# US 2019/0167567 A1 · Topical compositions and methods of using the same > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2019/0167567 A1 - Document ID: US20190167567A1 - Status: Published application - Kind: A1 - Application number: 16/267,738 - Filed: 2019-02-05 - Published: 2019-06-06 - Earliest claimed: 2013-02-28 - Assignees: Novan, Inc. - Applicants: Novan, Inc. - Inventors: Ryan Doxey; Adam Sabouni; Eleftherios Kougoulos; Nathan Stasko - Web page: https://patentgrep.com/patent/US20190167567A1 ## CPC - 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)} - A61K 9/06: Ointments; Bases therefor; {Other semi-solid forms, e.g. creams, sticks, gels (composition of ointments, creams or gels A61K47/00)} - A61K 33/00: Medicinal preparations containing inorganic active ingredients - A61K 47/10: Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers - A61K 47/12: Carboxylic acids; Salts or anhydrides thereof - A61K 47/32: Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers {, poly(meth)acrylates, or polyvinyl pyrrolidone} - A61K 47/6923: {the form being an inorganic particle, e.g. ceramic particles, silica particles, ferrite or synsorb} - A61P 17/00: Drugs for dermatological disorders - A61P 17/10: Anti-acne agents - A61P 31/04: Antibacterial agents - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) - A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS ## Abstract The present invention relates generally to compositions and methods of using the same. ## Claims ### Claim 1 A method of treating acne vulgaris, the method comprising topically applying to the skin of a subject a composition comprising: a first viscosity increasing agent; at least one polyhydric alcohol; at least one buffering agent; a second viscosity increasing agent; at least one organic solvent; at least one humectant; at least one water repellent; at least one active pharmaceutical ingredient; and water. ### Claim 2 (depends on 1) The method of claim 1, wherein the composition is buffered to a pH of about 3 to about 8. ### Claim 3 (depends on 1) The method of claim 1, wherein the at least one active pharmaceutical ingredient comprises a nitric oxide-releasing active pharmaceutical ingredient. ### Claim 4 (depends on 3) The method of claim 3, wherein the nitric oxide-releasing active pharmaceutical ingredient comprises a nitric oxide-releasing compound having a diazeniumdiolate functional group, optionally wherein the nitric oxide releasing compound comprises a NO-releasing co-condensed silica particle. ### Claim 5 (depends on 4) The method of claim 4, wherein the nitric oxide-releasing active pharmaceutical ingredient is present in the composition in an amount of about 0.5% to about 10% by weight of the composition. ### Claim 6 (depends on 4) The method of claim 4, wherein the composition stores and/or releases nitric oxide in an amount of about 0.05% to about 3% by weight of the composition. ### Claim 7 (depends on 6) The method of claim 6, wherein the one nitric oxide-releasing active pharmaceutical ingredient 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 composition to skin of a subject. ### Claim 8 (depends on 1) The method of claim 1, wherein the composition comprises a first composition in admixture with a second composition, the first composition comprising: the at least one polyhydric alcohol in an amount of about 1% to about 30% by weight of the first composition; the at least one 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; and water in an amount of about 70% to about 99% by weight of the first composition; and the second composition comprising: the second viscosity increasing agent in an amount of about 0.5% to about 30% by weight of the second composition; at least one organic solvent in an amount of about 50% to about 90 by weight of the second composition; at least one humectant in an amount of about 2% to about 20% by weight of the second composition; and the at least one water repellent in an amount of about 0.5% to about 15% by weight of the second composition. ### Claim 9 (depends on 1) The method of claim 1, wherein the composition is cosmetically elegant. ### Claim 10 (depends on 1) The method of claim 1, wherein the method reduces P. acnes counts on the skin of the subject. ### Claim 11 (depends on 10) The method of claim 10, wherein P. acnes counts are reduced by about 10% or greater over a defined period of time. ### Claim 12 (depends on 10) The method of claim 10, wherein the reduction in P. acnes counts is within 12 weeks or less. ### Claim 13 A composition in the form of a hydrogel, the hydrogel having a pH of about 3 to about 8 and is compatible with a second composition to form a structure in which an active pharmaceutical ingredient is suspended, upon combination of the hydrogel and the second composition, the hydrogel comprising: at least one polyhydric alcohol; at least one viscosity increasing agent; at least one buffering agent; and water. ### Claim 14 (depends on 13) The composition of claim 13, wherein the hydrogel comprises: the at least one polyhydric alcohol in an amount of about 1% to about 30% by weight of the hydrogel; the at least one viscosity increasing agent in an amount of about 0.1% to about 5% by weight of the hydrogel; the at least one buffering agent in an amount of about 0.01% to about 2% by weight of the hydrogel; and water in an amount of about 70% to about 99% by weight of the hydrogel; ### Claim 15 (depends on 13) The composition of claim 13, wherein, upon combination, the hydrogel and the second composition provide a combined composition having a pH in a range of about 6 to about 8. ### Claim 16 (depends on 13) The composition of claim 13, wherein, upon combination, the hydrogel and the second composition provide a combined composition that is cosmetically elegant. ### Claim 17 (depends on 13) The composition of claim 13, wherein the active pharmaceutical ingredient is a nitric oxide releasing active pharmaceutical ingredient and the hydrogel modulates the release of nitric oxide from the NO releasing active pharmaceutical ingredient. ### Claim 18 A method of treating acne vulgaris, the method comprising: providing an anhydrous topical gel comprising a nitric oxide-releasing active pharmaceutical ingredient; providing a hydrogel; combining the anhydrous topical gel comprising the nitric oxide-releasing active pharmaceutical ingredient and the hydrogel to provide a nitric oxide-releasing topical composition; and topically applying to the skin of a subject the nitric oxide-releasing topical composition. ### Claim 19 (depends on 18) The method of claim 18, wherein the nitric oxide-releasing topical composition is buffered to a pH of about 3 to about 8. ### Claim 20 (depends on 18) The method of claim 18, wherein the nitric oxide-releasing active pharmaceutical ingredient comprises a nitric oxide-releasing compound having a diazeniumdiolate functional group, optionally wherein the nitric oxide releasing compound comprises a NO-releasing co-condensed silica particle. ### Claim 21 (depends on 18) The method of claim 18, wherein the nitric oxide-releasing active pharmaceutical ingredient is present in the composition in an amount of about 0.5% to about 10% by weight of the composition. ### Claim 22 (depends on 18) The method of claim 18, wherein the nitric oxide-releasing topical composition stores and/or releases nitric oxide in an amount of about 0.05% to about 3% by weight of the composition. ### Claim 23 (depends on 18) The method of claim 18, wherein the nitric oxide-releasing active pharmaceutical ingredient 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 nitric oxide-releasing topical composition to skin of a subject.