AEROSOL FORMULATION FOR COPD
Stable aerosol solution formulations comprising glycopyrronium bromide are useful for administration to patients with COPD and other respiratory conditions.
1 . A pharmaceutical composition, comprising glycopyrronium bromide dissolved in an HFA propellant and a co-solvent, wherein said composition comprises an amount of hydrochloric acid equivalent to 0.005 to 1.0 μg/μl of 1M hydrochloric acid.
2 . A composition according to claim 1 , wherein said composition comprises an amount of hydrochloric acid equivalent to 0.18 to 0.32 μg/μl of 1M hydrochloric acid.
3 . A composition according to claim 1 , wherein the co-solvent is ethanol.
4 . A composition according to claim 1 , comprising glycopyrronium bromide in an amount in the range of 0.005 to 0.14% w/w of the composition.
5 . 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.
6 . A composition according to claim 5 , comprising formoterol fumarate.
7 . A composition according to claim 5 , further comprising beclometasone dipropionate.
8 . A metered dose inhaler, comprising a pharmaceutical composition according to claim 1 .
9 . 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.
10 . A method of filling an aerosol canister with a pharmaceutical composition according to claim 1 , comprising:
a) preparing a solution comprising glycopyrronium bromide, 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.
11 . A method for the prevention and/or treatment of a respiratory disorder, comprising administering an effective amount of a composition according to claim 1 to a subject in need thereof.
12 . A method for the prevention and/or treatment of a respiratory disorder, comprising administering an effective amount of a composition according to claim 2 to a subject in need thereof.
13 . A method for the prevention and/or treatment of a respiratory disorder, comprising administering an effective amount of a composition according to claim 3 to a subject in need thereof.
14 . A method for the prevention and/or treatment of a respiratory disorder, comprising administering an effective amount of a composition according to claim 4 to a subject in need thereof.
15 . A method for the prevention and/or treatment of a respiratory disorder, comprising administering an effective amount of a composition according to claim 5 to a subject in need thereof.
16 . A method for the prevention and/or treatment of a respiratory disorder, comprising administering an effective amount of a composition according to claim 6 to a subject in need thereof.
17 . A method for the prevention and/or treatment of a respiratory disorder, comprising administering an effective amount of a composition according to claim 7 to a subject in need thereof.