# US 10,945,952 B2 · Rinse-off compositions and uses thereof for delivery of active agents > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,945,952 B2 - Document ID: US10945952B2 - Status: Granted - Kind: B2 - Application number: 16/820,128 - Filed: 2020-03-16 - Published: 2020-09-17 - Granted: 2021-03-16 - Earliest claimed: 2019-03-14 - Assignees: Crescita Therapeutics Inc. - Applicants: Crescita Therapeutics Inc. - Inventors: Gary Robert Kelm; Wade Hull; Carolyn Shawn Murphy - Web page: https://patentgrep.com/patent/US10945952B2 ## CPC - A61K 9/10: Dispersions; Emulsions - A61K 8/04: Dispersions; Emulsions - A61K 8/368: with carboxyl groups directly bound to carbon atoms of aromatic rings - A61K 8/416: {Quaternary ammonium compounds (A61K8/35 takes precedence)} - A61K 8/463: {containing sulfuric acid derivatives, e.g. sodium lauryl sulfate} - A61K 8/63: Steroids; Derivatives thereof - A61K 8/731: {Cellulose; Quaternized cellulose derivatives} - A61K 8/891: saturated, e.g. dimethicone, phenyl trimethicone, C24-C28 methicone or stearyl dimethicone - A61K 8/92: Oils, fats or waxes; Derivatives thereof, e.g. hydrogenation products 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 9/107: Emulsions {; Emulsion preconcentrates; Micelles (composition of emulsions A61K47/00)} - A61K 31/573: substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone - A61K 47/18: Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids - A61K 47/20: containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids - A61K 47/34: Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers (A61K47/10 takes precedence) - A61K 47/38: Cellulose; Derivatives thereof - A61K 47/44: Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin (synthetic glycerides, e.g. medium-chain triglycerides, A61K47/14) - A61Q 5/02: Preparations for cleaning the hair - A61Q 19/10: Washing or bathing preparations - A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca - A61K 2800/5426: cationic - A61K 2800/596: Mixtures of surface active compounds - 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) - A61Q: SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS ## Abstract The present application relates to a rinse-off composition comprising an oil phase and an aqueous surfactant matrix, wherein one or more active agents are dissolved in one or more non-polar, water-immiscible solvents, and the oil phase is dispersed in the aqueous surfactant matrix. The present application also relates to methods of delivering the active agent(s) to a subject in need thereof topically, for example to the skin, the hair, and scalp. The present application also relates to use of the rinse-off compositions to treat and/or prevent topical conditions such as dermatitis and psoriasis. In some embodiments, the rinse-off compositions of the present application are shampoo compositions. ## Claims ### Claim 1 A rinse-off composition comprising a) an oil phase comprising one or more non-polar, water-immiscible solvents; b) an aqueous surfactant matrix comprising one or more surfactants; and c) one or more active agents comprising halobetasol propionate, wherein the oil phase is dispersed in the aqueous surfactant matrix, and wherein the total amount of the one or more surfactants in the composition is less than 13.0 wt %. ### Claim 2 (depends on 1) The rinse-off composition of claim 1, wherein the aqueous surfactant matrix further comprises one or more polymers. ### Claim 3 (depends on 2) The rinse-off composition of claim 2, wherein the one or more surfactants are one or more anionic surfactants and the one or more polymers are one or more cationic polymers. ### Claim 4 (depends on 3) The rinse-off composition of claim 3, wherein the one or more anionic surfactants and the one or more cationic polymers are in coacervates. ### Claim 5 (depends on 1) The rinse-off composition of claim 1, wherein the aqueous surfactant matrix further comprises water and is substantially free of ethanol and other water-miscible solvents. ### Claim 6 (depends on 3) The rinse-off composition of claim 3, wherein the one or more anionic surfactants are selected from sodium laureth sulfate, sodium lauryl sulfate, and mixtures thereof. ### Claim 7 (depends on 3) The rinse-off composition of claim 3, wherein the one or more cationic polymers are selected from cationic cellulose derivatives, cationic guar derivatives, acrylamidopropyl trimonium chloride copolymer with acrylamide, homopolymers derived from the monomer diallyldimethylammonium chloride, copolymers derived from diallyldimethylammonium chloride and acrylamide, homopolymers derived from a monomer having the Formula (I), copolymers derived from a monomer having the Formula (I), copolymers derived from diallyldimethylammonium chloride, and copolymers derived from a monomer having the Formula (I) and diallyldimethylammonium chloride; wherein the monomer having the formula Formula (I) has