Methods and compositions for treatment of dermal conditions

• US 20040096410A1
• Filed: 07/29/2003
• Published: 05/20/2004
• Est. Priority Date: 07/29/2002
• Status: Active Grant

• Current Assignee: Avent Incorporated (Avanos Medical, Inc.)
• Original Assignee: Kimberly-Clark Worldwide Incorporated (Kimberly-Clark Corporation)
• Inventors: Gibbins, Bruce L., Maley, Joseph C.
• Granted Patent: US 8,486,426 B2
• Time in Patent Office: Days
• US Class Current: 424/70.1
• CPC Class Codes: A61F 13/105 for the fingers; Finger-stalls; Nail-protectors devices for correcting deformities of the nails A61F5/11
• CPC Class Codes: A61K 31/00 Medicinal preparations containing organic active ingredients
• CPC Class Codes: A61K 31/10 Sulfides; Sulfoxides; Sulfones
• CPC Class Codes: A61K 31/17 having the group >N—C(O)—N< or >N—C(S)—N<, e.g. urea, thiourea, carmustine isoureas, isothioureas A61K31/155; sulfonylureas A61K31/64
• CPC Class Codes: A61K 31/201 having one or two double bonds, e.g. oleic, linoleic acids
• CPC Class Codes: A61K 31/395 having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
• CPC Class Codes: A61K 31/60 Salicylic acid; Derivatives thereof
• CPC Class Codes: A61K 47/32 Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers , poly(meth)acrylates, or polyvinyl pyrrolidone
• 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 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: A61K 9/7007 Drug-containing films, membranes or sheets A61K9/0041, A61K9/0043, A61K9/006, A61K9/0063 take precedence
• CPC Class Codes: A61P 17/00 Drugs for dermatological disorders
• CPC Class Codes: A61P 31/10 Antimycotics

Abstract

The present invention comprises methods and compositions for the treatment of pathological conditions of the dermis and dermal structures of animals and humans. In particular, the present invention comprises the use of topical delivery vehicles, including hydrogels, which incorporate active agents such as organic acids, for the treatment of dermal conditions.

Claims

1. A method of treating a dermal condition comprising,

a) applying a composition comprising at least one active agent to a site of a dermal condition,

b) maintaining the composition at the site for a sufficient amount of time so that an effective amount of the active agent is delivered.

2. The method of claim 1 wherein the at least one active agent comprises an organic acid.

3. The method of claim 2 wherein the organic acid comprises citric acid.

4. The method of claim 3 wherein the citric acid is in a concentration between 0.1 and 16%, preferably between 4 and more preferably between 6 and 12%.

5. The method of claim 1, wherein the composition further comprises a matrix, at least one humectant, and an effective amount of moisture so that a diffusion gradient is established between the composition and the dermal structure once the composition is applied.

6. The method of claim 5, wherein the matrix is made of natural or synthetic hydrophilic polymers, rubber, collagen, animal hide, hyaluronic acid, dextran, alginates, cellulose, carboxymethycellulose, hydroxymethycellulose, elastomers, polyethylenes, polypropylenes, polybutyrate, polyacrylate, polyacrylamide, polybuterate, polyurethane foam, silicone elastomer, nylon, vinyl or cross linked dextran.

7. The method of claim 5 wherein the humectant is glycerol.

8. The method of claim 1, wherein the composition further comprises at least one attachment element.

9. The method of claim 1, wherein the composition is an amorphous hydrogel.

10. The method of claim 1, wherein the composition is a cream, salve, lotion, or emulsion.

11. A composition comprising,

a) a matrix material;

b) at least one active agent;

c) humectant; and

d) moisture content effective to create a diffusion gradient when the composition is placed on a dermal structure.

12. The composition of claim 11, further comprising a moisture management system.

13. The composition of claim 11, further comprising at least one attachment element.

14. The composition of claim 11, wherein the matrix material comprises natural or synthetic hydrophilic polymers, rubber, collagen, animal hide, hyaluronic acid, dextran, alginates, cellulose, carboxymethycellulose, hydroxymethycellulose, elastomers, polyethylenes, polypropylenes, polybutyrate, polyacrylate, polyacrylamide, polybuterate, polyurethane foam, silicone elastomer, nylon, vinyl or cross linked dextran.

15. The composition of claim 11, wherein the at least one active agent is chosen from a group consisting of citric acid, sorbic acid, ascorbic acid, salicilic acid, tannic acid, succinic acid, lactic acid, pyruvic acid, alpha ketoglutaric acid, glutamic acid, acetic acid, butaric acid, salicylic acid iodine, DMSO, azole derivatives, undecylenic acid, tea tree oil, urea, selenium sulfide, resorcinol, ketoconazole, Clotrimazole, Terbinafine, Ciclopirox olamine, Diflucan, anti-yeast compounds, antibacterial compounds, and antiviral compounds.

16. The composition of claim 11, wherein the humectant is chosen from the group consisting of an organic alcohol, glycerol, butanol, propanol, isopropyl alcohol, ethanol, methanol, propylene glycol, polyethylene glycol, ethylene alcohol, butyl alcohol, sodium chloride, lithium chloride, copper chloride, magnesium chloride, magnesium sulfate, manganese sulphate, aluminum sulfate, zinc sulfate, or zinc chloride.

17. The composition of claim 11, wherein the moisture content of the composition is a range of from 0.1% to 50% water.

18. A composition for treatment of dermal structures, comprising,

a) a cross-linked polyacrylamide matrix, a non-gellable polysaccharide, citric acid, and water.

19. The composition of claim 18, wherein the citric acid is in a concentration of 8% to 16% w/w.

20. The composition of claim 18, wherein the water content is from 0.1%to50%.