# US 11,077,074 B2 · Compositions and methods useful for treatment of respiratory illness > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,077,074 B2 - Document ID: US11077074B2 - Status: Granted - Kind: B2 - Application number: 16/011,700 - Filed: 2018-06-19 - Published: 2018-11-29 - Granted: 2021-08-03 - Earliest claimed: 2006-04-21 - Assignees: The Procter & Gamble Company - Applicants: The Procter & Gamble Company - Inventors: Kelly Lee Schmeichel; Jayant Eknath Khanolkar; Douglas William Gledhill; Susan Elaine Criss; Niranjan Ramji; Elaine Rose Costeines - Web page: https://patentgrep.com/patent/US11077074B2 ## CPC - A61K 31/137: Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine {or methadone} - A61K 31/473: ortho- or peri-condensed with carbocyclic ring systems, e.g. acridines, phenanthridines - A61K 31/485: Morphinan derivatives, e.g. morphine, codeine - A61K 31/495: having six-membered rings with two {or more} nitrogen atoms as the only ring heteroatoms, e.g. piperazine {or tetrazines}(A61K31/48 takes precedence {; with three nitrogen atoms A61K31/53}) - A61K 31/519: ortho- or peri-condensed with heterocyclic rings - A61K 31/522: having oxo groups directly attached to the heterocyclic ring, e.g. hypoxanthine, guanine, acyclovir - A61K 31/55: having seven-membered rings, e.g. azelastine, pentylenetetrazole - A61K 31/616: by carboxylic acids, e.g. acetylsalicylic acid - A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca - A61P 11/00: Drugs for disorders of the respiratory system - A61P 11/02: Nasal agents, e.g. decongestants - 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 Disclosed are compositions including phenylephrine, its free and addition salt forms, and mixtures thereof, alone, or in combination with other pharmaceutical actives. The compositions have a pH of about 2 to about 5 and are substantially free of aldehydes. Also disclosed are methods of treating respiratory illness through administration of a composition comprising phenylephrine, its free and addition salt forms, and mixtures thereof alone, or in combination with other pharmaceutical actives, wherein the composition has a pH of from about 2 to about 5 and is substantially free of aldehydes. ## Claims ### Claim 1 A liquid composition comprising: (a) from about 0.001% to about 0.5% of phenylephrine hydrochloride, by weight of the liquid composition; (b) one or more additional actives selected from the group consisting of dextromethorphan, acetaminophen, doxylamine, guaifenesin, the free and addition salts thereof, and mixtures thereof; (c) a flavor which comprises one or more non-aldehydic aesthetic agents; (d) a sweetener selected from the group consisting of sugar alcohols, artificial sweeteners, and mixtures thereof; wherein the sugar alcohols are selected from the group consisting of glycerin, sorbitol, maltitol, mannitol, and mixtures thereof and the artificial sweeteners are selected from the group consisting of sodium saccharine, acesulfame potassium, sucralose, aspartame, monoammonium glycyrrhizinate, neohesperidin dihydrochalcone, thaumatin, neotame, cyclamates, and mixtures thereof; (e) a solvent selected from the group consisting of water, ethanol, propylene glycol, and mixtures thereof; (f) a chelating agent selected from the group consisting of disodium and calcium salts of ethylene diamine tetraacetic acid (EDTA), terasodium EDTA, sodium hexametaphosphate (SHMP), citric acid, phosphoric acid, di(hydroxyethyl)glycine, 8-hydroxyquinoline, and mixtures thereof; and (g) a reducing agent; wherein the liquid composition is a solution; wherein the liquid composition has a pH of from about 2 to about 5; wherein the liquid composition comprises a ratio of propylene glycol to glycerin of 1:1 to 3:1; and wherein the liquid composition comprises less than about 0.05% of total aldehydes, by weight of the liquid composition. ### Claim 2 (depends on 1) The liquid composition according to claim 1 comprising from about 0.0001% to about 10% of total additional actives, by weight of the liquid composition. ### Claim 3 (depends on 2) The liquid compositing according to claim 2 wherein at least one of the additional actives is dextromethorphan hydrobromide. ### Claim 4 (depends on 2) The liquid composition according to claim 2 wherein at least one of the additional actives is acetaminophen. ### Claim 5 (depends on 2) The liquid composition according to claim 2 which comprises from about 0.0001% to about 5% of total non-aldehydic aesthetic agents, by weight of the liquid composition. ### Claim 6 (depends on 5) The liquid composition according to claim 5 wherein at least one of the non-aldehydic aesthetic agents is an ester. ### Claim 7 (depends on 5) The liquid composition according to claim 5 wherein at least one of the non-aldehydic aesthetic agents is a ketone. ### Claim 8 (depends on 5) The liquid composition according to claim 5 wherein at least one of the non-aldehydic aesthetic agents is an alcohol. ### Claim 9 (depends on 5) The liquid composition according to claim 5 which comprises less than about 0.01% of total aldehydes, by weight of the liquid composition. ### Claim 10 (depends on 9) The liquid composition according to claim 9 comprising from about 40% to about 95% of total solvent, by weight of the liquid composition. ### Claim 11 (depends on 10) The liquid composition according to claim 10 comprising from about 50% to about 90% of total solvent, by weight of the liquid composition. ### Claim 12 (depends on 11) The liquid composition according to claim 11 comprising from about 60% to about 85% of total solvent, by weight of the liquid composition. ### Claim 13 (depends on 9) The liquid composition according to claim 9 wherein the sweetener comprises an artificial sweetener. ### Claim 14 (depends on 13) The liquid composition according to claim 13, further comprising a sugar alcohol. ### Claim 15 (depends on 14) The liquid composition according to claim 14 comprising from about 0.0001% to about 5% of total artificial sweetener, by weight of the liquid composition. ### Claim 16 (depends on 15) The liquid composition according to claim 15 comprising from about 0.0425% to about 3.5% of total artificial sweetener, by weight of the liquid composition. ### Claim 17 (depends on 16) The liquid composition according to claim 16 comprising from about 0.05% to about 2.0% of total artificial sweetener, by weight of the liquid composition. ### Claim 18 (depends on 14) The liquid composition according to claim 14 wherein the chelating agent is disodium EDTA. ### Claim 19 (depends on 14) The liquid composition according to claim 14 comprising from about 0% to about 30% of total sugar alcohol solution, by weight of the liquid composition. ### Claim 20 (depends on 19) The liquid composition according to claim 19 comprising from about 60% to about 80% of total sugar alcohol, by weight of the sugar alcohol solution. ### Claim 21 (depends on 20) The liquid composition according to claim 20 comprising from about 10% to about 25% of total sugar alcohol solution, by weight of the liquid composition. ### Claim 22 (depends on 21) The liquid composition according to claim 21 comprising from about 60% to about 80% of total sugar alcohol, by weight of the sugar alcohol solution.