COMPOSITIONS AND METHODS TO AFFECT SKIN IRRITATION

• US 20170182086A1
• Filed: 12/21/2016
• Published: 06/29/2017
• Est. Priority Date: 12/28/2015
• Status: Active Grant

• Current Assignee: Alumend LLC, WavePharma LLC
• Original Assignee: Alumend LLC
• Inventors: Utecht, Ronald E., Downey, Therese M.
• Granted Patent: US 9,833,469 B2
• Time in Patent Office: Days
• CPC Class Codes: A61F 13/8405 Additives, e.g. for odour, disinfectant or pH control
• 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 2800/75 Anti-irritant
• CPC Class Codes: A61K 2800/782 Enzyme inhibitors; Enzyme antagonists
• CPC Class Codes: A61K 31/05 Phenols cannabinoids A61K31/658
• CPC Class Codes: A61K 31/07 Retinol compounds, e.g. vitamin A retinoic acids A61K31/203
• CPC Class Codes: A61K 31/185 Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids hydroxamic acids A61K31/16; peroxy acids A61K31/327
• CPC Class Codes: A61K 31/203 Retinoic acids ; Salts thereof
• CPC Class Codes: A61K 31/722 Chitin, chitosan
• CPC Class Codes: A61K 31/737 Sulfated polysaccharides, e.g. chondroitin sulfate, dermatan sulfate A61K31/727 takes precedence
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61K 47/36 Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
• CPC Class Codes: A61K 8/347 Phenols
• 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 8/736 Chitin; Chitosan; Derivatives thereof
• CPC Class Codes: A61K 9/0014 Skin, i.e. galenical aspects of topical compositions non-active ingredients are additionally classified in A61K47/00; A61K9/0009, A61K9/0021, A61K9/7015, A61K9/7023 take precedence; cosmetic preparations A61K8/00, A61Q; preparations for wound dressings or bandages A61L26/00
• CPC Class Codes: A61P 17/18 Antioxidants, e.g. antiradicals preparations for protection against sunlight A61Q17/00
• CPC Class Codes: A61Q 19/08 Anti-ageing preparations

Abstract

Compositions are described that contain treated chitosan, modified chitosan and/or modified and treated chitosan for use in formulations for skin, hair and nails, and in compositions and methods of reducing topical agent-induced skin irritation and inflammation.

Claims

1. A composition comprising:

(a) at least one topical irritating agent, and

(b) at least one treated chitosan modified chitosan, modified and treated chitosan, or a mixture or combination thereof, in a non-particulate form, wherein the modified chitosan comprises one or more charged groups, lipophilic groups, hydrophilic groups, cationic groups or non-polymeric anionic groups covalently bound to chitosan, and the treated chitosan comprises one or more charged groups, lipophilic groups, hydrophilic groups, cationic groups or non-polymeric anionic groups ionically bound to chitosan or bound to chitosan via hydrogen bonds, and

wherein the composition provides a reduction in skin irritation and/or a reduction in skin inflammation and/or a reduction in irritant-induced IL-1α

secretion after contact with the composition compared with a control composition comprising the topical irritating agent but not the chitosan.

2. The composition of claim 1, wherein said at least one topical irritating agent comprises cosmetic agents, therapeutic agents, cleansing agents, detergents, disinfectants, antiseptics, antimicrobial agents, anti-fungal agents, anti-parasitic agents, anti-bacterial agents, anti-viral agents, insecticides, analgesics, anti-aging agents, skin protectants, sunscreens, deodorants, antiperspirants, depilatory agents, shaving agents, after-shaving agents, hair growth agents, dandruff control agents, solvents, fragrances, dyes, adhesives, paint removers, nail-polish remover, preservatives, sterilizing agents, transdermal-delivery agents, transdermal delivery devices, acids, bases, minerals, or their compositions or combinations thereof.

3. The composition of claim 2, wherein said cosmetic or therapeutic agents comprise anti-aging agents, lightening agents, darkening agents, beautifying agents, retinoids, retinoid derivatives, retinoid precursors, retinoid active metabolites, chemical peels, anti-oxidants, botanical extracts, marine-based extracts, acne therapeutic agents, rosacea therapeutic agents, actinic keratosis therapeutic agents, anti-inflammatory agents, anti-bacterial agents, anti-fungal agents, anti-viral agents, anti-parasitic agents, anti-wart agents, or their compositions or combinations thereof.

