# US 8,784,780 B2 · High oil-content emollient aerosol foam compositions > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 8,784,780 B2 - Document ID: US8784780B2 - Status: Granted - Kind: B2 - Application number: 13/046,088 - Filed: 2011-03-11 - Published: 2011-12-15 - Granted: 2014-07-22 - Earliest claimed: 2010-06-11 - Assignees: Precision Dermatology, Inc. - Applicants: Ronald M. Gurge; Mark W. Trumbore; Lisa Chin; Poonam S. Hirani - Inventors: Ronald M. Gurge; Mark W. Trumbore; Lisa Chin; Poonam S. Hirani - Web page: https://patentgrep.com/patent/US8784780B2 ## CPC - A61K 9/12: Aerosols; Foams {(A61K9/0043, A61K9/0056, A61K9/006, A61K9/0073 take precedence; spray-films A61K9/7015)} - 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 9/107: Emulsions {; Emulsion preconcentrates; Micelles (composition of emulsions A61K47/00)} - A61K 9/122: {Foams; Dry foams (edible foams A61K9/0056)} - A61P 3/02: Nutrients, e.g. vitamins, minerals - A61P 7/06: Antianaemics - A61P 7/10: Antioedematous agents; Diuretics - A61P 17/00: Drugs for dermatological disorders - A61P 17/02: for treating wounds, ulcers, burns, scars, keloids, or the like - A61P 17/06: Antipsoriatics - A61P 17/08: Antiseborrheics - A61P 17/10: Anti-acne agents - A61P 29/00: Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID] - A61P 31/10: Antimycotics - A61P 37/02: Immunomodulators - A61P 37/08: Antiallergic agents (antiasthmatic agents A61P11/06; ophthalmic antiallergics A61P27/14) - 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 Described herein are high oil-content emulsions and compositions for the treatment of inflammatory skin disorders. The emulsions may be formulated as aerosol compositions. The aerosol propellant may be a hydrofluoroalkane propellant. The emulsions or compositions may comprise active agents, such as corticosteroids. Also described are methods of treating inflammatory skin disorders, comprising the step of applying to an affected area of a subject in need thereof a therapeutically-effective amount of an inventive emulsion or aerosol composition. ## Claims ### Claim 1 A method of treating an inflammatory skin disorder, comprising the step of applying to an affected area of a subject in need thereof a therapeutically-effective amount of a composition comprising: an emulsion, wherein the emulsion comprises Ceteth-20, from about 1% to about 5% by weight of the emulsion; cetostearyl alcohol, from about 3% to about 9% by weight of the emulsion; mineral oil, from about 1% to about 18% by weight of the emulsion; petrolatum, from about 3% to about 11% by weight of the emulsion; dimethicone, from about 0.5% to about 2.0% by weight of the emulsion; butylated hydroxytoluene, from about 0.01% to about 0.05% by weight of the emulsion; water, from about 27% to about 82% by weight of the emulsion; glycerin, from about 2.5% to about 7.5% by weight of the emulsion; urea, from about 0.3% to about 0.9% by weight of the emulsion; citric acid, from about 0.2% to about 0.6% by weight of the emulsion; sodium citrate, from about 0.1% to about 0.5% by weight of the emulsion; methylparaben, from about 0.1% to about 0.5% by weight of the emulsion; propylparaben, from about 0.05% to about 0.20% by weight of the emulsion; and an active agent, from about 0.002% to about 0.20% by weight of the emulsion; a propellant; and a purge gas. ### Claim 2 (depends on 1) The method of claim 1, wherein the inflammatory skin disorder is selected from the group consisting of psoriasis, atopic dermatitis, contact dermatitis, xerotic eczema, seborrheic dermatitis, discoid eczema, venous eczema, acne, rosacea, poison ivy, hives, and occupational dermatitis. ### Claim 3 (depends on 2) The method of claim 2, wherein the subject is human. ### Claim 4 (depends on 3) The method of claim 3, wherein the affected area of the subject is the face, earlobes, neck, scalp, genitals, eyelids, palms, fingers, feet, exural surfaces of joints, or extensor aspects of joints. ### Claim 5 (depends on 4) The method of claim 4, wherein the composition is applied once daily or twice daily. ### Claim 6 (depends on 1) The method of claim 1, wherein the active agent is selected from the group consisting of corticosteroids, vitamin D analogues, retinoids, immunomodulators, antifungals, and combinations/mixtures thereof. ### Claim 7 (depends on 1) The method of claim 1, wherein the active agent is selected from the group consisting of hydrocortisone, hydroxyl-triamcinolone, alpha-methyl dexamethasone, dexamethasone-phosphate, beclomethasone dipropionates, clobetasol valerate, desonide, desoxymethasone, desoxycorticosterone acetate, dexamethasone, dichlorisone, diflorasone diacetate, diflucortolone valerate, fluadrenolone, fluclorolone acetonide, fludrocortisone, flumethasone pivalate, fluosinolone acetonide, fluocinonide, flucortine butylesters, fluocortolone, fluprednidene