a structure: wherein R1 is H or CH3; Y is O or NH; Z is C1-6alkylene; R2, R3, and R4 are each independently C1-22alkyl or C1-22hydroxyalkyl; and X is a monovalent anion selected from halide and C1-4alkyl sulfate. ### Claim 8 (depends on 7) The rinse-off composition of claim 7, wherein the cationic cellulose derivatives are polymeric quaternary ammonium salts derived from the reaction of hydroxyethyl cellulose with a trimethylammonium-substituted epoxide. ### Claim 9 (depends on 2) The rinse-off composition of claim 2, wherein the one or more surfactants further comprises one or more amphoteric surfactants and/or one or more non-ionic surfactants. ### Claim 10 (depends on 9) The rinse-off composition of claim 9, wherein the one or more amphoteric surfactants are selected from amphocarboxylates, alkyl betaines, amidoalkylbetaines, amidoalkylsultaines, amphophosphates, phosphobetaines, pyrophosphobetaines, carboxyalkyl alkyl polyamines, cocoamidopropyl betaine, and mixtures thereof. ### Claim 11 (depends on 9) The rinse-off composition of claim 9, wherein the one or more non-ionic surfactants are selected from polysorbate 20, C8-22alkyl glucosides, coconut fatty acid monoethanolamides, coconut fatty acid diethanolamides, cocomonoethanolamide, and mixtures thereof. ### Claim 12 (depends on 1) The rinse-off composition of claim 1, wherein the one or more non-polar, water-immiscible solvents are selected from di-isopropyl adipate, peppermint oil, coconut oil, and mixtures thereof. ### Claim 13 (depends on 12) The rinse-off composition of claim 12, wherein the oil phase further comprises one or more water-immiscible or water-insoluble components selected from dimethicone, cyclomethicone, fatty alcohols, and mixtures thereof. ### Claim 14 (depends on 1) The rinse-off composition of claim 1, wherein about 25 wt % to about 50 wt % of the one or more active agents are solubilized in the one or more non-polar water-immiscible solvents. ### Claim 15 (depends on 1) The rinse-off composition of claim 1, wherein the composition is a facial wash, a hand wash, a body wash, a facial cleanser, a hand cleanser, a body cleanser, a bath product, a shower product, a shampoo composition, a hair conditioning composition, or a shampoo and hair conditioning composition. ### Claim 16 (depends on 1) The rinse-off composition of claim 1, wherein the total amount of surfactant in the composition is 5.1 wt % to 12.9 wt %. ### Claim 17 (depends on 1) The rinse-off composition of claim 1, wherein about 27 wt % to about 45 wt % of the one or more active agents are solubilized in the one or more non-polar water-immiscible solvents. ### Claim 18 (depends on 1) A method of topically administering one or more active agents to a subject in need thereof comprising: a) topically applying a rinse-off composition of claim 1 to the subject; b) adding water and optionally creating a lather; and c) rinsing the composition. ### Claim 19 (depends on 18) The method of claim 18, wherein steps a) and b) are separated by less than about 15 minutes, less than about 10 minutes, or less than about 5 minutes. ### Claim 20 (depends on 18) The method of claim 18, wherein the rinse-off composition is applied to the skin, the hair, scalp, or another anatomical surface of the subject. ### Claim 21 (depends on 18) The method of claim 18, wherein an effective amount of the rinse-off composition is applied, wherein the effective amount is an amount effective to treat a disease, disorder, or condition treatable with the one or more active agents and/or to treat symptoms of a disease, disorder, or condition treatable with the one or more active agents. ### Claim 22 (depends on 21) The method of claim 21, wherein the disease, disorder, or condition is selected form the group consisting of inflammatory skin diseases, inflammatory scalp disease, fungal skin disease, fungal scalp disease, serborrheic dermatitis, psoriasis, acne, hyperpigmentation, pain, dry skin, dry scalp, and dandruff. ### Claim 23 (depends on 18) The method of claim 18, wherein the rinse-off composition is applied to the subject for less than 5 minutes to 15 minutes prior to the rinsing. ### Claim 24 (depends on 18) The method claim 18, wherein the rinse-off composition is a facial cleanser, a hand cleanser, a body cleanser, a facial wash, a hand wash, a body wash, a bath product, a shower product, a shampoo composition, a hair conditioning composition, or a shampoo and hair conditioning composition. ### Claim 25 (depends on 1) A method of treating a disease, disorder, or condition, or treating symptoms of a disorder, disease, or condition, with one or more active agents comprising: a) topically applying the rinse-off composition of claim 1 to a subject in need thereof; b) adding water and optionally creating a lather; and c) rinsing the composition, wherein the disease, disorder or condition is one that is treatable with the one or more active agents.