Claims for Patent: 11,389,401

Summary for Patent: 11,389,401

Title:	Combination therapy for COPD
Abstract:	Aerosol formulations comprising glycopyrronium bromide in combination with formoterol are useful for the prevention or treatment of chronic obstructive pulmonary disease. The formulation further comprises a HFA propellant, a co-solvent, and an amount of inorganic acid sufficient to stabilize both the glycopyrronium bromide and the formoterol components. Optionally the formulation may further comprise beclometasone dipropionate.
Inventor(s):	Sauro BONELLI, Francesca Usberti, Enrico Zambelli
Assignee:	Chiesi Farmaceutici SpA
Application Number:	US16/161,427
Patent Claims:	1. A pressurized metered dose inhaler comprising a pharmaceutical aerosol solution composition, comprising: (a) glycopyrronium bromide in an amount sufficient to deliver 5 to 26 μg per actuation; and (b) formoterol fumarate in an amount sufficient to deliver 5 to 15 μg per actuation; dissolved in an HFA propellant and ethanol, wherein: said composition comprises an acid in an amount equivalent to 0.19 to 0.245 μg/μl of 1M HCl; said composition comprises ethanol in an amount of 5 to 25% w/w of the total composition; and said composition is free of excipients other than said HFA, ethanol, and HCl. 2. A pressurized metered dose inhaler according to claim 1, wherein said pharmaceutical aerosol solution composition further comprises one or more pharmaceutically active ingredients selected from the group consisting of a corticosteroid and a phosphodiesterase (IV) inhibitor. 3. A pressurized metered dose inhaler according to claim 1, wherein said pharmaceutical aerosol solution composition further comprises beclometasone dipropionate in an amount sufficient to deliver 50 to 250 μg per actuation. 4. A pressurized metered dose inhaler according to claim 1, wherein said pharmaceutical aerosol solution composition comprises glycopyrronium bromide in an amount in the range from 0.005 to 0.14% (w/w) of the composition. 5. A pressurized metered dose inhaler according to claim 1, wherein said pharmaceutical aerosol solution composition comprises formoterol fumarate in an amount in the range from 0.005 to 0.07% (w/w) of the composition. 6. An aerosol canister, comprising a pharmaceutical aerosol solution composition comprising: (a) glycopyrronium bromide in an amount sufficient to deliver 5 to 26 μg per actuation; and (b) formoterol fumarate in an amount sufficient to deliver 5 to 15 μg per actuation; dissolved in an HFA propellant and ethanol, wherein: said composition comprises an acid in an amount equivalent to 0.19 to 0.245 μg/μl of 1M HCl; said composition comprises ethanol in an amount of 5 to 25% w/w of the total composition; and said composition is free of excipients other than said HFA, ethanol, and HCl. 7. A kit-of-parts, comprising a pharmaceutical aerosol solution composition comprising: (a) glycopyrronium bromide in an amount sufficient to deliver 5 to 26 μg per actuation; and (b) formoterol fumarate in an amount sufficient to deliver 5 to 15 μg per actuation; dissolved in an HFA propellant and ethanol, wherein: said composition comprises an acid in an amount equivalent to 0.19 to 0.245 μg/μl of 1M HCl; said composition comprises ethanol in an amount of 5 to 25% w/w of the total composition; and said composition is free of excipients other than said HFA, ethanol, and HCl, 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 a corticosteroid and a phosphodiesterase (IV) inhibitors. 8. A pressurized metered dose inhaler according to claim 1, wherein said pharmaceutical aerosol solution composition further comprises beclometasone dipropionate in an amount in the range from 0.07 to 0.41% (w/w) of the composition. 9. A pressurized metered dose inhaler according to claim 1, in which an aerosol canister is fitted into a channelling device. 10. A pressurized metered dose inhaler according to claim 9, wherein said channelling device comprises a valve actuator and a cylindrical or cone-like passage through which said pharmaceutical aerosol solution composition may be delivered from the filled canister via the metering valve to the mouth of a patient. 11. An aerosol canister according to claim 6, which has part or all of its internal surface lined with an inert organic coating. 12. An aerosol canister according to claim 11, wherein said inert organic coating is selected from the group consisting of an epoxy-phenol resin, a perfluorinated polymer, a polyether sulfone, a fluorinated-ethylene-propylene polyether sulfone, a polyamide, a polyimide, a polyamideimide, a polyphenylene sulphide, and mixtures thereof.