COMPOSITIONS, METHODS & SYSTEMS FOR RESPIRATORY DELIVERY OF TWO OR MORE ACTIVE AGENTS
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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Abstract
Compositions, methods and systems are provided for pulmonary or nasal delivery of two or more active agents via a metered dose inhaler. In one embodiment, the compositions include a suspension medium, active agent particles, and suspending particles, in which the active agent particles and suspending particles form a co-suspension within the suspension medium.
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Citations
30 Claims
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1. A method for treating a pulmonary disease or disorder in a patient, the method comprising:
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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; anda 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. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 20, 21, 22)
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12. A method for respiratory delivery of a therapeutically effective amount of at least two active agents to a patient, the method comprising:
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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 plurality 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; anda plurality of respirable suspending particles, wherein the plurality of respirable suspending particles and the plurality of respirable active agent particles associate with the plurality of suspending particles to form a co-suspension; and actuating the metered dose inhaler to deliver each of the active agents from the metered dose inhaler in respirable form at a DDU of ±
30%, or better, throughout emptying of the canister. - View Dependent Claims (13, 14, 15, 16, 17, 18, 19, 23, 24, 25, 26, 27, 28, 29, 30)
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Specification