Claims for Patent: 10,806,701

Summary for Patent: 10,806,701

Title:	Aerosol formulation for COPD
Abstract:	Stable aerosol solution formulations comprising glycopyrronium bromide are useful for administration to patients with COPD and other respiratory conditions.
Inventor(s):	Sauro BONELLI, Francesca Usberti, Enrico Zambelli
Assignee:	Chiesi Farmaceutici SpA
Application Number:	US14/791,553
Patent Claims:	1. A pharmaceutical composition for use with a pressurized metered dose inhaler, comprising glycopyrronium bromide dissolved in HFA-134a and ethanol, wherein: the composition comprises an amount of hydrochloric acid equivalent to 0.005 to 1.0 μg/μl of 1M hydrochloric acid; the composition comprises glycopyrronium bromide in an amount of 0.015 to 0.04% w/w of the composition; the composition comprises ethanol in an amount of 10 to 15% w/w of the composition; and the composition comprises HFA-134a in an amount of 85 to 90% w/w of the composition. 2. A composition according to claim 1, comprising an amount of hydrochloric acid equivalent to 0.18 to 0.32 μg/μl 1M hydrochloric acid. 3. A composition according to claim 1, comprising one or more pharmaceutically active ingredients selected from the group consisting of beta-2-agonists, corticosteroids, antimuscarinic agents, and phosphodiesterase (IV) inhibitors. 4. A composition according to claim 3, comprising formoterol fumarate. 5. A composition according to claim 3, comprising beclometasone dipropionate. 6. A metered dose inhaler, comprising a pharmaceutical composition according to claim 1. 7. A kit-of-parts, comprising: a pharmaceutical composition according to claim 1; and one or more pharmaceutically active ingredients for separate, sequential, or simultaneous administration; wherein the one or more pharmaceutically active ingredients are selected from the group consisting of beta-2-agonists, corticosteroids, antimuscarinic agents, and phosphodiesterase (IV) inhibitors. 8. A composition according to claim 1, wherein the composition comprises an amount of hydrochloric acid equivalent to 0.099 to 0.74 μg/μl of 1M hydrochloric acid. 9. A metered dose inhaler according to claim 6, comprising a metering valve capable of delivering a volume of about 63 μl per actuation. 10. A composition according to claim 1, wherein the glycopyrronium bromide is the racemic mixture (3S,2′R),(3R,2′S)-3-[(cyclopentylhydroxyphenylacetyl)oxy]-1,1-dimethylpyrrolidinium bromide. 11. A composition according to claim 1, comprising water in an amount less than 0.5% w/w of the composition. 12. A composition according to claim 1, comprising water in an amount 0.005 to 0.5% w/w of the composition. 13. A composition according to claim 1, wherein the composition is free of excipients other than the ethanol, the HFA-134a, and the hydrochloric acid.