant component is present in about 5 to 50 weight percent, the anti-inflammatory component is present in about 5 to 40 weight percent, and the immunity boosting component is present in about 1 to 20 weight percent of the composition.

3. The pharmaceutical composition of claim 1, wherein the primary antioxidant component comprises at least one of a catechin-based preparation, a vitamin A source, a ginko biloba extract, a silymarin source, a quercetin compound, or a vitamin C source.

4. The pharmaceutical composition of claim 3, wherein the catechin-based preparation is a proanthanol or proanthocyanidin, the vitamin A source is vitamin A palmitate, the silymarin source is milk thistle extract, the quercitin compound is quercitin dihydrate, and the vitamin C source is an ascorbic acid compound, or a salt or ester thereof.

5. The pharmaceutical composition of claim 4, wherein the primary antioxidant component comprises proanthocyanidin present in about 0.1 to 5 weight percent, vitamin A palmitate present in about 0.1 to 5 weight percent, ginkgo biloba extract present in about 0.01 to 3 weight percent, the quercetin dihydrate and is present in about 1 to 20 weight percent, ascorbic acid present in about 5 to 50 weight percent, and milk thistle extract present in about 1 to 20 weight percent.

6. The pharmaceutical composition of claim 1, wherein the anti-inflammatory component comprises a vitamin E source, a zinc compound or a pharmaceutically acceptable salt thereof.

7. The pharmaceutical composition of claim 6, wherein the vitamin E source is a sulfate or succinate complex of vitamin E and the zinc compound is a complex of zinc and an amino acid.

8. The pharmaceutical composition of claim 7, wherein the vitamin E source is D-alpha tocopherol acid succinate present in about 5 to 40 weight percent, and the zinc compound is zinc monomethinone present in about 1 to 12 weight percent, wherein the zinc is preferably present in about 10 to 30 weight percent of the complex.

9. The pharmaceutical composition of claim 1, wherein the immunity boosting component comprises at least one of echinacea, an echinachea extract, or golden seal.

10. The pharmaceutical composition of claim 1, wherein the composition further comprises a pharmaceutically acceptable carrier or excipient.

11. The pharmaceutical composition of claim 1, further comprising one or more of a cysteine component, a magnesium component, manganese component, a copper component, a selenium component, or a carotenoid component.

12. The pharmaceutical composition of claim 11, wherein the cysteine component is N-acetyl cysteine and is present in about 1 to 10 weight percent, the magnesium component is magnesium ascorbate and is present in about 1 to 10 weight percent, wherein the magnesium is present in about 10 to 30 weight percent of the complex, the manganese component is manganese ascorbate and is present in about 0.5 to 10 weight percent, wherein manganese is present in about 5 to 20 weight percent of the complex, the copper component is copper sebacate and is present in about 0.01 to 5 weight percent, wherein the copper is present in about 5 to 20 weight percent of the complex, and the carotenoid component is beta carotene and is present in about 0.1 to 5 weight percent.

13. The pharmaceutical composition of claim 11, further comprising at least one of the wild yam root, wild yam extract, yellow dock, bupleurum, poria cocos, gentian root, myrrh gum, hawthorn berry extract, or rosemary extract.

14. The pharmaceutical composition of claim 13, wherein the amount of wild yam root, wild yam extract, marshmallow root, hawthorn berry extract, and rosemary extract, when present, is about 0.5 to 8 weight percent each, the amount of yellow dock, when present, is about 1 to 30 weight percent, and the amount of bupleurum, poria cocos, gentian root and myrrh, when present, is about 1 to 20 weight percent each.

15. A method for treating and protecting skin from damage caused by the exposure to sunlight, which comprises administering the pharmaceutical composition of claim 1 in therapeutically effective to increase the sun protection factor of the skin.

16. The method of claim 15, wherein the composition is administered orally.

17. The method of claim 16, wherein the composition is administered as a tablet or capsule having about 1 mg to 2,000 mg of composition.

18. The method of claim 17, wherein the tablet or capsule has about 400 mg to 1,600 mg of composition.

19. The method of claim 18, wherein the tablet or capsule has about 800 mg to 1,200 mg of composition.

20. The method of claim 15, which further comprises concurrently or subsequently administering at least one additional pharmaceutical composition comprising a sunscreen, a nutritional supplement or a topical application used to treat or protect the skin from damage from the exposure to skin damaging light.

21. The method of claim 20, wherein the additional pharmaceutical composition comprises:

a sunscreen having at least one of the following active ingredients;

titanium dioxide, zinc oxide, talc, red veterinary petrolatum, octyl methoxycinnamate, oxybenzone, octyl salicylate, or para-aminobenzoic acid;

a nutritional supplement having at least one of the following;

antioxidants, vitamin E, vitamin C, or carotenoids;

or

a topical application having at least one of the following;

vitamin A, vitamin E, vitamin C, or alpha-hydroxy acids.