Compositions, methods and 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 metered dose inhaler containing a pharmaceutically acceptable co-suspension, the co-suspension comprising;
a suspension medium comprising a pharmaceutically acceptable propellant free of co-solvents and solubilizing agents;
two or more species of respirable active agent particles, wherein a first species of active agent particles comprises respirable particles of a pharmaceutically acceptable salt, ester, isomer of glycopyrrolate, and a second species of active agent particles comprises respirable particles of a pharmaceutically acceptable salt, ester, isomer of formoterol; and
a plurality of respirable suspending particles different than the active agent particles and formed of a dry, particulate phospholipid material that is substantially insoluble in the suspension medium, wherein the suspending particles and the two or more species of active agent particles are co-suspended in the suspension medium at a weight ratio of total mass of the suspending particles to total mass of the two or more species of active agent particles that ranges from above 1;
1 and up to 200;
1; and
administering the co-suspension to the patient as a respirable aerosol produced by actuating the metered dose inhaler, wherein said administering of the co-suspension comprises delivering therapeutically effective amounts of glycopyrrolate and formoterol to the patient.
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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.
123 Citations
57 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 metered dose inhaler containing a pharmaceutically acceptable co-suspension, the co-suspension comprising; a suspension medium comprising a pharmaceutically acceptable propellant free of co-solvents and solubilizing agents; two or more species of respirable active agent particles, wherein a first species of active agent particles comprises respirable particles of a pharmaceutically acceptable salt, ester, isomer of glycopyrrolate, and a second species of active agent particles comprises respirable particles of a pharmaceutically acceptable salt, ester, isomer of formoterol; and a plurality of respirable suspending particles different than the active agent particles and formed of a dry, particulate phospholipid material that is substantially insoluble in the suspension medium, wherein the suspending particles and the two or more species of active agent particles are co-suspended in the suspension medium at a weight ratio of total mass of the suspending particles to total mass of the two or more species of active agent particles that ranges from above 1;
1 and up to 200;
1; andadministering the co-suspension to the patient as a respirable aerosol produced by actuating the metered dose inhaler, wherein said administering of the co-suspension comprises delivering therapeutically effective amounts of glycopyrrolate and formoterol to the patient. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57)
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Specification