Claims for Patent: 10,940,110

Summary for Patent: 10,940,110

Title:	Method and system for the treatment of chronic COPD with nebulized anticholinergic administrations
Abstract:	A method is provided for improving lung function in COPD by administering a muscarinic antagonist with a high efficiency nebulizer.
Inventor(s):	William Gerhart, Ahmet Tutuncu
Assignee:	Sunovion Respiratory Development Inc
Application Number:	US16/217,765
Patent Claims:	1. A pharmaceutical composition, comprising an aqueous solution of glycopyrrolate having a volume of about 0.7 mL to about 1.0 mL, a glycopyrrolate concentration of about 25 μg/mL to about 400 μg/mL, and a pH of about 3 to about 5, wherein the solution is free of other bronchodilating agents and is substantially free of preservatives. 2. The pharmaceutical composition of claim 1, further comprising an organic acid. 3. The pharmaceutical composition of claim 2, wherein the organic acid is citric acid or a pharmaceutically acceptable salt thereof. 4. The pharmaceutical composition of claim 1, wherein the solution is substantially free of benzyl alcohol. 5. The pharmaceutical composition of claim 1, wherein the glycopyrrolate concentration is about 25 μg/mL. 6. The pharmaceutical composition of claim 1, wherein the volume is about 1 mL. 7. The pharmaceutical composition of claim 1, wherein the pharmaceutical composition is contained in a single dose ampule. 8. The pharmaceutical composition of claim 1, comprising an aqueous solution of glycopyrrolate having a volume of about 1.0 mL, a glycopyrrolate concentration of about 25 μg/mL, and a pH of about 3 to about 5, wherein the solution is free of other bronchodilating agents and is substantially free of preservatives. 9. The pharmaceutical composition of claim 8, wherein said aqueous solution further comprises citric acid or a pharmaceutically acceptable salt thereof. 10. A method of treating chronic obstructive pulmonary disease (COPD) in a subject comprising administering to the subject a pharmaceutical composition via a high efficiency nebulizer, wherein the pharmaceutical composition comprises an aqueous solution of glycopyrrolate having a volume of about 0.7 mL to about 1.0 mL, a glycopyrrolate concentration of about 25 μg/mL to about 400 μg/mL, and a pH of about 3 to about 5, wherein the solution is free of other bronchodilating agents and is substantially free of preservatives. 11. The method of claim 10, wherein the pharmaceutical composition further comprises an organic acid. 12. The method of claim 11, wherein the organic acid is citric acid or a pharmaceutically acceptable salt thereof. 13. The method of claim 10, wherein the solution is substantially free of benzyl alcohol. 14. The method of claim 10, wherein the glycopyrrolate concentration is about 25 μg/mL. 15. The method of claim 10, wherein the volume is about 1 mL. 16. The method of claim 10, wherein the pharmaceutical composition is contained in a single dose ampule. 17. The method of claim 10, wherein the pharmaceutical composition comprises an aqueous solution of glycopyrrolate having a volume of about 1.0 mL, a glycopyrrolate concentration of about 25 μg/mL, and a pH of about 3 to about 5, wherein the solution is free of other bronchodilating agents and is substantially free of preservatives. 18. The method of claim 17, wherein said aqueous solution further comprises citric acid or a pharmaceutically acceptable salt thereof.