Claims for Patent: 10,258,564

Summary for Patent: 10,258,564

Title:	Topical compositions and methods of using the same
Abstract:	The present invention relates generally to compositions and methods of using the same. A first aspect of the present invention comprises a composition comprising a first viscosity increasing agent; at least one polyhydric alcohol; at least one buffering agent; at least one preservative; a second viscosity increasing agent; at least one organic solvent; at least one humectant; at least one active pharmaceutical ingredient; and water, wherein the composition is buffered to a pH of about 3 to about 11.
Inventor(s):	Doxey Ryan, Sabouni Adam, Kougoulos Eleftherios, Stasko Nathan
Assignee:	Novan, Inc.
Application Number:	US14771138
Patent Claims:	1. A method of reducing inflammatory and/or noninflammatory lesions present on the skin of a subject , the method comprising:providing a first composition and a second composition that are separately stored;topically applying to the skin of the subject a composition comprising the first composition and the second composition, wherein the first composition and the second composition are combined prior to and/or during topical application of the combined composition to the skin of the subject,wherein the first composition comprises:a first viscosity increasing agent;at least one polyhydric alcohol;at least one buffering agent; andwater; andwherein the second composition comprises:a second viscosity increasing agent;at least one organic solvent;at least one humectant;at least one water repellent; anda nitric oxide-releasing compound having a diazeniumdiolate functional group, wherein the nitric oxide-releasing compound comprises a NO-releasing co-condensed silica particle,thereby reducing inflammatory and/or noninflammatory lesions present on the skin of the subject.2. The method of claim 1 , wherein the first composition has a pH of about.3. The method of claim 1 , wherein the nitric oxide-releasing compound is present in the combined composition in an amount of about 10% by weight of the combined composition or less.4. The method of claim 1 , wherein the combined composition stores and/or releases nitric oxide in an amount of about 0.05% to about 3% by weight of the combined composition.5. The method of claim 4 , wherein the nitric oxide-releasing compound releases nitric oxide in an amount of at least about 50% over a period of time of about 3 hours or less after topical application of the combined composition to skin of a subject.6. The method of claim 1 , wherein the first composition and the second composition are combined in a ratio of about 3:1 to about 0.2:1 of the first composition to the second composition claim 1 ,wherein the first composition comprises:the at least one polyhydric alcohol in an amount of about 1% to about 30% by weight of the first composition;the first viscosity increasing agent in an amount of about 0.1% to about 5% by weight of the first composition;the at least one buffering agent in an amount of about 0.01% to about 2% by weight of the first composition; andwater in an amount of about 70% to about 99% by weight of the first composition; andwherein the second composition comprises:the second viscosity increasing agent in an amount of about 0.5% to about 30% by weight of the second composition;the at least one organic solvent in an amount of about 50% to about 90 by weight of the second composition;the at least one humectant in an amount of about 2% to about 20% by weight of the second composition; andthe at least one water repellent in an amount of about 0.5% to about 15% by weight of the second composition.7. The method of claim 1 , wherein the combined composition is cosmetically elegant.8. The method of claim 1 , wherein the number of inflammatory and/or noninflammatory lesions is reduced by about 10% or greater over a defined period of time.9. The method of claim 1 , wherein the reduction in inflammatory and/or noninflammatory lesions is within 12 weeks or less.10. The method of claim 1 , wherein the method reduces noninflammatory lesions on the skin of the subject.11. The method of claim 1 , wherein the method reduces inflammatory lesions on the skin of the subject.12. The method of claim 1 , wherein the method reduces inflammatory and noninflammatory lesions on the skin of the subject.13. The method of claim 1 , wherein the first viscosity increasing agent is selected from the group consisting of a carboxypolymethylene claim 1 , a polyacrylic polymer claim 1 , a cellulose ether claim 1 , a methacrylate claim 1 , a polyvinylpyrollidone claim 1 , a polyvinylalcohol claim 1 , a polyethylene oxide claim 1 , a polyethylene glycol claim 1 , a polyvinylalkyl ether-maleic acid copolymer claim 1 , a carboxy vinyl polymer claim 1 , a polysaccharide claim 1 , a gum claim 1 , a protein claim 1 , a starch claim 1 , bentonite claim 1 , calcium stearate claim 1 , ceratonia claim 1 , colloidal silicon dioxide claim 1 , dextrin claim 1 , hypromellose claim 1 , polycarbophil claim 1 , kaolin claim 1 , saponite claim 1 , sorbitan esters claim 1 , sucrose claim 1 , sesame oil claim 1 , tragacanth claim 1 , potassium alginate claim 1 , povidone claim 1 , sodium starch glycolate claim 1 , phospholipids claim 1 , and any combination thereof.14. The method of claim 1 , wherein the at least one buffering agent is selected from the group consisting of citric acid claim 1 , acetic acid claim 1 , lactic acid claim 1 , boric acid claim 1 , succinic acid claim 1 , malic acid claim 1 , and any combination thereof.15. The method of claim 1 , wherein the second composition comprises the nitric oxide-releasing compound in an amount of 0.01% to 50% by weight of the second composition.16. The method of claim 1 , wherein the second composition comprises the nitric oxide-releasing compound in an amount of 0.01% to 30% by weight of the second composition.17. The method of claim 1 , wherein the second composition comprises the nitric oxide-releasing compound in an amount of 0.01% to 20% by weight of the second composition.18. The method of claim 1 , wherein the second composition comprises the nitric oxide-releasing compound in an amount of 0.01% to 10% by weight of the second composition.19. The method of claim 1 , wherein the first composition is a hydrogel.