acetate, flurandrenolone, halcinonide, hydrocortisone acetate, hydrocortisone butyrate, methylprednisolone, triamcinolone acetonide, cortisone, cortodoxone, flucetonide, fludrocortisone, difluorosone diacetate, fluradrenolone, fludrocortisone, difluorosone diacetate, fluradrenolone acetonide, medrysone, amcinafel, amcinafide, betamethasone dipropionate, chloroprednisone, chlorprednisone acetate, clocortelone, clescinolone, dichlorisone, diflurprednate, flucloronide, flunisolide, fluoromethalone, fluperolone, fluprednisolone, hydrocortisone valerate, hydrocortisone cyclopentylpropionate, hydrocortamate, meprednisone, paramethasone, prednisolone, prednisone, beclomethasone dipropionate, triamcinolone, and combinations/mixtures thereof. ### Claim 8 (depends on 1) The method of claim 1, wherein the active agent is selected from the group consisting of hydrocortisone butyrate, betamethasone dipropionate, and combinations/mixtures thereof. ### Claim 9 (depends on 1) The method of claim 1, wherein the active agent is selected from the group consisting of vitamin A, vitamin D, vitamin E, vitamin K, vitamin D analogue calcipotriene, vitamin D analogue calcipotriol, and combinations/mixtures thereof. ### Claim 10 (depends on 1) The method of claim 1, wherein the active agent is selected from the group consisting of retinoids, retinoic acid, tretinoin, and combinations/mixtures thereof. ### Claim 11 (depends on 1) The method of claim 1, wherein the emulsion comprises: Ceteth-20, in about 3.00% by weight of the emulsion; cetostearyl alcohol, in about 6.00% by weight of the emulsion; mineral oil, in about 12.38% by weight of the emulsion; petrolatum, in about 7.50% by weight of the emulsion; dimethicone, in about 1.00% by weight of the emulsion; butylated hydroxytoluene, in about 0.03% by weight of the emulsion; water, in about 54.46% by weight of the emulsion; glycerin, in about 5.00% by weight of the emulsion; urea, in about 0.64% by weight of the emulsion; citric acid, in about 0.42% by weight of the emulsion; sodium citrate, in about 0.32% by weight of the emulsion; methylparaben, in about 0.30% by weight of the emulsion; propylparaben, in about 0.10% by weight of the emulsion; and hydrocortisone butyrate, in about 0.10% by weight of the emulsion; and the emulsion further comprises safflower oil, in about 6.75% by weight of the emulsion. ### Claim 12 (depends on 1) The method of claim 1, wherein the emulsion comprises Ceteth-20, in about 3.00% by weight of the emulsion; cetostearyl alcohol, in about 6.00% by weight of the emulsion; mineral oil, in about 12.38% by weight of the emulsion; petrolatum, in about 7.50% by weight of the emulsion; dimethicone, in about 1.00% by weight of the emulsion; butylated hydroxytoluene, in about 0.03% by weight of the emulsion; water, in about 55.46% by weight of the emulsion; glycerin, in about 5.00% by weight of the emulsion; urea, in about 0.64% by weight of the emulsion; citric acid, in about 0.42% by weight of the emulsion; sodium citrate, in about 0.32% by weight of the emulsion; methylparaben, in about 0.30% by weight of the emulsion; propylparaben, in about 0.10% by weight of the emulsion; and hydrocortisone butyrate, in about 0.10% by weight of the emulsion; and the emulsion further comprises safflower oil, in about 6.75% by weight of the emulsion; oleic acid, in about 0.50% by weight of the emulsion; and stearic acid, in about 0.50% by weight of the emulsion. ### Claim 13 (depends on 1) The method of claim 1, wherein the emulsion comprises: Ceteth-20, in about 3.00% by weight of the emulsion; cetostearyl alcohol, in about 6.00% by weight of the emulsion; mineral oil, in about 12.38% by weight of the emulsion; petrolatum, in about 7.50% by weight of the emulsion; dimethicone, in about 1.00% by weight of the emulsion; butylated hydroxytoluene, in about 0.03% by weight of the emulsion; water, in about 56.51% by weight of the emulsion; glycerin, in about 5.00% by weight of the emulsion; urea, in about 0.64% by weight of the emulsion; citric acid, in about 0.42% by weight of the emulsion; sodium citrate, in about 0.32% by weight of the emulsion; methylparaben, in about 0.30% by weight of the emulsion; propylparaben, in about 0.10% by weight of the emulsion; and betamethasone dipropionate, in about 0.05% by weight of the emulsion; and the emulsion further comprises safflower oil, in about 6.75% by weight of the emulsion. ### Claim 14 (depends on 1) The method of claim 1, wherein the emulsion comprises: Ceteth-20, in about 3.00% by weight of the emulsion; cetostearyl alcohol, in about 6.00% by weight of the emulsion; mineral oil, in about 2.38% by weight of the emulsion; petrolatum, in about 6.85% by weight of the emulsion; dimethicone, in about 1.00% by weight of the emulsion; butylated hydroxytoluene, in about 0.03% by weight of the emulsion; water, in about 56.51% by weight of