# US 2014/0154320 A1 · Extended-release formulation for reducing the frequency of urination and method of use thereof > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2014/0154320 A1 - Document ID: US20140154320A1 - Status: Published application - Kind: A1 - Application number: 14/172,649 - Filed: 2014-02-04 - Published: 2014-06-05 - Earliest claimed: 2010-07-08 - Assignees: Wellesley Pharmaceuticals, LLC - Applicants: Wellesley Pharmaceuticals, LLC - Inventors: David A. DILL - Web page: https://patentgrep.com/patent/US20140154320A1 ## CPC - A61K 31/60: Salicylic acid; Derivatives thereof - A61K 9/0002: {Galenical forms characterised by the drug release technique; Application systems commanded by energy} - A61K 31/12: Ketones - A61K 31/167: having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol - A61K 31/19: Carboxylic acids, e.g. valproic acid (salicylic acid A61K31/60) - A61K 31/192: having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid {(cannabinoids A61K31/658)} - A61K 31/216: of acids having aromatic rings, e.g. benactizyne, clofibrate - A61K 31/4025: not condensed and containing further heterocyclic rings, e.g. cromakalim - A61K 31/405: Indole-alkanecarboxylic acids; Derivatives thereof, e.g. tryptophan, indomethacin - A61K 31/46: 8-Azabicyclo [3.2.1] octane; Derivatives thereof, e.g. atropine, cocaine - A61K 31/4725: containing further heterocyclic rings - 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 13/00: Drugs for disorders of the urinary system - A61P 13/02: of urine or of the urinary tract, e.g. urine acidifiers - A61P 13/06: Anti-spasmodics - A61P 13/10: of the bladder - 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 Methods and compositions for reducing the frequency of urination are disclosed. One method comprises administering to a subject in need thereof an effective amount of a pharmaceutical composition comprising an analgesic agent formulated in an extended-release formulation. Another method comprises administering to a subject in need thereof an effective amount of a pharmaceutical composition comprising multiple active ingredients formulated for extended-release. Yet another method comprises administering to a subject in need thereof an effective amount of a diuretic followed with another administration of a pharmaceutical composition comprising an analgesic agent formulated for extended-release. ## Claims ### Claim at position 1 1-28. (canceled) ### Claim 29 A method for reducing the frequency of urination, comprising: administering to a subject who desires to reduce the frequency of urination an effective amount of a pharmaceutical composition comprising acetaminophen formulated for extended-release, wherein said acetaminophen is administered at a daily dose of 5 mg to 2000 mg. ### Claim 30 (depends on 29) The method of claim 29, wherein said acetaminophen is administered at a daily dose of 100 mg to 500 mg. ### Claim 31 (depends on 29) The method of claim 29, wherein said acetaminophen is administered at a daily dose of 500 mg to 2000 mg. ### Claim 32 (depends on 29) The method of claim 29, wherein said acetaminophen is administered at a daily dose of 50 mg to 1600 mg. ### Claim 33 (depends on 29) The method of claim 29, wherein said pharmaceutical composition further comprises one or more antimuscarinic agents. ### Claim 34 (depends on 29) The method of claim 29, wherein said pharmaceutical composition further comprises one or more antidiuretics. ### Claim 35 (depends on 29) The method of claim 29, wherein said pharmaceutical composition further comprises one or more spasmolytics. ### Claim 36 (depends on 29) The method of claim 29, wherein acetaminophen is embedded in a matrix of insoluble substance(s). ### Claim 37 (depends on 29) The method of claim 29, wherein said pharmaceutical composition comprises a polymer controlling release by dissolution controlled release. ### Claim 38 (depends on 29) The method of claim 29, wherein said pharmaceutical composition comprises a water soluble or water-swellable matrix-forming polymer. ### Claim 39 (depends on 29) The method of claim 29, wherein said pharmaceutical composition further comprises an enteric coating. ### Claim 40 (depends on 29) The method of claim 29, wherein said pharmaceutical composition is administered orally. ### Claim 41 (depends on 29) The method of claim 29, wherein said pharmaceutical composition is formulated for the oral administration. ### Claim 42 (depends on 29) The method of claim 29, wherein said pharmaceutical composition further comprises one or more analgesic agents