4. The composition of claim 3, wherein said retinoids, retinoid precursors or retinoid derivatives comprise retinol, retinal, retinyl esters, tretinoin, retinoic acid, Vitamin A, esters of Vitamin A, isotretinoin, alitretinoin, etretinate, acitretin, adapalene, bexarotene, tazarotene, retinol-palmitate, compounds that will generate the active retinoid or its active metabolites on the skin by either enzymatic or non-enzymatic reactions, chemically modified versions thereof, or combinations thereof.

5. The composition of claim 3, wherein said retinoids, retinoid precursors or retinoid derivatives comprise about 0.001-5% W/V of the total weight of the composition.

6. The composition of claim 1, wherein said lipophilic group is an alkyl group and said non-polymeric anion is selected from the group consisting of phosphate, citrate, pyro-phosphate, sulfate, iodide, bromide, chloride, nitrate, nitrite, oxalate, acetate, fluoride, chlorate, bromate, chlorite, formate, hydrogen phosphate, and dihydrogen phosphate.

7. The composition of claim 6, wherein said alkyl modified chitosan is covalently modified with an alkyl sulfonic acid.

8. The composition of claim 7, wherein said alkyl sulfonic acid is octane sulfonic acid.

9. The composition of claim 1, wherein said at least one treated chitosan modified chitosan, modified and treated chitosan, or a mixture or combination thereof comprises about 0.0001-5% W/V of the total weight of the composition.

10. A method for reducing skin irritation and/or reducing skin inflammation and/or reducing irritant-induced IL-1α

secretion induced by a topical agent comprising topically applying a composition comprising;

(a) an amount of at least one topical irritating agent, and

(b) an amount of at least one treated chitosan, modified chitosan, modified and treated chitosan, or a mixture or combination thereof in a non-particulate form, effective to reduce, and/or to ameliorate the topical agent-induced irritation and/or inflammation and/or IL-1α

secretion, wherein the modified chitosan comprises one or more charged groups, lipophilic groups, hydrophilic groups, cationic groups or non-polymeric anionic groups covalently bound to chitosan, and the treated chitosan comprises one or more charged groups, lipophilic groups, hydrophilic groups, cationic groups or non-polymeric anionic groups ionically bound to chitosan or bound to chitosan via hydrogen bonds.

11. The method of claim 10, wherein said at least one topical irritating agent comprises cosmetic agents, therapeutic agents, cleansing agents, detergents, disinfectants, antiseptics, antimicrobial agents, anti-fungal agents, anti-parasitic agents, anti-bacterial agents, anti-viral agents, insecticides, analgesics, anti-aging agents, skin protectants, sunscreens, deodorants, antiperspirants, depilatory agents, shaving agents, after-shaving agents, hair growth agents, dandruff control agents, solvents, fragrances, dyes, adhesives, paint removers, nail-polish remover, preservatives, sterilizing agents, transdermal-delivery agents, transdermal delivery devices, acids, bases, minerals, or their compositions or combinations thereof.

12. The method of claim 11, wherein said cosmetic or therapeutic agents comprise anti-aging agents, lightening agents, darkening agents, beautifying agents, retinoids, retinoid derivatives, retinoid precursors, retinoids active metabolites, chemical peels, anti-oxidants, botanical extracts, marine-based extracts, acne therapeutic agents, rosacea therapeutic agents, psoriasis therapeutic agents, actinic keratosis therapeutic agents, anti-inflammatory agents, anti-bacterial agents, anti-fungal agents, anti-viral agents, anti-parasitic agents, anti-wart agents, or their compositions or combinations thereof.

13. The method of claim 12, wherein said retinoids, retinoid precursors or derivatives of retinoids comprise retinol, retinal, retinyl esters, tretinoin, retinoic acid, Vitamin A, esters of Vitamin A, isotretinoin, alitretinoin, etretinate, acitretin, adapalene, bexarotene, tazarotene, retinol-palmitate, compounds that will generate the active retinoid or its active metabolites on the skin by either enzymatic or non-enzymatic reactions, chemically modified versions thereof, or combinations thereof.

14. The method of claim 12, wherein said retinoids, retinoid precursors or retinoid derivatives comprise about 0.001-5% W/V of the total weight of the composition.

