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 a device that produces an aerosol of the pharmaceutical composition exhibiting a respirable fraction (≤5 μm) of at least about 60%, and wherein administration of the pharmaceutical composition comprising from about 40 mg to about 80 mg of cromolyn sodium to the subject produces in the subject an AUC (0-∞) of the cromolyn sodium greater than about 120 ng*hr/mL.
2 . The method of claim 1 , wherein administration of the pharmaceutical composition to the subject by means of the device produces in the subject an AUC (0-∞) of the cromolyn sodium greater than about 200 ng*hr/mL.
3 . The method of claim 1 , wherein administration of the pharmaceutical composition to the subject by means of the device produces in the subject an AUC (0-∞) of the cromolyn sodium greater than about 330 ng*hr/mL.
4 . The method of claim 1 , wherein administration of the pharmaceutical composition comprising 80 mg of cromolyn sodium to the subject produces in the subject an AUC (0-∞) of the cromolyn sodium greater than about 525 ng*hr/mL.
5 . The method of claim 1 , wherein the device is a nebulizer.
6 . The method of claim 5 , wherein the nebulizer is a high-efficiency nebulizer.
7 . The method of claim 1 , wherein the device is a dry powder inhaler.
8 . The method of claim 1 , wherein the administration of the pharmaceutical composition to the subject produces in the subject a C max of the cromolyn sodium greater than about 55 ng/mL.
9 . The method of claim 8 , wherein the device is a nebulizer.
10 . The method of claim 9 , wherein the device is a high-efficiency nebulizer.
11 . The method of claim 8 , wherein the device is a dry powder inhaler.
12 . The method of claim 1 , wherein the pharmaceutical composition comprises about 40 mg of cromolyn sodium.
13 . A method of administering cromolyn sodium to a patient in need thereof, comprising administering to the patient a pharmaceutical composition comprising cromolyn sodium using a device that produces an aerosol of the pharmaceutical composition exhibiting a respirable fraction (≤5 μm) of at least about 60%, and wherein administration of the pharmaceutical composition comprising from about 40 mg to about 80 mg of cromolyn sodium to the subject produces in the subject a C max of the cromolyn sodium greater than about 55 ng/mL.
14 . The method of claim 13 , wherein administration of the pharmaceutical composition to the subject produces in the subject a C max of the cromolyn sodium greater than about 80 ng/mL.
15 . The method of claim 13 , wherein administration of the pharmaceutical composition to the subject produces in the subject a C max of the cromolyn sodium greater than about 150 ng/mL.
16 . The method of claim 13 , wherein administration of the pharmaceutical composition comprising 80 mg of cromolyn sodium to the subject produces in the subject a C max of the cromolyn sodium greater than about 120 ng/mL.
17 . The method of claim 12 , wherein administration of the pharmaceutical composition to the subject by means of the device produces in the subject an AUC (0-∞) of the cromolyn sodium greater than about 230 ng*hr/mL.
18 . The method of claim 13 , wherein the device is a nebulizer.
19 . The method of claim 18 , wherein the device is a high-efficiency nebulizer.
20 . The method of claim 13 , wherein the device is a dry powder inhaler.