INHALABLE FORMULATION OF A SOLUTION CONTAINING GLYCOPYRROLATE AND OLODATEROL HYDROCHLORIDE
The present invention relates to a liquid 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) glycopyrrolate or a salt thereof (b) olodaterol or a salt thereof; (b) a solvent; (c) a pharmacologically acceptable preservative, and (d) a pharmacologically acceptable stabilizer, and optionally other pharmacologically acceptable additives.
1 . A liquid, propellant-free pharmaceutical preparation comprising: (a) glycopyrronium or a salt thereof (b) olodaterol or a salt thereof; (c) a solvent; (d) a pharmacologically acceptable stabilizer; and (e) a pharmacologically acceptable preservative.
2 . The pharmaceutical preparation according to claim 1 , wherein the pharmaceutical preparation has a pH in a range of from about 2.0 to about 7.5.
3 . The pharmaceutical preparation according to claim 2 , wherein the pharmaceutical preparation has a pH in a range of from about 3.0 to about 4.0.
4 . The pharmaceutical preparation according to claim 1 , wherein the olodaterol or a salt thereof is olodaterol hydrochloride and the glycopyrronium or a salt thereof is glycopyrrolate.
5 . The pharmaceutical preparation according to claim 4 , wherein the glycopyrrolate is present in an amount of from about 10 mg/100 ml to about 6 g/100 ml.
6 . The pharmaceutical preparation according to claim 4 , wherein the glycopyrrolate is present in an amount of from about 50 mg/100 ml to about 300 mg/100 ml.
7 . The pharmaceutical preparation according to claim 4 , wherein the olodaterol hydrochloride is present in an amount of from about 2.0 mg/100 ml to about 1.5 g/100 ml.
8 . The pharmaceutical preparation according to claim 4 , wherein the olodaterol hydrochloride is present in an amount of from about 10 mg/100 ml to about 50 mg/100 ml.
9 . The pharmaceutical preparation according to claim 1 , wherein the pharmacologically acceptable preservative is selected from the group consisting of benzalkonium chloride, benzoic acid, sodium benzoate, and combinations thereof.
10 . The pharmaceutical preparation according to claim 9 , wherein the preservative is present in an amount of from about 2 mg/100 ml to about 1000 mg/100 ml.
11 . The pharmaceutical preparation according to claim 1 , wherein the stabilizer is selected from the group consisting of edetic acid, edetate disodium dihydrate, edetate disodium, citric acid, and combinations thereof.
12 . The pharmaceutical preparation according to claim 1 , wherein the solvent is water.
13 . The pharmaceutical preparation according to claim 11 , wherein the stabilizer is present in an amount of from about 1 mg/100 ml to about 500 mg/100 ml.
14 . The pharmaceutical preparation according to claim 1 , wherein the pharmaceutical preparation further comprises a pharmacologically acceptable additive.
15 . A method for administering the pharmaceutical preparation according to claim 1 , comprising nebulizing a defined amount of the pharmaceutical preparation through a nozzle by the application of pressure to form an inhalable aerosol.
16 . The method of claim 15 , wherein the pharmaceutical preparation is nebulized using an inhaler device.
17 . The method according to claim 15 , wherein the defined amount of the pharmaceutical preparation is from about 5 to about 30 microliters.
18 . The method according to claim 15 , wherein the inhalable aerosol has a D50 less than about 8 μm.
19 . The method according to claim 16 , wherein the inhaler comprises a block function and a counter.
20 . A method of treating asthma or COPD in a patient, comprising administering to the patient the pharmaceutical preparation the method of claim 15 .
21 . A method of treating asthma or COPD in a patient, comprising administering to the patient a pharmaceutical preparation of claim 1 .