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COMPOSITIONS, METHODS & SYSTEMS FOR RESPIRATORY DELIVERY OF TWO OR MORE ACTIVE AGENTS

  • US 20120039817A1
  • Filed: 10/26/2011
  • Published: 02/16/2012
  • Est. Priority Date: 05/29/2009
  • Status: Active Grant
First Claim
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1. A method for treating a pulmonary disease or disorder in a patient, the method comprising:

  • providing a metered dose inhaler comprising a canister containing a pharmaceutically acceptable co-suspension, the co-suspension comprising;

    a suspension medium comprising a pharmaceutically acceptable propellant substantially free of additional constituents;

    a first species of respirable active agent particles comprising a first active agent, wherein the first active agent is substantially crystalline glycopyrrolate, including pharmaceutically acceptable salts, esters, isomers or solvates thereof;

    one or more additional species of respirable active agent particles comprising one or more additional active agents selected from a short-acting beta agonist, a long-acting and ultra long-acting β

    2 adrenergic receptor agonist (LABA), a corticosteroid, an anti-inflammatory, an anti-tussive, a bronchodilator, and a muscarinic antagonist; and

    a plurality of respirable suspending particles, wherein the total mass of the respirable suspending particles exceeds the total mass of the respirable active agent particles and the active agent particles associate with the plurality of suspending particles to form a co-suspension; and

    administering the co-suspension to the patient by actuating the metered dose inhaler, wherein said administering of the co-suspension comprises delivering a dose of 150 μ

    g, or less, of glycopyrrolate per actuation of the metered dose inhaler and said delivery results in a clinically significant increase in FEV1 in 0.5 hours, or less, and the increase in FEV1 remains clinically significant for up to 12 hours or more.

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