US2019388385A1PendingUtilityA1

Methods for the treatment of mast cell related disorders with mast cell stabilizers

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Assignee: RESPIVANT SCIENCES GMBHPriority: Aug 7, 2015Filed: Jul 10, 2019Published: Dec 26, 2019
Est. expiryAug 7, 2035(~9.1 yrs left)· nominal 20-yr term from priority
A61P 37/08A61K 31/35A61K 9/0078A61K 31/352
58
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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-modified
What 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.

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