Claims for Patent: 11,000,517

Summary for Patent: 11,000,517

Title:	Dosage and formulation
Abstract:	The present disclosure relates to pharmaceutical compositions for inhalation comprising aclidinium in the form of a dry powder of a pharmaceutically acceptable salt in admixture with a pharmaceutically acceptable dry powder carrier, providing a metered nominal dose of aclidinium equivalent to about 400 micrograms aclidinium bromide.
Inventor(s):	Casado; Rosa Lamarca (Barcelona, ES), Serra; Gonzalo De Miquel (Barcelona, ES)
Assignee:	Almirall, S.A. (Barcelona, ES)
Application Number:	16/019,855
Patent Claims:	1. A pharmaceutical composition comprising aclidinium bromide in admixture with a pharmaceutically acceptable dry powder carrier, wherein the pharmaceutical composition is in a dosage form which provides a) a metered nominal dose of 400 micrograms plus/minus 10% aclidinium bromide and b) an emitted dose of 360 micrograms plus/minus 35% aclidinium bromide, wherein the pharmaceutical composition is for inhalation. 2. The pharmaceutical composition according to claim 1, in the form of a single-dose dry powder formulation comprising a) a single metered nominal dose of 400 micrograms plus/minus 10% aclidinium bromide and b) a single emitted dose of 360 micrograms plus/minus 35% aclidinium bromide. 3. The pharmaceutical composition according to claim 1, in the form of a multi-dose dry powder formulation for administration in a multidose dry powder inhaler device calibrated to provide a metered nominal dose of 400 micrograms plus/minus 10% aclidinium bromide and b) an emitted dose of 360 micrograms plus/minus 35% aclidinium bromide. 4. The pharmaceutical composition according to claim 1, wherein the emitted dose is 360 micrograms plus/minus 10% aclidinium bromide. 5. The pharmaceutical composition according to claim 1, wherein the dosage form provides a fine particle dose of 120 micrograms plus/minus 35% aclidinium bromide. 6. The pharmaceutical composition according to claim 1, wherein the pharmaceutically acceptable carrier is lactose particles. 7. The pharmaceutical composition according to claim 1, wherein the ratio of aclidinium to carrier ranges from 1:25 to 1:75 by weight. 8. The pharmaceutical composition according to claim 7, wherein the ratio of aclidinium to carrier ranges from 1:50 to 1:75 by weight. 9. The pharmaceutical composition according to claim 7, wherein the average particle diameter of aclidinium bromide ranges from 2 .mu.m to 5 .mu.m. 10. The pharmaceutical composition according to claim 1, wherein the carrier comprises particles having a d10 ranging from 90 .mu.m to 160 .mu.m, a d50 ranging from 170 .mu.m to 270 .mu.m, and a d90 ranging from 290 .mu.m to 400 .mu.m. 11. The pharmaceutical composition according to claim 1, further comprising an effective amount of a .beta.2-agonist. 12. The pharmaceutical composition according to claim 1, wherein the .beta.2-agonist is formoterol or a pharmaceutically acceptable salt thereof. 13. The pharmaceutical composition according to claim 12, wherein the formoterol is formoterol fumarate in an amount ranging from about 5 micrograms to 25 micrograms per metered nominal dose. 14. The pharmaceutical composition according to claim 13, wherein the formoterol fumarate is present in an amount of about 12 micrograms per metered nominal dose. 15. A method of treating a respiratory condition chosen from asthma and chronic obstructive pulmonary disease, comprising administering a pharmaceutical composition comprising aclidinium bromide in admixture with a pharmaceutically acceptable dry powder carrier, wherein the pharmaceutical composition is in a dosage form which provides a) a metered nominal dose of 400 micrograms plus/minus 10% aclidinium bromide and b) an emitted dose of 360 micrograms plus/minus 35% aclidinium bromide, by inhalation to a patient in need of such treatment. 16. The method of claim 15, wherein the emitted dose is 360 micrograms plus/minus 10% aclidinium bromide. 17. The method of claim 15, wherein the dosage form provides a fine particle dose of 120 micrograms plus/minus 35% aclidinium bromide. 18. The method of claim 15, further comprising administering an effective amount of a .beta.2-agonist. 19. The method of claim 18, wherein the .beta.2-agonist is formoterol or a pharmaceutically acceptable salt thereof. 20. The method according to claim 18, wherein the .beta.2-agonist is formoterol fumarate in an amount ranging from about 5 micrograms to 25 micrograms per metered nominal dose. 21. The method according to claim 20, wherein the formoterol fumarate is present in an amount of about 12 micrograms per metered nominal dose. 22. The method according to claim 15, wherein the pharmaceutical composition is administered twice-daily. 23. A multidose dry powder inhaler device comprising a pharmaceutical composition comprising aclidinium bromide in admixture with a pharmaceutically acceptable dry powder carrier, wherein the pharmaceutical composition is in a dosage form which provides a) a metered nominal dose of 400 micrograms plus/minus 10% aclidinium bromide and b) an emitted dose of 360 micrograms plus/minus 35% aclidinium bromide. 24. The multidose dry powder inhaler device according to claim 23, wherein the emitted dose is 360 micrograms plus/minus 10% aclidinium bromide. 25. The multidose dry powder inhaler device according to claim 23, wherein the dosage form provides a fine particle dose of 120 micrograms plus/minus 35% aclidinium bromide. 26. The multidose dry powder inhaler device according to claim 23, wherein the pharmaceutical composition further comprises a .beta.2-agonist. 27. The multidose dry powder inhaler device according to claim 26, wherein the .beta.2-agonist is formoterol or a pharmaceutically acceptable salt thereof. 28. The multidose dry powder inhaler device according to claim 27, wherein the .beta.2-agonist is formoterol fumarate in an amount ranging from about 5 micrograms to 25 micrograms per metered nominal dose. 29. The multidose dry powder inhaler device according to claim 28, wherein the formoterol fumarate is present in an amount of about 12 micrograms per metered nominal dose.