# US 2018/0021301 A1 · Aerosol formulation for copd > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2018/0021301 A1 - Document ID: US20180021301A1 - Status: Published application - Kind: A1 - Application number: 15/697,791 - Filed: 2017-09-07 - Published: 2018-01-25 - Earliest claimed: 2009-12-23 - Assignees: Chiesi Farmaceutici S.p.A. - Applicants: Chiesi Farmaceutici S.p.A. - Inventors: Sauro Bonelli; Francesca Usberti; Enrico Zambelli - Web page: https://patentgrep.com/patent/US20180021301A1 ## CPC - A61K 31/40: having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil - A61K 9/008: {comprising drug dissolved or suspended in liquid propellant for inhalation via a pressurized metered dose inhaler [MDI]} - A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca - A61K 47/10: Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers - A61P 11/00: Drugs for disorders of the respiratory system - A61P 11/06: Antiasthmatics - A61P 11/08: Bronchodilators - B65B 3/00: Packaging plastic material, semiliquids, liquids or mixed solids and liquids, in individual containers or receptacles, e.g. bags, sacks, boxes, cartons, cans, or jars - B65B 7/16: Closing semi-rigid or rigid containers or receptacles not deformed by, or not taking-up shape of, contents, e.g. boxes or cartons - 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 - B65B: MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING (bundling and pressing devices for cigars A24C1/44; devices for tensioning and securing binders adapted to be supported by the article or articles to be bound B25B25/00; applying closure members to bottles, jars or similar containers B67B1/00-B67B6/00; concurrent cleaning, filling and closing of bottles B67C7/00; emptying bottles, jars, cans, casks, barrels or similar containers B67C9/00) ## Abstract The stable aerosol solution formulations comprising glycopyrronium chloride are useful for administration to patients with COPD and other respiratory conditions. ## Claims ### Claim 1 A pharmaceutical composition, comprising glycopyrronium chloride dissolved in an HFA propellant and optionally a co-solvent, wherein said composition comprises an amount of acid equivalent to 0.05 to 0.4 μg/μ1 of 1M HCl. ### Claim 2 (depends on 1) A composition according to claim 1, wherein said composition comprises an amount of acid equivalent to 0.19 to 0.25 μg/μl of 1M HCl. ### Claim 3 (depends on 1) A composition according to claim 1, wherein the co-solvent is ethanol. ### Claim 4 (depends on 1) A composition according claim 1, comprising glycopyrronium chloride in an amount of 0.005 to 0.83% w/w of the composition. ### Claim 5 (depends on 1) A composition according to claim 1, further comprising one or more pharmaceutically active ingredients selected from the group consisting of beta-2-agonists, corticosteroids, antimuscarinic agents, and phosphodiesterase (IV) inhibitors. ### Claim 6 (depends on 5) A composition according to claim 5, further comprising formoterol fumarate. ### Claim 7 (depends on 5) A composition according to claim 5, further comprising beclometasone dipropionate. ### Claim 8 (depends on 1) A metered dose inhaler, comprising a pharmaceutical composition according to claim 1. ### Claim 9 (depends on 1) A kit-of-parts, comprising a pharmaceutical composition according to claim 1 and further comprising one or more pharmaceutically active ingredients for separate, sequential or simultaneous administration, wherein said pharmaceutically active ingredients are selected from the group consisting of beta-2-agonists, corticosteroids, antimuscarinic agents, and phosphodiesterase (IV) inhibitors. ### Claim 10 (depends on 1) A method of filling an aerosol canister with a pharmaceutical composition according to claim 1, comprising: a) preparing a solution comprising glycopyrronium chloride, a co-solvent, a mineral acid and optionally a low volatility component; b) filling an open canister with the solution; c) placing a valve onto the canister and crimping; and d) pressure-filling the canister with HFA propellant through the valve. ### Claim 11 (depends on 1) A method for the prevention and/or treatment of chronic obstructive pulmonary disease, comprising administering an effective amount of a composition according to claim 1 to a subject in need thereof. ### Claim 12 (depends on 2) A method for the prevention and/or treatment of chronic obstructive pulmonary disease, comprising administering an effective amount of a composition according to claim 2 to a subject in need thereof. ### Claim 13 (depends on 3) A method for the prevention and/or treatment of chronic obstructive pulmonary disease, comprising administering an effective amount of a composition according to claim 3 to a subject in need thereof. ### Claim 14 (depends on 4) A method for the prevention and/or treatment of chronic obstructive pulmonary disease, comprising administering an effective amount of a composition according to claim 4 to a subject in need thereof. ### Claim 15 (depends on 5) A method for the prevention and/or treatment of chronic obstructive pulmonary disease, comprising administering an effective amount of a composition according to claim 5 to a subject in need thereof. ### Claim 16 (depends on 6) A method for the prevention and/or treatment of chronic obstructive pulmonary disease, comprising administering an effective amount of a composition according to claim 6 to a subject in need thereof. ### Claim 17 (depends on 7) A method for the prevention and/or treatment of chronic obstructive pulmonary disease, comprising administering an effective amount of a composition according to claim 7 to a subject in need thereof.