selected from the group consisting of aspirin, ibuprofen, naproxen, naproxen sodium, indomethacin and nabumetone. ### Claim 43 A method for reducing the frequency of urination, comprising: administering to a subject who desires to reduce the frequency of urination an effective amount of a pharmaceutical composition comprising acetaminophen formulated for immediate release, wherein said acetaminophen is administered at a daily dose of 5 mg to 2000 mg. ### Claim 44 (depends on 43) The method of claim 43, wherein said acetaminophen is administered at a daily dose of 100 mg to 1500 mg. ### Claim 45 (depends on 43) The method of claim 43, wherein said acetaminophen is administered at a daily dose of 200 mg to 1000 mg. ### Claim 46 (depends on 43) The method of claim 43, wherein said pharmaceutical composition further comprises one or more antimuscarinic agents. ### Claim 47 (depends on 43) The method of claim 43, wherein said pharmaceutical composition further comprises one or more antidiuretics. ### Claim 48 (depends on 43) The method of claim 43, wherein said pharmaceutical composition further comprises one or more spasmolytics. ### Claim 49 (depends on 43) The method of claim 43, wherein said pharmaceutical composition further comprises one or more analgesic agents selected from the group consisting of aspirin, ibuprofen, naproxen, naproxen sodium, indomethacin and nabumetone. ### Claim 50 A method for reducing the frequency of urination, comprising: administering to a subject who desires to reduce the frequency of urination an effective amount of a pharmaceutical composition comprising acetaminophen formulated in an extended-release formulation having an immediate-release component and an extended-release component, wherein said acetaminophen is administered at a daily dose of 5 mg to 2000 mg. ### Claim 51 (depends on 50) The method of claim 50, wherein said pharmaceutical composition further comprises one or more antimuscarinic agents in said immediate-release component, or said extended-release component, or both components. ### Claim 52 (depends on 50) The method of claim 50, wherein said pharmaceutical composition further comprises one or more antidiuretics in said immediate-release component, or said extended-release component, or both components. ### Claim 53 (depends on 50) The method of claim 50, wherein said pharmaceutical composition further comprises one or more spasmolytics in said immediate-release component, or said extended-release component, or both components. ### Claim 54 (depends on 50) The method of claim 50, wherein said pharmaceutical composition further comprises one or more analgesic agents in said immediate-release component, or said extended-release component, or both components, wherein said one or more analgesic agents are selected from the group consisting of aspirin, ibuprofen, naproxen, naproxen sodium, indomethacin and nabumetone. ### Claim 55 (depends on 50) The method of claim 50, wherein said pharmaceutical composition is administered orally. ### Claim 56 (depends on 50) The method of claim 50, wherein said pharmaceutical composition is formulated for the oral administration. ### Claim 57 A method for reducing the frequency of urination, comprising: administering to a subject who desires to reduce the frequency of urination an effective amount of a pharmaceutical composition comprising acetaminophen formulated in an extended-release formulation having an immediate-release component and an extended-release component, wherein said acetaminophen is administered at a daily dose of 5 mg to 2000 mg and wherein said extended release component of said pharmaceutical composition is coated with a delayed release coating. ### Claim 58 (depends on 57) The method of claim 57, wherein said delayed release coating is enteric coating. ### Claim 59 (depends on 57) The method of claim 57, wherein said pharmaceutical composition is administered orally. ### Claim 60 (depends on 57) The method of claim 57, wherein said pharmaceutical composition is formulated for the oral administration. ### Claim 61 (depends on 57) The method of claim 57, wherein said pharmaceutical composition further comprises one or more analgesic agents selected from the group consisting of aspirin, ibuprofen, naproxen, naproxen sodium, indomethacin and nabumetone. ### Claim 62 (depends on 61) The method of claim 61, wherein said analgesic agents is administered at a daily dose of 5 mg to 2000 mg and wherein said extended release component of said pharmaceutical composition is coated with a delayed release coating.