Inhalable Formulation of a Solution Containing Olodaterol
The present invention relates to a liquid, propellant-free pharmaceutical preparation and a method for administering the pharmaceutical preparation by nebulizing the pharmaceutical preparation in an inhaler. The propellant-free pharmaceutical preparation comprises: (a) Olodaterol; (b) a solvent; (c) an isoosmotic adjusting agent; (d) a pH adjusting agent, and optionally including other pharmacologically acceptable additives.
1 . A propellant-free inhalation formulation comprising Olodaterol, or a pharmaceutically acceptable salt thereof, a pH adjusting agent, optionally including a pharmacologically acceptable additive, dissolved in a solvent.
2 . The formulation of claim 1 , wherein the pharmaceutically acceptable salt is Olodaterol hydrochloride.
3 . The formulation of claim 2 , wherein Olodaterol hydrochloride is present in an amount ranging from about 182 mcg/100 ml to about 182 mg/100 ml.
4 . The formulation of claim 1 , comprising a pharmacologically acceptable additive, wherein the pharmacologically acceptable additive is an isosmotic adjusting agent selected from the group consisting of sodium chloride, glucose, mannitol, glucitol, and mixtures thereof.
5 . The formulation of claim 4 , wherein the isosmotic adjusting agent is present in an amount ranting from about 0.8% (w/w) to about 1% (w/w).
6 . The formulation of claim 1 , wherein the solvent is water.
7 . The formulation of claim 1 , wherein the pH adjusting agent is selected from the group consisting of citric acid-citrate, citric acid, hydrochloric acid, and sodium hydroxide.
8 . The formulation of claim 1 , wherein the formulation has a pH ranging from about 1.0 to about 6.0.
9 . The formulation of claim 1 , wherein the formulation has a pH ranging from about 2.8 to about 4.3.
10 . The formulation of claim 1 , wherein the pharmacologically acceptable additive is selected from the group consisting of edetic acid, edetate disodium dehydrate, edetate disodium, citric acid, and combinations thereof.
11 . The formulation of claim 1 , comprising a pharmacologically acceptable additive, wherein the pharmacologically acceptable additive is selected from the group consisting of benzalkonium chloride, benzoic acid, sodium benzoate, and combinations thereof.
12 . The formulation of claim 1 , comprising a pharmacologically acceptable additive, wherein the pharmacologically acceptable additive is present in an amount ranging from about 1 mg/100 ml to about 500 mg/100 ml.
13 . The formulation according to claim 1 , wherein the formulation has osmotic pressure ranging from about 100 mOsm to about 400 mOsm.
14 . A method of treating asthma or COPD in a patient, comprising administering to the patient a therapeutically effective amount of the pharmaceutical preparation according to claim 1 by inhalation.
15 . The method of claim 14 , wherein the pharmaceutically acceptable salt is Olodaterol hydrochloride, and the Olodaterol hydrochloride is administered at a dose ranging from about 3 μg to about 80 μg.
16 . The method of claim 15 , wherein the Olodaterol hydrochloride is administered at a dose ranging from about 5 μg to about 30 μg.
17 . The method of claim 14 , wherein the pharmaceutical formulation is administered using a nebulization inhalation device to provide an inhalable aerosol of the pharmaceutical formulation.
18 . The method of claim 16 , wherein the inhalable aerosol has a D50 that is less than about 10 μm.
19 . The method of claim 17 , wherein the inhalable aerosol has an average particle size of less than about 15 microns.