US2019388385A1PendingUtilityA1
Methods for the treatment of mast cell related disorders with mast cell stabilizers
Est. expiryAug 7, 2035(~9.1 yrs left)· nominal 20-yr term from priority
A61P 37/08A61K 31/35A61K 9/0078A61K 31/352
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Claims
Abstract
Methods for the treatment of systemic mast cell related disorders treatable with mast cell stabilizers, including mast well related disorders, are provided.
Claims
exact text as granted — not AI-modifiedWhat is claimed:
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.Cited by (0)
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