15. The method of claim 10, wherein said lipophilic group is an alkyl group and said non-polymeric anion is selected from the group consisting of phosphate, citrate, pyro-phosphate, sulfate, iodide, bromide, chloride, nitrate, nitrite, oxalate, acetate, fluoride, chlorate, bromate, chlorite, formate, hydrogen phosphate, and dihydrogen phosphate.

16. The method of claim 15, wherein said alkyl modified chitosan is covalently modified with an alkyl sulfonic acid.

17. The method of claim 16, wherein said alkyl sulfonic acid is octane sulfonic acid.

18. The method of claim 10, wherein said at least one treated chitosan modified chitosan, modified and treated chitosan, or a mixture or combination thereof comprises about 0.0001-5% W/V of the total weight of the composition.

19. A method for reducing skin irritation and/or reducing skin inflammation and/or reducing irritant-induced IL-1α

secretion induced by a contact with an exogenous agent comprising applying a topical composition comprising an amount of at least one treated chitosan modified chitosan, modified and treated chitosan, or a mixture or combination thereof in a non-particulate form, effective to reduce, and/or to ameliorate the exogenous agent-induced skin irritation and/or inflammation and/or IL-1α

secretion, wherein the modified chitosan comprises one or more charged groups, lipophilic groups, hydrophilic groups, cationic groups or non-polymeric anionic groups covalently bound to chitosan, and the treated chitosan comprises one or more charged groups, lipophilic groups, hydrophilic groups, cationic groups or non-polymeric anionic groups ionically bound to chitosan or bound to chitosan via hydrogen bonds.

20. The method of claim 19, wherein said applying is before or after contact with the exogenous agent.

21. The method of claim 20, wherein said exogenous agent comprises botanicals, plant parts, plant extracts, irritants of botanical origin, irritants of marine origin, irritants of fungal origin, irritants of microbial origin, irritants of parasitic origin, chemicals, minerals, metals, contact-dermatitis-inducing agents, foods, urine irritants, fecal irritants, detergents, cosmetic agents, therapeutic agents, cleansing agents, detergents, disinfectants, antiseptics, antimicrobial agents, anti-fungal agents, anti-viral agents, anti-parasitic agents, anti-bacterial agents, insecticides, analgesics, anti-aging agents, skin protectants, sunscreens, deodorants, antiperspirants, depilatory agents, shaving agents, after-shaving agents, hair growth agents, dandruff control agents, solvents, fragrances, adhesives, dyes, paint removers, nail-polish remover, preservatives, sterilizing agents, UV irradiation, transdermal-delivery agents, transdermal delivery devices, acids, bases, minerals, or their compositions or combinations thereof.

22. The method of claim 21, wherein said plant parts or plant extracts comprise plants that cause a contact or allergic dermatitis, poison ivy, poison oak, or poison sumac.

23. The method of claim 21, wherein said urine irritants or fecal irritants cause diaper rash.

24. The method of claim 21, wherein said metals are metals used in jewelry comprising nickel.

25. The method of claim 21, wherein said cosmetic or therapeutic agents comprises anti-aging agents, lightening agents, darkening agents, beautifying agents, retinoids, retinoid derivatives, retinoid precursors, retinoids active metabolites, chemical peels, anti-oxidants, botanical extracts, marine-based extracts, acne therapeutic agents, rosacea therapeutic agents, psoriasis therapeutic agents, actinic keratosis therapeutic agents, anti-inflammatory agents, anti-bacterial agents, anti-fungal agents, anti-viral agents, anti-parasitic agents, or their compositions or combinations thereof.

26. The method of claim 19, wherein said lipophilic group is an alkyl group and said non-polymeric anion is selected from the group consisting of phosphate, citrate, pyro-phosphate, sulfate, iodide, bromide, chloride, nitrate, nitrite, oxalate, acetate, fluoride, chlorate, bromate, chlorite, formate, hydrogen phosphate, and dihydrogen phosphate.

27. The method of claim 26, wherein said alkyl modified chitosan is covalently modified with an alkyl sulfonic acid.

28. The method of claim 27, wherein said alkyl sulfonic acid is octane sulfonic acid.

29. The method of claim 19, wherein said at least one treated chitosan modified chitosan, modified and treated chitosan, or a mixture or combination thereof comprises about 0.0001-5% W/V of the total weight of the composition.