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FORMOTEROL/STEROID BRONCHODILATING COMPOSITIONS AND METHODS OF USE THEREOF

  • US 20100069342A1
  • Filed: 11/24/2009
  • Published: 03/18/2010
  • Est. Priority Date: 04/17/2001
  • Status: Active Grant
First Claim
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1. A method for the treatment, or amelioration of one or more symptoms of bronchoconstrictive disorders, comprising:

  • providing a pharmaceutical composition formulated for single dosage administration, wherein;

    the composition contains;

    (i) formoterol, or a pharmaceutically acceptable salt or hydrate thereof in solution; and

    (ii) a steroidal anti-inflammatory agent, or a pharmaceutically acceptable salt or hydrate thereof in suspension;

    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 90% of the initial amount of formoterol in the compositions remains at such time; and

    the formoterol free base concentration is about 5 μ

    g/mL to about 200 μ

    g/mL, whereby the composition is formulated for direct administration to a human in need thereof; and

    without dilution, directly administering an effective amount of the composition as provided to a subject in need of such treatment.

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