Inventors:
Jianxin Gao - Norton MA, US
James Luo - Quincy MA, US
Rong Zhou - Fullerton CA, US
Mary Ziping Luo - Diamond Bar CA, US
Jack Yongfeng Zhang - Diamond Bar CA, US
Assignee:
Amphastar Pharmaceuticals Inc. - Rancho Cucamonga CA
International Classification:
A61K 31/135
A61K 31/05
A61K 9/12
A61K 9/14
US Classification:
514653, 514728, 424 45, 424 46, 424489
Abstract:
A stable suspension aerosol formulation of epinephrine is suitable for administration through inhalation comprising a therapeutically effective amount of epinephrine, hydrofluorocarbon propellant, co-solvent, surfactant, and antioxidant. The suspension aerosol formulation further comprises [pre-] pre-micronized epinephrine suspended in an alcohol/surfactant solution with hydrofluoroalkane propellant. The suspension formulation provides a highly efficient delivery of drug microparticles into the respirable region of patients' lungs and has the following advantages: lower dosage requirement, minimum alcohol content, with less impurities generated during storage, improved efficacy and safety, and exhibits no ozone depleting potential compared to a formulation containing chlorofluorocarbon.