# US 11,433,037 B2 · Oral dosage form containing a fast release exterior coating > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,433,037 B2 - Document ID: US11433037B2 - Status: Granted - Kind: B2 - Application number: 15/641,448 - Filed: 2017-07-05 - Published: 2018-01-11 - Granted: 2022-09-06 - Earliest claimed: 2016-07-05 - Assignees: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC - Applicants: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC - Inventors: Christopher Joseph Pulford - Web page: https://patentgrep.com/patent/US11433037B2 ## CPC - A61K 31/167: having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol - A61K 9/0053: {Mouth and digestive tract, i.e. intraoral and peroral administration} - A61K 9/2054: {Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose} - A61K 9/2826: {Sugars or sugar alcohols, e.g. sucrose; Derivatives thereof} - A61K 9/2866: {Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose} - A61K 9/2886: {having two or more different drug-free coatings; Tablets of the type inert core-drug layer-inactive layer (of the type active core-drug layer-inactive layer A61K9/209)} - A61K 31/137: Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine {or methadone} - A61K 31/138: Aryloxyalkylamines, e.g. propranolol, tamoxifen, phenoxybenzamine (atenolol A61K31/165; pindolol A61K31/404; timolol A61K31/5377) - A61K 31/485: Morphinan derivatives, e.g. morphine, codeine - A61P 11/00: Drugs for disorders of the respiratory system - A61P 25/34: Tobacco-abuse - A61P 29/00: Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID] - A61P 31/16: for influenza or rhinoviruses - A61P 37/08: Antiallergic agents (antiasthmatic agents A61P11/06; ophthalmic antiallergics A61P27/14) - A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00 - 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 Aspects of the present invention are directed to an oral dosage form comprising a core containing one more active ingredients and a fast-release exterior coating. The fast release exterior coating includes a water soluble polymer; a saccharide or sugar alcohol, or a combination thereof, and a flavoring. The flavoring may be a warming sensate that is released in the oral cavity of the user after inserting the dosage form in his or her mouth. ## Claims ### Claim 1 A coated oral dosage form that provides a sensorial experience in the oral cavity of the user, comprising: a core comprising between about 300 mg and about 400 mg acetaminophen, between about 5 mg and about 15 mg dextromethorphan, and between about 2.5 mg and about 7.5 mg phenylephrine; a fast-release exterior coating comprising: between about 2 mg and about 6 mg hydroxypropylmethylcellulose and polyethylene glycol, between about 3 mg and about 5 mg maltodextrin; and between about 0.5 mg and about 2.5 mg warming sensate; and an intermediate coating comprising between about 10 mg and about 20 mg hydroxypropylmethylcellulose and polyethylene glycol. ### Claim 2 (depends on 1) The coated oral dosage form of claim 1, wherein the flavoring further comprises a flavor selected from the group consisting of menthol, peppermint, wintergreen, sweet mint, spearmint, vanillin, chocolate, coffee, cinnamon, clove, tobacco, citrus and fruit flavors or mixtures thereof. ### Claim 3 (depends on 1) The coated oral dosage form of claim 1, wherein the fast release exterior coating has a thickness of between about 100 μm and about 100 μm. ### Claim 4 (depends on 3) The coated oral dosage form of claim 3, wherein the fast release exterior coating has a thickness of between about 40 μm and about 80 μm. ### Claim 5 (depends on 1) The coated oral dosage form of claim 1, wherein the fast release exterior coating has a weight of between about 0.5% (w/w) and about 20% (w/w) of the oral dosage form. ### Claim 6 (depends on 1) The coated oral dosage form of claim 1, wherein the core is a caplet. ### Claim 7 (depends on 1) The coated oral dosage form of claim 1, wherein the intermediate coating has a thickness of between about 10 μm and about 100 μm. ### Claim 8 (depends on 1) The coated oral dosage form of claim 1, wherein the coating extends evenly around the entire exterior surface of the oral dosage form. ### Claim 9 (depends on 1) The coated oral dosage form of claim 1, wherein the intermediate coating has a thickness of between about 50 μm and about 70 μm. ### Claim 10 (depends on 7) The coated oral dosage form of claim 7, wherein the intermediate coating has a thickness of between about 50 μm and about 70 μm. ### Claim 11 (depends on 1) The coated oral dosage form of claim 1 comprising dextromethorphan as dextromethorphan bromide in an amount of 10 mg and phenylephrine as phenylephrine hydrochloride in an amount of 5 mg. ### Claim 12 (depends on 1) A method of treating the symptoms of cold and/or flu, and/or allergies comprising administering to a human subject in need thereof a coated oral dosage form as described in claim 