Aerosol formulation for copd

Abstract

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.