# US 2025/0144084 A1 · Pharmaceutical compositions of roflumilast and solvents capable of dissolving high amounts of the drug > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2025/0144084 A1 - Document ID: US20250144084A1 - Status: Published application - Kind: A1 - Application number: 18/942,389 - Filed: 2024-11-09 - Published: 2025-05-08 - Earliest claimed: 2022-09-15 - Assignees: Arcutis Biotherapeutics, Inc. - Applicants: Arcutis Biotherapeutics, Inc. - Inventors: David W. OSBORNE; Babak N. TOFIG; Frank WATANABE - Web page: https://patentgrep.com/patent/US20250144084A1 ## CPC - A61K 31/44: Non condensed pyridines; Hydrogenated derivatives thereof - 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 47/10: Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers - A61K 47/14: Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters - A61K 47/22: Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones - 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) ## Abstract Topical pharmaceutical compositions comprising roflumilast and solvents that are capable of dissolving high amounts of roflumilast. The pharmaceutical compositions are capable of dissolving high amounts of roflumilast relative to other commonly used solvents in approved topical pharmaceutical compositions. The solvents are particularly useful when combined with water to maintain high levels of dissolved roflumilast, which is highly insoluble in water. ## Claims ### Claim 1 A method of treating a patient suffering from an inflammatory or allergic dermatosis, the method comprising topically applying to the patient a pharmaceutical composition comprising a pharmaceutically effective amount of roflumilast, water, and a pharmaceutically acceptable solvent selected from the group consisting of 1,3-butylene glycol, 1,2-hexanediol, 1,3-propanediol, 1,2-pentanediol, dipropylene glycol, 2-(2-butoxy-ethoxy)ethanol, 1,6-hexanediol, propylene glycol methyl ethyl acetate, 5-methyloxolan-2-one, pantolactone, and combinations thereof. ### Claim 2 (depends on 1) The method of claim 1, wherein said roflumilast is present in an amount of about 0.005% to about 2% w/w. ### Claim 3 (depends on 2) The method of claim 2, wherein the inflammatory dermatosis is psoriasis. ### Claim 4 (depends on 2) The method of claim 2, wherein the inflammatory dermatosis is eczema. ### Claim 5 (depends on 2) The method of claim 2, wherein the inflammatory dermatosis is atopic dermatitis. ### Claim 6 (depends on 2) The method of claim 2, wherein the inflammatory dermatosis is seborrheic dermatitis. ### Claim 7 (depends on 2) The method of claim 2, wherein said solvent and water are present in an approximately equal molar blend. ### Claim 8 (depends on 2) The method of claim 2, wherein said solvent and water are present in an approximately 1:2 solvent to water blend (weight:weight). ### Claim 9 (depends on 3) The method of claim 3, wherein said pharmaceutical composition is selected from the group consisting of an emulsion, a gel, and an ointment. ### Claim 10 (depends on 9) The method of claim 9, wherein said pharmaceutical composition further comprises at least one additional component selected from the group consisting of a moisturizer, a surfactant or emulsifier, a polymer or thickener, an antifoaming agent, a preservative, an antioxidant, a sequestering agent, a stabilizer, a buffer, a pH adjusting agent, a skin penetration enhancer, a film former, a dye, a pigment, and a fragrance. ### Claim 11 (depends on 3) The method of claim 3, wherein the solvent comprises 1,3-butylene glycol. ### Claim 12 (depends on 3) The method of claim 3, wherein the solvent comprises 1,2-hexanediol. ### Claim 13 (depends on 3) The method of claim 3, wherein the solvent comprises 1,3-propanediol. ### Claim 14 (depends on 3) The method of claim 3, wherein the solvent comprises 1,2-pentanediol. ### Claim 15 (depends on 3) The method of claim 3, wherein the solvent comprises dipropylene glycol. ### Claim 16 (depends on 3) The method of claim 3, wherein the solvent comprises 2-(2-butoxy-ethoxy)ethanol. ### Claim 17 (depends on 3) The method of claim 3, wherein the solvent comprises 1,6-hexanediol. ### Claim 18 (depends on 3) The method of claim 3, wherein the solvent comprises propylene glycol methyl ethyl acetate. ### Claim 19 (depends on 3) The method of claim 3, wherein the solvent comprises 5-methyloxolan-2-one. ### Claim 20 (depends on 3) The method of claim 3, wherein the solvent comprises pantolactone.