INHALABLE FORMULATION OF A SOLUTION CONTAINING LEVALBUTEROL TARTRATE
The present invention discloses a liquid pharmaceutical preparation and a method for administering a pharmaceutical preparation by nebulizing the pharmaceutical preparation in an inhaler. The propellant-free pharmaceutical preparation comprises: (a) active levalbuterol or a salt thereof, such as levalbuterol tartrate; (b) a pharmacologically acceptable preservative; (c) a pharmacologically acceptable stabilizer, (d) a solvent, and optionally (e) other pharmacologically acceptable additives.
1 . A liquid, propellant-free pharmaceutical formulation comprising: (a) levalbuterol or a salt thereof; (b) water; (c) a pharmacologically acceptable stabilizer; and (d) a pharmacologically acceptable preservative, wherein the formulation is suitable for administration using a soft mist inhaler.
2 . The pharmaceutical formulation of claim 1 comprising levalbuterol tartrate.
3 . The pharmaceutical formulation of claim 2 , wherein levalbuterol tartrate is present in an amount ranging from about 20 mg/100 g to about 10 g/100 g.
4 . The pharmaceutical formulation of claim 2 , wherein levalbuterol tartrate is present in an amount ranging from about 200 mg/100 g to about 500 mg/100 g.
5 . The pharmaceutical formulation of claim 1 , wherein the pharmacologically acceptable preservative is selected from the group consisting of benzalkonium chloride, benzoic acid, sodium benzoate, and a combination thereof.
6 . The pharmaceutical formulation of claim 5 , wherein the preservative is present in an amount ranging from about 2 mg/100 g to about 1000 mg/100 g.
7 . The pharmaceutical formulation of claim 1 , wherein the stabilizer is selected from the group consisting of edetic acid, edetate disodium dehydrate, edetate disodium, citric acid, and any combination thereof.
8 . The pharmaceutical formulation of claim 6 , wherein the stabilizer is present in an amount ranging from about 1 mg/100 g to about 500 mg/100 g.
9 . The pharmaceutical formulation of claim 1 , comprising a pharmacologically acceptable additive.
10 . The pharmaceutical formulation of claim 1 , wherein the pharmaceutical formulation has a pH in a range from about 3.0 to about 5.0.
11 . A method for administering the pharmaceutical formulation of claim 1 to a patient, comprising forming an inhalable aerosol by using pressure to force a defined amount of the pharmaceutical formulation through a nozzle to nebulize the pharmaceutical formulation.
12 . The method of claim 11 , wherein the defined amount of the pharmaceutical formulation ranges from about 5 to about 30 microliters.
13 . The method formulation of claim 11 , wherein the inhalable aerosol has an aerosol D50 of less than about 5 μm.
14 . The method of claim 11 , wherein the pharmaceutical formulation is administered using an inhaler comprising a blocking function and a counter.
15 . A method of treating asthma or COPD in a patient, comprising administering to the patient the pharmaceutical formulation of claim 1 .
16 . A method of treating asthma or COPD in a patient, comprising administering to the patient the pharmaceutical formulation of claim 2 .
17 . A method for administering the pharmaceutical formulation of claim 1 to a patient, comprising nebulizing the pharmaceutical formulation in an inhaler, wherein the inhaler includes a blocking function and a counter.
18 . The method of claim 11 , wherein the patient has asthma or COPD.
19 . A device for administering levalbuterol or a salt thereof comprising:
(a) a soft mist inhaler and
(b) a liquid, propellant-free pharmaceutical formulation comprising:
(i) levalbuterol tartrate or a salt thereof present in an amount between about 200 mg/100 g to about 500 mg/100 g;
(ii) water;
(iii) a pharmacologically acceptable stabilizer; and
(iv) a pharmacologically acceptable preservative,
wherein the pharmaceutical formulation has a pH in a range from about 3.0 to about 5.0, and
wherein the formulation is contained in the soft mist inhaler.