METHODS FOR THE TREATMENT OF MAST CELL RELATED DISORDERS WITH MAST CELL STABILIZERS
Methods for the treatment of systemic mast cell related disorders treatable with mast cell stabilizers, including mast well related disorders, are provided.
1 . A method of treating a subject having bronchopulmonary dysplasia, comprising administering to the subject an effective amount of a composition comprising cromolyn, or a salt thereof, using an inhalation device that produces droplets having an MMAD of about 4.1 μm or less and a GSD of about 1.7; wherein the subject is an infant.
2 . The method of claim 1 , wherein the inhalation device produces droplets having an MMAD of about 3.5 μm or less and a GSD of about 1.7.
3 . The method of claim 1 , wherein administration of the composition to the subject produces in the subject an AUC(0-∞) of cromolyn of from about 5.3 ng*h/mL to about 8.5 ng*h/mL per milligram of cromolyn administered to the subject.
4 . The method of claim 1 , wherein administration of the composition to the subject produces in the subject a C max of cromolyn of from about 2.2 ng/mL to about 3.9 ng/mL per milligram of cromolyn administered to the subject.
5 . The method of claim 1 , wherein the inhalation device is selected from nebulizers, metered dose inhalers, dry powder inhalers, jet nebulizers, ultrasonic wave nebulizers, heat vaporizers, and soft mist inhalers.
6 . The method of claim 5 , wherein the inhalation device is a nebulizer.
7 . The method of claim 6 , wherein the nebulizer is a high-efficiency nebulizer.
8 . The method of claim 7 , wherein the inhalation device is a vibrating mesh nebulizer.
9 . The method of claim 2 , wherein administration of the composition to the subject produces in the subject an AUC(0-∞) of cromolyn of from about 5.3 ng*h/mL to about 8.5 ng*h/mL per milligram of cromolyn administered to the subject.
10 . The method of claim 2 , wherein administration of the composition to the subject produces in the subject a C max of cromolyn of from about 2.2 ng/mL to about 3.9 ng/mL per milligram of cromolyn administered to the subject.
11 . The method of claim 2 , wherein the inhalation device is selected from nebulizers, metered dose inhalers, dry powder inhalers, jet nebulizers, ultrasonic wave nebulizers, heat vaporizers, and soft mist inhalers.
12 . The method of claim 11 , wherein the inhalation device is a nebulizer.
13 . The method of claim 12 , wherein the nebulizer is a high-efficiency nebulizer.
14 . The method of claim 13 , wherein the inhalation device is a vibrating mesh nebulizer.
15 . The method of claim 1 , wherein the salt of cromolyn is cromolyn sodium.
16 . A method of treating a subject having bronchopulmonary dysplasia, comprising administering to the subject an effective amount of a composition comprising cromolyn, or a salt thereof, using an inhalation device that produces a RF (≤3.3 μm) is at least about 30%; wherein the subject is an infant.
17 . The method of claim 1 , wherein the inhalation device produces a RF (≤5 μm) is at least about 65%.
18 . The method of claim 16 , wherein administration of the composition to the subject produces in the subject an AUC(0-∞) of cromolyn of from about 5.3 ng*h/mL to about 8.5 ng*h/mL per milligram of cromolyn administered to the subject.
19 . The method of claim 16 , wherein administration of the composition to the subject produces in the subject a C max of cromolyn of from about 2.2 ng/mL to about 3.9 ng/mL per milligram of cromolyn administered to the subject.
20 . The method of claim 16 , wherein the inhalation device is selected from nebulizers, metered dose inhalers, dry powder inhalers, jet nebulizers, ultrasonic wave nebulizers, heat vaporizers, and soft mist inhalers.
21 . The method of claim 20 , wherein the inhalation device is a nebulizer.
22 . The method of claim 21 , wherein the nebulizer is a high-efficiency nebulizer.
23 . The method of claim 22 , wherein the inhalation device is a vibrating mesh nebulizer.
24 . The method of claim 17 , wherein administration of the composition to the subject produces in the subject an AUC(0-∞) of cromolyn of from about 5.3 ng*h/mL to about 8.5 ng*h/mL per milligram of cromolyn administered to the subject.
25 . The method of claim 17 , wherein administration of the composition to the subject produces in the subject a C max of cromolyn of from about 2.2 ng/mL to about 3.9 ng/mL per milligram of cromolyn administered to the subject.
26 . The method of claim 17 , wherein the inhalation device is selected from nebulizers, metered dose inhalers, dry powder inhalers, jet nebulizers, ultrasonic wave nebulizers, heat vaporizers, and soft mist inhalers.
27 . The method of claim 26 , wherein the inhalation device is a nebulizer.
28 . The method of claim 27 , wherein the nebulizer is a high-efficiency nebulizer.
29 . The method of claim 28 , wherein the inhalation device is a vibrating mesh nebulizer.
30 . The method of claim 16 , wherein the salt of cromolyn is cromolyn sodium.