US 12,220,525 B2
Tiotropium formulation and inhaler
Alexander D. Slowey, Bracknell (GB); Philip M. Cocks, Bracknell (GB); and Neha A. Patel, Bracknell (GB)
Assigned to Kindeva Drug Deliver L.P., Woodbury, MN (US)
Appl. No. 16/973,863
Filed by KINDEVA DRUG DELIVERY L.P., St. Paul, MN (US)
PCT Filed Jun. 26, 2019, PCT No. PCT/US2019/039133
§ 371(c)(1), (2) Date Dec. 10, 2020,
PCT Pub. No. WO2020/006017, PCT Pub. Date Jan. 2, 2020.
Claims priority of provisional application 62/690,677, filed on Jun. 27, 2018.
Prior Publication US 2021/0260310 A1, Aug. 26, 2021
Int. Cl. A61M 15/00 (2006.01); A61K 9/00 (2006.01); A61K 31/5386 (2006.01); A61K 47/10 (2017.01); A61K 47/12 (2006.01); A61K 47/24 (2006.01)
CPC A61M 15/0066 (2014.02) [A61K 9/008 (2013.01); A61K 31/5386 (2013.01); A61K 47/10 (2013.01); A61K 47/12 (2013.01); A61K 47/24 (2013.01); A61M 15/009 (2013.01); A61M 2205/02 (2013.01)] 19 Claims
OG exemplary drawing
 
1. A metered dose inhaler equipped with a metering valve and having an aerosol canister containing a pharmaceutical composition comprising:
propellant;
ethanol at a concentration of no greater than about 20 wt. %;
citric acid at a concentration of no greater than 0.07 wt. %; and
tiotropium or a pharmaceutically acceptable salt or solvate thereof dissolved in the composition;
wherein the aerosol canister has an internal surface that is a non-metal material that is in contact with the pharmaceutical composition,
wherein the pharmaceutical composition does not include water.