METERED DOSE INHALERS AND SUSPENSION COMPOSITIONS

1 . A metered dose inhaler comprising:

a metering valve;

a canister; and

an actuator comprising an actuator nozzle;

wherein the canister comprises a formulation, the formulation comprising:

greater than 70% by weight of propellant HFO-1234ze(E);

ethanol; and

at least one active pharmaceutical ingredient suspended in the formulation to form a suspension.

2 . The inhaler of claim 1 , wherein the active pharmaceutical ingredient is selected from beta agonists (short- or long-acting beta agonists), corticosteroids, anticholinergic agents, TYK Inhibitors, and combinations thereof.

3 . The inhaler of claim 2 , wherein the corticosteroid is selected from beclomethasone, budesonide, mometasone, ciclesonide, flunisolide, and fluticasone.

4 . The inhaler of claim 2 , wherein the anticholinergic agent is selected from ipratropium, tiotropium, aclidinium, umeclidinium, and glycopyrronium.

5 . The inhaler of claim 2 , wherein the beta agonist (short or long-acting beta agonist) is selected from salbutamol, levalbuterol, salmeterol, formoterol, indacaterol, olodaterol, vilanterol, and abediterol.

6 . The inhaler of claim 1 , wherein the formulation comprises at least two active pharmaceutical ingredients.

7 . A metered dose inhaler comprising:

a metering valve;

a canister; and

an actuator comprising an actuator nozzle;

wherein the canister comprises a formulation, the formulation comprising:

a propellant comprising HFO-1234ze(E);

ethanol; and

an active pharmaceutical ingredient comprising fluticasone or a pharmaceutically acceptable salt or ester thereof, wherein the fluticasone or pharmaceutically acceptable salt or ester thereof is suspended in the formulation to form a suspension.

8 . A metered dose inhaler comprising:

a metering valve;

a canister; and

an actuator comprising an actuator nozzle;

wherein the canister comprises a formulation, the formulation comprising:

a propellant comprising HFO-1234ze(E);

ethanol; and

an active pharmaceutical ingredient comprising salbutamol or a pharmaceutically acceptable salt or ester thereof, wherein the salbutamol or pharmaceutically acceptable salt or ester thereof is suspended in the formulation to form a suspension.

9 . A metered dose inhaler comprising:

a metering valve;

a canister; and

an actuator comprising an actuator nozzle;

wherein the canister comprises a formulation, the formulation comprising:

a propellant comprising HFO-1234ze(E);

ethanol; and

an active pharmaceutical ingredient comprising mometasone or a pharmaceutically acceptable salt or ester thereof, wherein the mometasone or pharmaceutically acceptable salt or ester thereof is suspended in the formulation to form a suspension.

10 . The inhaler of claim 1 , wherein the amount of ethanol by weight of the total formulation is between 0.2% and 15%.

11 . The inhaler of claim 10 , wherein the amount of ethanol by weight of the total formulation is between 2% and 5%.

12 . The inhaler of claim 1 , wherein the formulation comprises the active pharmaceutical ingredient to deliver an amount greater than 0.001 mg/actuation.

13 . The inhaler of claim 12 , wherein the formulation comprises the active pharmaceutical ingredient to deliver an amount less than 0.5 mg/actuation.

14 . The inhaler of claim 1 , wherein HFO-1234ze(E) is the sole propellant.

15 . The inhaler of claim 1 , wherein the propellant comprises HFO-1234ze(E) and another hydrofluroroolefin or a hydrofluoroalkane.

16 . The inhaler of claim 15 , wherein the formulation includes a hydrofluoroalkane in an amount of 10% to 20% by weight, of the formulation.

17 . The inhaler of claim 1 , wherein the formulation further comprises a surfactant.

18 . The inhaler of claim 17 , wherein the surfactant is selected from oleic acid, sorbitan monooleate, sorbitan trioleate, soya lecithin, polyethylene glycol, polyvinylpyrrolidone, and a combination thereof.

19 . The inhaler of claim 1 , wherein the metering valve comprises a metering chamber having a size between 25 microliters and 200 microliters.

20 . The inhaler of claim 1 , wherein the amount of HFO-1234ze(E) by weight of the total propellant in the formulation is greater than 95%.