US2019307721A1PendingUtilityA1

Mast cell stabilizers treatment for systemic disorders

75
Assignee: RESPIVANT SCIENCES GMBHPriority: Feb 10, 2014Filed: May 7, 2019Published: Oct 10, 2019
Est. expiryFeb 10, 2034(~7.6 yrs left)· nominal 20-yr term from priority
Inventors:William GerhartManfred KellerAhmet TutuncuPravin Soni
A61K 47/183A61K 31/277A61M 15/009A61M 11/00A61K 31/4741A61K 9/12A61K 31/4422A61K 9/0075A61M 2202/064A61M 15/00A61M 11/041A61M 11/005A61K 9/0078A61K 31/4535A61P 37/08A61M 11/06A61K 47/02A61K 31/352Y02A50/30
75
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Claims

Abstract

Methods for the treatment of systemic disorders treatable with mast cell stabilizers, including mast cell related disorders, are provided.

Claims

exact text as granted — not AI-modified
What is claimed: 
     
         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.

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