1. ### Claim 13 A coated oral dosage form that provides a sensorial experience in the oral cavity of the user, comprising: a core comprising between about 300 and about 400 mg acetaminophen, between about 10 mg and about 15 mg diphenhydramine, and between about 2.5 mg and about 7.5 mg phenylephrine; a fast-release exterior coating comprising between about 2 mg and about 6 mg hydroxypropylmethylcellulose; between about 3 mg and about 5 mg maltodextrin; and between about 0.5 mg and about 2.5 mg of a warming sensate; and an intermediate coating comprising between about 10 mg and about 20 mg hydroxypropylmethylcellulose. ### Claim 14 (depends on 13) The coated oral dosage form of claim 13 comprising diphenhydramine as diphenhydramine hydrochloride in an amount of 12.5 mg and phenylephrine as phenylephrine hydrochloride in an amount of 5 mg. ### Claim 15 (depends on 13) The coated oral dosage form of claim 13, wherein the flavoring further comprises a flavor selected from the group consisting of menthol, peppermint, wintergreen, sweet mint, spearmint, vanillin, chocolate, coffee, cinnamon, clove, tobacco, citrus and fruit flavors or mixtures thereof. ### Claim 16 (depends on 13) The coated oral dosage form of claim 13, wherein the fast release exterior coating has a thickness of between about 10 μm and about 100 μm. ### Claim 17 (depends on 16) The coated oral dosage form of claim 16, wherein the fast-release exterior coating has a thickness between about 40 μm and about 80 μm. ### Claim 18 (depends on 13) The coated oral dosage form of claim 13, wherein the fast release exterior coating has a weight of between about 0.5% (w/w) and about 20% (w/w) of the oral dosage form. ### Claim 19 (depends on 13) The coated oral dosage form of claim 13, wherein the intermediate coating has a thickness of between about 10 μm and about 100 μm. ### Claim 20 (depends on 19) The coated oral dosage form of claim 19, wherein the intermediate coating has a thickness of between about 50 μm and about 70 μm. ### Claim 21 (depends on 13) The coated oral dosage form of claim 13, wherein the fast release exterior coating extends evenly around the entire exterior surface of the oral dosage form. ### Claim 22 (depends on 13) The coated oral dosage form of claim 13, wherein the core is a caplet. ### Claim 23 (depends on 13) A method of treating the symptoms of cold and/or flu, and/or allergies, comprising administering to a human subject in need thereof a coated oral dosage form as described in claim 13. ### Claim 24 A coated oral dosage form that provides a sensorial experience in the oral cavity of the user, comprising: a core comprising between about 300 mg and about 400 mg acetaminophen, between about 5 mg and about 15 mg dextromethorphan, and between about 2.5 mg and about 7.5 mg phenylephrine; a fast-release exterior coating comprising: between about 2 mg and about 6 mg hydroxypropylmethylcellulose, between about 3 mg and about 5 mg maltodextrin; and between about 0.5 mg and about 2.5 mg warming sensate; and. an intermediate coating comprising between about 10 mg and about 20 mg hydroxypropylmethylcellulose. ### Claim 25 (depends on 24) The coated oral dosage form of claim 24 comprising dextromethorphan as dextromethorphan bromide in an amount of 10 mg and phenylephrine as phenylephrine hydrochloride in an amount of 5 mg. ### Claim 26 (depends on 24) The coated oral dosage form of claim 24, wherein the fast release exterior coating has a thickness of between about 10 μm and about 100 μm. ### Claim 27 (depends on 24) The coated oral dosage form of claim 24, wherein the fast release exterior coating has a weight of between about 0.5% (w/w) and about 20% (w/w) of the oral dosage form. ### Claim 28 A coated oral dosage form that provides a sensorial experience in the oral cavity of the user, comprising: a core comprising between about 300 and about 400 mg acetaminophen, between about 10 mg and about 15 mg diphenhydramine, and between about 2.5 mg and about 7.5 mg phenylephrine; a fast-release exterior coating comprising between about 2 mg and about 6 mg hydroxypropylmethylcellulose and polyethylene glycol; between about 3 mg and about 5 mg maltodextrin; and between about 0.5 mg and about 2.5 mg of a warming sensate; and an intermediate coating comprising between about 10 mg and about 20 mg hydroxypropylmethylcellulose and polyethylene glycol. ### Claim 29 (depends on 28) The coated oral dosage form of claim 28 comprising diphenhydramine as diphenhydramine hydrochloride in an amount of 12.5 mg and phenylephrine as phenylephrine hydrochloride in an amount of 5 mg. ### Claim 30 (depends on 28) The coated oral dosage form of claim 28, wherein the intermediate coating has a thickness of between about 10 μm and about 100 μm. ### Claim 31 (depends on 28) The coated oral dosage form of claim 28, wherein the fast release exterior coating has a weight of between about 0.5% (w/w) and about 20% (w/w) of the oral dosage form.