Amphastar Pharmaceuticals, Inc.

Ray Lameng Lei

Jack Yongfeng Zhang

Mary Zi-Ping Luo

Ying Wang

Christos Lymberopoulos

Tielong Gao

Pharmaceutical aerosol formulations containing pre-micronized epinephrine, co-solvent ethanol, surfactant polysorbate 80, and propellant trans-1,3,3,3-tetrafluoropropene (HFO-1234ze(E)) for use in a pressurized metered dose inhaler is described. The formulations provide a highly efficient delivery of pre-micronized epinephrine particles into the patients' respiratory tracts and have the advantages of high efficacy, improved safety, and a low global warming potential (GWP) for environmental impact.

Stable epinephrine suspension formulation for inhalation with HFO propellant

Pharmaceutical aerosol formulations containing pre-micronized albuterol sulfate, high amount of green propellant trans-1,3,3,3-tetrafluoropropene (HFO-1234ze(E)), and a surfactant (polysorbate 80 (polyoxyethylene (20) sorbitan monooleate), polysorbate 20 (polyoxyethylene (20) sorbitan monolaurate), polyethylene glycol 1000, span 85 (sorbitan trioleate), polyvinylpyrrolidone K25, or their combination) in a pressurized metered dose inhaler are described. The formulations do not use any co-solvent, i.e., they are co-solvent-free (e.g., free of ethanol, glycerol, propylene glycol, and a combination thereof). The formulations provide highly efficient delivery, through metered dose inhaler (MDI), of pre-micronized albuterol particles into the patients' respiratory tracts and have the advantages of high efficacy, improved safety, and a low global warming potential (GWP) for environmental impact.

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Rancho Cucamonga, CA, United States of America

Ray Lameng Lei