Compositions, methods & systems for respiratory delivery of two or more active agents

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 free of additional constituents;
• a first species of respirable active agent particles comprising a pharmaceutically acceptable salt, ester, or isomer of glycopyrrolate in crystalline form, as a first active agent;
• one or more additional species of respirable active agent particles comprising one or more additional active agents selected from the group consisting of a short-acting beta agonist, a long-acting and ultra long-acting β2 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, the plurality of suspending particles are formed of a material that is substantially insoluble in the suspension medium, and the active agent particles co-locate with the plurality of suspending particles to form a co-suspension;
• and
• administering a therapeutically effective amount of glycopyrrolate and the one or more additional species of active agents to the patient, wherein said administering comprises delivering the co-suspension to the patient by actuating the metered dose inhaler.

A method for respiratory delivery of a therapeutically effective amount of at least two active agents to 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 free of additional constituents;
• a plurality of respirable active agent particles comprising a pharmaceutically acceptable salt, ester or isomer of glycopyrrolate in crystalline form, as a first active agent;
• one or more additional species of respirable active agent particles comprising one or more additional active agents selected from the group consisting of a short-acting beta agonist, a long-acting and ultra long-acting (32 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 plurality of respirable suspending particles are formed of a dry particulate phospholipid material that is substantially insoluble in the suspension medium and the plurality of respirable active agent particles associate with the plurality of suspending particles to form a co-suspension;
• and
• administering a therapeutically effective amount of glycopyrrolate and the one or more additional species of active agents to the patient, wherein said administering comprises delivering the co-suspension to the patient by actuating the metered dose inhaler.