the emulsion; glycerin, in about 5.00% by weight of the emulsion; urea, in about 0.64% by weight of the emulsion; citric acid, in about 0.42% by weight of the emulsion; sodium citrate, in about 0.32% by weight of the emulsion; methylparaben, in about 0.30% by weight of the emulsion; propylparaben, in about 0.10% by weight of the emulsion; and betamethasone dipropionate, in about 0.05% by weight of the emulsion; and the emulsion further comprises oleic acid, in about 7.40% by weight of the emulsion; and oleyl alcohol, in about 10.00% by weight of the emulsion. ### Claim 15 (depends on 1) The method of claim 1, wherein the emulsion comprises: Ceteth-20, in about 3.00% by weight of the emulsion; cetostearyl alcohol, in about 6.00% by weight of the emulsion; mineral oil, in about 12.38% by weight of the emulsion; petrolatum, in about 7.50% by weight of the emulsion; dimethicone, in about 1.00% by weight of the emulsion; butylated hydroxytoluene, in about 0.03% by weight of the emulsion; water, in about 56.54% by weight of the emulsion; glycerin, in about 5.00% by weight of the emulsion; urea, in about 0.64% by weight of the emulsion; citric acid, in about 0.42% by weight of the emulsion; sodium citrate, in about 0.32% by weight of the emulsion; methylparaben, in about 0.30% by weight of the emulsion; propylparaben, in about 0.10% by weight of the emulsion; and tretinoin, in about 0.02% by weight of the emulsion; and the emulsion further comprises safflower oil, in about 6.75% by weight of the emulsion. ### Claim 16 (depends on 1) The method of claim 1, wherein the emulsion comprises: Ceteth-20, in about 3.00% by weight of the emulsion; cetostearyl alcohol, in about 6.00% by weight of the emulsion; mineral oil, in about 12.38% by weight of the emulsion; petrolatum, in about 7.50% by weight of the emulsion; dimethicone, in about 1.00% by weight of the emulsion; butylated hydroxytoluene, in about 0.03% by weight of the emulsion; water, in about 56.555% by weight of the emulsion; glycerin, in about 5.00% by weight of the emulsion; urea, in about 0.64% by weight of the emulsion; citric acid, in about 0.42% by weight of the emulsion; sodium citrate, in about 0.32% by weight of the emulsion; methylparaben, in about 0.30% by weight of the emulsion; propylparaben, in about 0.10% by weight of the emulsion; and calcipotriene, in about 0.005% by weight of the emulsion; and the emulsion further comprises safflower oil, in about 6.75% by weight of the emulsion. ### Claim 17 (depends on 1) The method of claim 1, wherein the emulsion comprises: Ceteth-20, in about 3.00% by weight of the emulsion; cetostearyl alcohol, in about 6.00% by weight of the emulsion; mineral oil, in about 12.38% by weight of the emulsion; petrolatum, in about 7.50% by weight of the emulsion; dimethicone, in about 1.00% by weight of the emulsion; butylated hydroxytoluene, in about 0.03% by weight of the emulsion; water, in about 56.505% by weight of the emulsion; glycerin, in about 5.00% by weight of the emulsion; urea, in about 0.64% by weight of the emulsion; citric acid, in about 0.42% by weight of the emulsion; sodium citrate, in about 0.32% by weight of the emulsion; methylparaben, in about 0.30% by weight of the emulsion; propylparaben, in about 0.10% by weight of the emulsion; betamethasone dipropionate, in about 0.05% by weight of the emulsion; and calcipotriene, in about 0.005% by weight of the emulsion; and the emulsion further comprises safflower oil, in about 6.75% by weight of the emulsion. ### Claim 18 (depends on 1) The method of claim 1, wherein the emulsion comprises: Ceteth-20, in about 3.00% by weight of the emulsion; cetostearyl alcohol, in about 6.00% by weight of the emulsion; mineral oil, in about 12.38% by weight of the emulsion; petrolatum, in about 7.50% by weight of the emulsion; dimethicone, in about 1.00% by weight of the emulsion; butylated hydroxytoluene, in about 0.03% by weight of the emulsion; water, in about 56.49% by weight of the emulsion; glycerin, in about 5.00% by weight of the emulsion; urea, in about 0.64% by weight of the emulsion; citric acid, in about 0.42% by weight of the emulsion; sodium citrate, in about 0.32% by weight of the emulsion; methylparaben, in about 0.30% by weight of the emulsion; propylparaben, in about 0.10% by weight of the emulsion; betamethasone dipropionate, in about 0.05% by weight of the emulsion; and tretinoin, in about 0.02% by weight of the emulsion; and the emulsion further comprises safflower oil, in about 6.75% by weight of the emulsion. ### Claim 19 (depends on 1) The method of claim 1, wherein the propellant is selected from the group consisting of 1,1,1,2-tetrafluoroethane, 1,1,1,2,3,3,3-heptafluoropropane, and combinations/mixtures thereof. ### Claim 20 (depends on 1) The method of claim 1, wherein the purge gas is selected from the group consisting of nitrogen and argon.