Albuterol aerosol suspension formulation for oral inhalation with high amount of green propellant hydrofluoroolefin (HFO) and free of co-solvent

A pressurized metered dose inhaler comprising a co-solvent-free pharmaceutical aerosol formulation, wherein the co-solvent-free pharmaceutical aerosol formulation comprises:

• (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 any co-solvent.

A pressurized metered dose inhaler comprising a canister filled with a co-solvent-free pharmaceutical aerosol formulation, a valve, an actuator having a mouthpiece, and a dose indicator, wherein the co-solvent-free pharmaceutical aerosol formulation comprises:

• (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 any co-solvent.

A pressurized metered dose inhaler comprising a canister filled with a co-solvent-free pharmaceutical aerosol formulation, a valve, an actuator having a mouthpiece, and a dose indicator, wherein the co-solvent-free pharmaceutical aerosol formulation comprises:

• (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.