# US 12,594,241 B2 · Topiramate oral liquid suspension and use thereof > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,594,241 B2 - Document ID: US12594241B2 - Status: Granted - Kind: B2 - Application number: 18/462,651 - Filed: 2023-09-07 - Published: 2023-12-28 - Granted: 2026-04-07 - Earliest claimed: 2019-06-07 - Applicants: OWP Pharmaceuticals, Inc. - Inventors: Paul Sudhakar; Scott Boyer - Web page: https://patentgrep.com/patent/US12594241B2 ## CPC - A61K 9/08: Solutions {(composition of solutions A61K47/00)} - A61K 9/0053: {Mouth and digestive tract, i.e. intraoral and peroral administration} - A61K 31/36: Compounds containing methylenedioxyphenyl groups, e.g. sesamin - A61K 47/02: Inorganic compounds - 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 47/20: containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids - 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 47/38: Cellulose; Derivatives thereof - Y02A 50/30: Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change - 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) - Y02A: TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE ## Abstract Provided herein is an oral liquid suspension that includes topiramate, as well as methods of medical treatment that include orally administering the oral liquid suspension. ## Claims ### Claim 1 An oral liquid suspension comprising: 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate (topiramate); water; glycerin; propylene glycol; polyethylene glycol; methylparaben; sodium benzoate; xanthan gum; carboxymethyl cellulose; sodium phosphate; and microcrystalline cellulose and colloidal silicon dioxide, wherein the topiramate is present in 25+/−5 mg/mL. ### Claim 2 (depends on 1) The oral liquid suspension of claim 1, wherein the topiramate present in the oral liquid suspension has the following particle size distribution: D90 of not more than 200 microns, D50 of not more than 100 microns, and D10 of not more than 30 microns. ### Claim 3 (depends on 1) The oral liquid suspension of claim 1, wherein the topiramate present in the oral liquid suspension has the following particle size distribution: D90 of not more than 139 microns, D50 of not more than 64.8 microns, and D10 of not more than 24.65 microns. ### Claim 4 (depends on 1) The oral liquid suspension of claim 1, having a viscosity at 25° C. of 300-400 mPs. ### Claim 5 (depends on 1) The oral liquid suspension of claim 1, having a viscosity at 25° C. of 341.7±10 mPs. ### Claim 6 (depends on 1) The oral liquid suspension of claim 1, having a pH of 7.5-7.9. ### Claim 7 (depends on 1) The oral liquid suspension of claim 1, having a pH of 7.7±0.1. ### Claim 8 (depends on 1) The oral liquid suspension of claim 1, having a specific gravity of not more than 1.1049. ### Claim 9 (depends on 1) The oral liquid suspension of claim 1, having a specific gravity of not more than 1.2. ### Claim 10 (depends on 1) The oral liquid suspension of claim 1, further comprising a flavoring agent. ### Claim 11 (depends on 1) The oral liquid suspension of claim 1, further comprising cherry flavor as a flavoring agent. ### Claim 12 (depends on 1) The oral liquid suspension of claim 1, further comprising a coloring agent. ### Claim 13 (depends on 1) The oral liquid suspension of claim 1, further comprising FD&C red #40 and FD&C yellow #6 as a coloring agent. ### Claim 14 (depends on 1) The oral liquid suspension of claim 1, having a volume of 0.2 mL, 0.5 mL, 2.5 mL, 10 mL, 15 mL, or 20 mL. ### Claim 15 (depends on 1) The oral liquid suspension of claim 1, while packaged in a container, is essentially free from microbial growth for at least 24 months under ambient conditions. ### Claim 16 (depends on 1) The oral liquid suspension of claim 1, while packaged in a container, is essentially free from Escherichia coli for at least 24 months under ambient conditions. ### Claim 17 (depends on 1) The oral liquid suspension of claim 1, while packaged in a container, is essentially free from Burkholderia cepacia complex for at least 24 months under ambient conditions. ### Claim 18 (depends on 1) The oral liquid suspension of claim 1, which is an immediate release dosage form. ### Claim 19 (depends on 1) The oral liquid suspension of claim 1, which is an immediate release dosage form that exhibits in-vitro dissolution rate more than 88% of drug release within 30 minutes, when said dosage form is placed in a dissolution vessel filled with 900 ml of 0.1N HCL, pH 1.2 maintained at 37±0.5° C. and stirred at a paddle speed of 50 rpm using a USP Type II (paddle) apparatus. ### Claim 20 (depends on 1) The oral liquid suspension of claim 1, further comprising a sweetening agent. ### Claim 21 (depends on 20) The oral liquid suspension of claim 20, wherein the sweetening agent comprises sorbitol, saccharin, sucralose, or any combination thereof. ### Claim 22 (depends on 20) The oral liquid suspension of claim 20, wherein the sweetening agent comprises sorbitol. ### Claim 23 (depends on 20) The oral liquid suspension of claim 20, wherein the sweetening agent comprises saccharin. ### Claim 24 (depends on 20) The oral liquid suspension of claim 20, wherein the sweetening agent comprises sucralose. ### Claim 25 An oral liquid suspension comprising: 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate (topiramate); water; glycerin; propylene glycol; polyethylene glycol; methylparaben; sodium benzoate; xanthan gum; carboxymethyl cellulose; sodium phosphate; and microcrystalline cellulose and colloidal silicon dioxide, wherein the oral liquid suspension has a viscosity at 25° C. of 300-400 millipoises. ### Claim 26 (depends on 25) The oral liquid suspension of claim 25, comprising a sweetening agent. ### Claim 27 (depends on 26) The oral liquid suspension of claim 26, comprising sorbitol. ### Claim 28 (depends on 26) The oral liquid suspension of claim 26, comprising saccharin. ### Claim 29 (depends on 26) The oral liquid suspension of claim 26, comprising sucralose.