FORMOTEROL/STEROID BRONCHODILATING COMPOSITIONS AND METHODS OF USE THEREOF

摘要

Bronchodilating compositions and methods are provided. The compositions are intended for administration as a nebulized aerosol. In certain embodiments, the compositions contain formoterol, or a derivative thereof, and a steroidal anti-inflammatory agent. Methods for treatment, prevention, or amelioration of one or more symptoms of bronchoconstrictive disorders using the compositions provided herein are also provided.

主权项

1. A method for treating or ameliorating one or more symptoms of a bronchoconstrictive disorder comprising: providing a pharmaceutical composition packaged for single dosage administration, the composition including (i) formoterol, or a pharmaceutically acceptable salt or hydrate thereof in solution; and (ii) a steroidal anti-inflammatory agent, or a pharmaceutically acceptable salt thereof in solution; in a pharmacologically suitable fluid comprising water that is propellant-free; the composition as formulated has an estimated shelf-life of greater than 1 month usage time at 25° C. and greater than or equal to 1 year storage time when stored at 5° C., whereby greater than 80% of the initial amount of formoterol in the compositions remains at such time; and the formoterol free base concentration is about 5 μg/mL to about 118 μg/mL, whereby the composition is formulated for direct administration to a subject in need thereof; and without dilution, directly administering an effective amount of the composition as provided to a subject in need of such treatment.