MAST CELL STABILIZERS TREATMENT FOR SYSTEMIC DISORDERS
Methods for the treatment of systemic disorders treatable with mast cell stabilizers, including mast cell related disorders, are provided.
1 . A method of administering cromolyn sodium to a patient in need thereof, comprising administering to the patient a pharmaceutical composition comprising cromolyn sodium using an inhalation device that produces an aerosol of the pharmaceutical composition; wherein the aerosol comprises particles having an MMAD of about 4.1 μm or less and a GSD of about 1.7, as measured by USP <1601> or USP<601>.
2 . The method of claim 1 , wherein the aerosol comprises particles having an MMAD of about 3.5 μm or less and a GSD of about 1.7, as measured by USP <1601> or USP<601>.
3 . The method of claim 1 , wherein the inhalation device is a nebulizer.
4 . The method of claim 3 , wherein the inhalation device is a high-efficiency nebulizer.
5 . The method of claim 4 , wherein the nebulizer is a jet nebulizer.
6 . The method of claim 4 , wherein the nebulizer is a vibrating mesh nebulizer.
7 . The method of claim 1 , wherein the inhalation device is a dry-powder inhaler.
8 . The method of claim 1 , wherein administration of the aerosol of the pharmaceutical composition to the patient using the inhalation device produces in the patient an AUC 0 -∞ of cromolyn between from about 5.3 ng*h/mL to about 8.5 ng*h/mL per milligram of cromolyn sodium administered to the patient.
9 . The method of claim 1 , wherein administration of the aerosol of the pharmaceutical composition to the patient using the inhalation device produces in the patient a C max of cromolyn between from about 2.2 ng/mL to about 3.9 ng/mL per milligram of cromolyn sodium administered to the patient.
10 . A method of administering cromolyn sodium to a patient in need thereof, comprising administering to the patient a pharmaceutical composition comprising cromolyn sodium using an inhalation device that produces an aerosol of the pharmaceutical composition;
wherein administration of the aerosol of the pharmaceutical composition to the patient using the inhalation device produces in the patient an AUC 0 -∞ of cromolyn between from about 5.3 ng*h/mL to about 8.5 ng*h/mL per milligram of cromolyn sodium administered to the patient; and
wherein administration of the aerosol of the pharmaceutical composition to the patient using the inhalation device produces in the patient a C max of cromolyn between from about 2.2 ng/mL to about 3.9 ng/mL per milligram of cromolyn sodium administered to the patient.
11 . The method of claim 10 , wherein the aerosol of the pharmaceutical composition exhibits a respirable fraction (≤5 μm) as measured by USP <1601> or USP <601> of at least about 60%.
12 . The method of claim 10 , wherein the aerosol of the pharmaceutical composition exhibits a respirable fraction (≤5 μm) as measured by USP <1601> or USP <601> of at least about 75%.
13 . The method of claim 10 , wherein the aerosol of the pharmaceutical composition exhibits a respirable fraction (≤3.3 μm) as measured by USP <1601> or USP <601> of at least about 30%.
14 . The method of claim 10 , wherein the inhalation device is a nebulizer.
15 . The method of claim 14 , wherein the inhalation device is a high-efficiency nebulizer.
16 . The method of claim 15 , wherein the nebulizer is a jet nebulizer.
17 . The method of claim 15 , wherein the nebulizer is a vibrating mesh nebulizer.
18 . The method of claim 10 , wherein the inhalation device is a dry-powder inhaler.
19 . The method of claim 10 , wherein the aerosol comprises particles having an MMAD of about 4.1 μm or less and a GSD of about 1.7, as measured by USP <1601> or USP <601>.
20 . The method of claim 10 , wherein the aerosol comprises particles having an MMAD of about 3.5 μm or less and a GSD of about 1.7, as measured by USP <1601> or USP <601>.