# US 11,304,933 B2 · Fast acting orally disintegrating film > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,304,933 B2 - Document ID: US11304933B2 - Status: Granted - Kind: B2 - Application number: 16/569,979 - Filed: 2019-09-13 - Published: 2020-01-02 - Granted: 2022-04-19 - Earliest claimed: 2015-06-23 - Assignees: Taho Pharmaceuticals Ltd. - Applicants: TAHO Pharmaceuticals Ltd. - Inventors: Catherine Lee; Chien-Chiao Wang - Web page: https://patentgrep.com/patent/US11304933B2 ## CPC - A61K 31/4178: not condensed 1,3-diazoles and containing further heterocyclic rings, e.g. pilocarpine, nitrofurantoin - A61K 9/0056: {Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals} - A61K 9/7007: {Drug-containing films, membranes or sheets (A61K9/0041, A61K9/0043, A61K9/006, A61K9/0063 take precedence)} - A61K 47/10: Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers - A61K 47/26: Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin - A61K 47/32: Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers {, poly(meth)acrylates, or polyvinyl pyrrolidone} - A61K 47/36: Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin - A61K 47/38: Cellulose; Derivatives thereof - A61P 1/08: for nausea, cinetosis or vertigo; Antiemetics - 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 A fast acting orally disintegrating film (ODF) for treatment of various medical conditions including emesis that has a simple formulation, easy to manufacture and has similar pharmacokinetic profile to currently commercially available orally administered drug products is provided. The ODF comprises an active pharmaceutical ingredient such as ondansetron or a pharmaceutical acceptable salt thereof in an amount of 2 to 24 mg, at least one hydrophilic film forming polymer in an amount of at least 8% by weight of the film, wherein the at least one hydrophilic film forming polymer is characterized by having a molecular weight of 5000 to 50000 Da, and a water soluble excipient in an amount of 10 to 30% by weight of the film. The present invention also provides a method for preparing the ODF that remains stable over a period of time under a normal pharmacologically storage condition and a method for treating or preventing various medical conditions such as nausea or vomiting or a treatment method mediated through antagonizing action of 5HT at 5-HT3 receptor by administering the ODF to a patient in need thereof. ## Claims ### Claim 1 An orally disintegrating film, comprising: ondansetron or a pharmaceutical acceptable salt thereof in an amount of about 2 to about 24 mg; a first hydrophilic film forming polymer in a total amount of from about 15% to about 50% by weight of said film, wherein said first hydrophilic film forming polymer is characterized by having a molecular weight of about 5000 Da to about 50000 Da and viscosity of about 3 cps or about 6 cps; and a second hydrophilic film forming polymer having a molecular weight between about 50000 Da to about 60000 Da and viscosity of about 15 cps, wherein said first hydrophilic film forming polymer is mixed with said second hydrophilic film forming polymer in a ratio from about 0.3:1 to about 7:1; and the orally disintegrating film disintegrates within about 30 seconds in about 20 cc of water at about 37 degrees Celsius and lightly shaken. ### Claim 2 (depends on 1) The orally disintegrating film of claim 1, comprising a mixture of said first hydrophilic film forming polymer to said second hydrophilic film forming polymer in a ratio from about 0.5:1 to about 7:1. ### Claim 3 (depends on 1) The orally disintegrating film of claim 1, comprising said first hydrophilic film forming polymer in a total amount of from about 20% to about 50% by weight of said film. ### Claim 4 (depends on 1) The orally disintegrating film of claim 1, wherein said first hydrophilic film forming polymer comprises at least one member selected from hydroxylpropylmethylcellulose (HPMC), hydroxypropylcellulose, carboxymethylcellulose, polysaccharide polymer and povidone. ### Claim 5 (depends on 1) The orally disintegrating film of claim 1, wherein said second hydrophilic film forming polymer comprises at least one member selected from hydroxylpropylmethylcellulose (HPMC), hydroxypropylcellulose, carboxymethylcellulose, polysaccharide polymer and povidone. ### Claim 6 (depends on 1) The orally disintegrating film of claim 1, further comprising a water-soluble excipient. ### Claim 7 (depends on 1) The orally disintegrating film of claim 1, wherein the water-soluble excipient comprises polyethylene glycol (PEG) in an amount of about 10% to about 30% by weight of said film. ### Claim 8 (depends on 1) The orally disintegrating film of claim 1, further comprising one or more flavoring agent, sweetening agent and/or coloring agent. ### Claim 9 An orally administered film characterized by a pre-drying solution blend with a measured viscosity of about 2000 to about 10000 cps, wherein the pre-drying solution blend comprises: an active pharmaceutical ingredient comprising ondansetron or pharmaceutical acceptable salt thereof in an amount of about 2 to about 24 mg; a first hydrophilic film forming polymer comprising hydroxylpropylmethylcellulose (HPMC) in an amount of from about 15% to about 50% by weight of the film, said first hydrophilic film forming polymer is characterized by having a molecular weight of about 5000 Da to about 50000 Da and viscosity of about 3 cps or about 6 cps; a second hydrophilic film forming polymer comprising HPMC characterized by having a molecular weight of between about 50000 Da to about 60000 Da and viscosity of about 15 cps, wherein said first hydrophilic film forming polymer is mixed with said second film forming polymer in a ratio from about 0.3:1 to about 7:1. ### Claim 10 (depends on 9) The orally administered film of claim 9, comprising a mixture of said first hydrophilic film forming polymers to said second hydrophilic film forming polymers in a ratio from about 0.5:1 to about 7:1. ### Claim 11 (depends on 9) The orally administered film of claim 9, comprising said first hydrophilic film forming polymer in an amount of from about 20% to about 50% by weight of said film. ### Claim 12 (depends on 9) The orally administered film of claim 9, further comprising one or more flavoring agent, sweetening agent and/or coloring agent.