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Formoterol/steroid bronchodilating compositions and methods of use thereof

  • US 8,623,851 B2
  • Filed: 11/24/2009
  • Issued: 01/07/2014
  • Est. Priority Date: 04/17/2001
  • Status: Expired due to Term
First Claim
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1. A method for treating or ameliorting 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 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 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.

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