# US 2024/0197631 A1 · Atomoxetine oral solution > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2024/0197631 A1 - Document ID: US20240197631A1 - Status: Published application - Kind: A1 - Application number: 18/532,721 - Filed: 2023-12-07 - Published: 2024-06-20 - Earliest claimed: 2022-12-07 - Assignees: OWP Pharmaceuticals, Inc. - Applicants: OWP Pharmaceuticals, Inc. - Inventors: Paul Sudhakar; Scott Boyer - Web page: https://patentgrep.com/patent/US20240197631A1 ## CPC - A61K 9/08: Solutions {(composition of solutions A61K47/00)} - A61K 9/0053: {Mouth and digestive tract, i.e. intraoral and peroral administration} - A61K 31/138: Aryloxyalkylamines, e.g. propranolol, tamoxifen, phenoxybenzamine (atenolol A61K31/165; pindolol A61K31/404; timolol A61K31/5377) - A61K 47/10: Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers - A61K 47/12: Carboxylic acids; Salts or anhydrides thereof - A61K 47/14: Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters - 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 47/36: Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin - A61K 47/46: Ingredients of undetermined constitution or reaction products thereof, e.g. skin, bone, milk, cotton fibre, eggshell, oxgall or plant extracts - 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) ## Abstract The present invention provides for an oral solution that includes atomoxetine, or pharmaceutically acceptable salt thereof, methods of manufacturing the oral solution, and methods of treating attention deficit hyperactivity disorder (ADHD) in a human subject that include orally administering the oral solution to a human subject in need thereof. ## Claims ### Claim 1 An oral solution comprising: (i) atomoxetine, or pharmaceutically acceptable salt thereof; (ii) antimicrobial preservative comprising methylparaben and sodium benzoate; (iii) buffering agent comprising citric acid and trisodium citrate dihydrate; (iv) sweetening agent comprising sucralose and sorbitol; (v) solvent comprising water, propylene glycol, and glycerin; (vi) optionally flavoring agent comprising cherry flavor; and (vii) optionally coloring agent comprising FD & C Red No. 40 and Allura Red AC. ### Claim 2 (depends on 1) The oral solution of claim 1, wherein the atomoxetine, or pharmaceutically acceptable salt thereof, is present in 10.5±2 mg/mL. ### Claim 3 (depends on 1) The oral solution of claim 1, wherein the atomoxetine is present in 11.43±2 mg/mL as the hydrochloride salt. ### Claim 4 (depends on 1) The oral solution of claim 1, wherein the atomoxetine is present in 10±2 mg/mL as the free base. ### Claim 5 (depends on 1) The oral solution of claim 1, wherein the antimicrobial preservative is present in 2±0.4 mg/mL. ### Claim 6 (depends on 1) The oral solution of claim 1, wherein the methylparaben is present in 1±0.2 mg/mL. ### Claim 7 (depends on 1) The oral solution of claim 1, wherein the sodium benzoate is present in 1±0.2 mg/mL. ### Claim 8 (depends on 1) The oral solution of claim 1, wherein the buffering agent is present in 2.84±0.5 mg/mL. ### Claim 9 (depends on 1) The oral solution of claim 1, wherein the citric acid is present in 1.50±0.3 mg/mL. ### Claim 10 (depends on 1) The oral solution of claim 1, wherein the trisodium citrate is present in 1.34±+0.27 mg/mL. ### Claim 11 (depends on 1) The oral solution of claim 1, wherein the sweetening agent is present in 57.25±10 mg/mL. ### Claim 12 (depends on 1) The oral solution of claim 1, wherein the sucralose is present in 1±0.2 mg/mL. ### Claim 13 (depends on 1) The oral solution of claim 1, wherein the sorbitol is present in 56.25±10 mg/mL. ### Claim 14 (depends on 1) The oral solution of claim 1, wherein the solvent is present in 906.7±50 mg/mL. ### Claim 15 (depends on 1) The oral solution of claim 1, wherein the water is present in 811.70±50 mg/mL. ### Claim 16 (depends on 1) The oral solution of claim 1, wherein the propylene glycol is present in 20±4 mg/mL. ### Claim 17 (depends on 1) The oral solution of claim 1, wherein the glycerin is present in 75±15 mg/mL. ### Claim 18 (depends on 1) The oral solution of claim 1, wherein the flavoring agent is present in 2±0.4 mg/mL. ### Claim 19 (depends on 1) The oral solution of claim 1, wherein the coloring agent is present in 0.002±0.0004 mg/mL. ### Claim 20 An oral solution comprising: (i) 11.43±3 mg/mL atomoxetine hydrochloride; (ii) antimicrobial preservative comprising 1±0.2 mg/mL methylparaben and 1±0.2 mg/mL sodium benzoate; (iii) buffering agent comprising 1.50±0.3 mg/mL citric acid and 1.34±0.27 mg/mL trisodium citrate dihydrate; (iv) sweetening agent comprising 1±0.2 mg/mL sucralose and 56.25±11 mg/mL sorbitol; (v) solvent comprising 811.70±50 mg/mL water, 20±4 mg/mL propylene glycol, and 75±15 mg/mL glycerin; (vi) flavoring agent comprising 2±0.4 mg/mL cherry flavor; and (vii) coloring agent comprising 0.001±0.0002 mg/mL FD & C Red No. 40 and 0.001±0.0002 mg/mL Allura Red AC. ### Claim 21 (depends on 20) A method of treating attention deficit hyperactivity disorder (ADHD) in a human subject, the method comprising orally administering the oral solution of claim 20 to a human subject in need thereof, in an amount and for a period of time sufficient to treat the ADHD. ### Claim 22 (depends on 21) The method of claim 21, further comprising the administration of a psychostimulant. ### Claim 23 (depends on 21) The method of claim 21, wherein the administration further provides for an enhancement in cognitive performance, including at least one of improved alertness, improved attention, and improved memory.