US 12,383,516 B1
Albuterol aerosol suspension formulation for oral inhalation with high amount of green propellant hydrofluoroolefin (HFO) and free of co-solvent
Jack Yongfeng Zhang, Rancho Cucamonga, CA (US); Ying Wang, Rancho Cucamonga, CA (US); Ray Lameng Lei, Rancho Cucamonga, CA (US); and Mary Zi-ping Luo, Rancho Cucamonga, CA (US)
Assigned to Amphastar Pharmaceuticals, Inc., Rancho Cucamonga, CA (US)
Filed by Amphastar Pharmaceuticals, Inc., Rancho Cucamonga, CA (US)
Filed on Jan. 6, 2025, as Appl. No. 19/011,043.
Int. Cl. A61K 31/137 (2006.01); A61K 9/00 (2006.01); A61K 47/06 (2006.01); A61K 47/26 (2006.01); A61K 47/32 (2006.01); A61K 47/34 (2017.01)
CPC A61K 31/137 (2013.01) [A61K 9/0075 (2013.01); A61K 47/06 (2013.01); A61K 47/26 (2013.01); A61K 47/32 (2013.01); A61K 47/34 (2013.01)] 20 Claims
OG exemplary drawing
 
1. A co-solvent-free pharmaceutical aerosol formulation for use with a pressurized metered dose inhaler (MDI) comprising:
(a) a suspension formulation of pre-micronized albuterol sulfate or other pharmaceutically acceptable salt, or albuterol base thereof;
(b) a pressurized, liquefied propellant comprising a hydrofluoroolefin (HFO) present in an amount of from about 99.0% to about 99.9% (w/w) relative to the total weight of the formulation; and
(c) a surfactant in an amount not more than about 0.1% (w/w) relative to the total weight of the formulation,
wherein the formulation does not contain a co-solvent selected from the group of ethanol, glycerol, propylene glycol, and a combination thereof.