US2019388386A1PendingUtilityA1

Mast cell stabilizers treatment for systemic disorders

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Assignee: RESPIVANT SCIENCES GMBHPriority: Feb 10, 2014Filed: Jul 10, 2019Published: Dec 26, 2019
Est. expiryFeb 10, 2034(~7.6 yrs left)· nominal 20-yr term from priority
Inventors:William GerhartManfred KellerAhmet TutuncuPravin Soni
A61M 15/00A61M 11/00A61M 11/041A61K 9/0075A61M 11/005A61K 31/4741A61M 2202/064A61K 31/277A61K 9/0078A61K 31/4422A61K 31/4535A61M 15/009A61K 9/12A61K 47/183A61M 11/06A61K 47/02A61P 37/08A61K 31/352H05K 999/99Y02A50/30
65
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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 an inhalation device that produces an aerosol of the pharmaceutical composition; wherein the aerosol comprises particles having an MMAD of about 4.1 μm or less and a GSD of about 1.7, as measured by USP <1601> or USP<601>. 
     
     
         2 . The method of  claim 1 , wherein the aerosol comprises particles having an MMAD of about 3.5 μm or less and a GSD of about 1.7, as measured by USP <1601> or USP<601>. 
     
     
         3 . The method of  claim 1 , wherein the inhalation device is a nebulizer. 
     
     
         4 . The method of  claim 3 , wherein the inhalation device is a high-efficiency nebulizer. 
     
     
         5 . The method of  claim 4 , wherein the nebulizer is a jet nebulizer. 
     
     
         6 . The method of  claim 4 , wherein the nebulizer is a vibrating mesh nebulizer. 
     
     
         7 . The method of  claim 1 , wherein the inhalation device is a dry-powder inhaler. 
     
     
         8 . The method of  claim 1 , wherein administration of the aerosol of the pharmaceutical composition to the patient using the inhalation device produces in the patient an AUC 0 -∞ of cromolyn between from about 5.3 ng*h/mL to about 8.5 ng*h/mL per milligram of cromolyn sodium administered to the patient. 
     
     
         9 . The method of  claim 1 , wherein administration of the aerosol of the pharmaceutical composition to the patient using the inhalation device produces in the patient a C max  of cromolyn between from about 2.2 ng/mL to about 3.9 ng/mL per milligram of cromolyn sodium administered to the patient. 
     
     
         10 . A method of administering cromolyn sodium to a patient in need thereof, comprising administering to the patient a pharmaceutical composition comprising cromolyn sodium using an inhalation device that produces an aerosol of the pharmaceutical composition;
 wherein administration of the aerosol of the pharmaceutical composition to the patient using the inhalation device produces in the patient an AUC 0 -∞ of cromolyn between from about 5.3 ng*h/mL to about 8.5 ng*h/mL per milligram of cromolyn sodium administered to the patient; and   wherein administration of the aerosol of the pharmaceutical composition to the patient using the inhalation device produces in the patient a C max  of cromolyn between from about 2.2 ng/mL to about 3.9 ng/mL per milligram of cromolyn sodium administered to the patient.   
     
     
         11 . The method of  claim 10 , wherein the aerosol of the pharmaceutical composition exhibits a respirable fraction (≤5 μm) as measured by USP <1601> or USP <601> of at least about 60%. 
     
     
         12 . The method of  claim 10 , wherein the aerosol of the pharmaceutical composition exhibits a respirable fraction (≤5 μm) as measured by USP <1601> or USP <601> of at least about 75%. 
     
     
         13 . The method of  claim 10 , wherein the aerosol of the pharmaceutical composition exhibits a respirable fraction (≤3.3 μm) as measured by USP <1601> or USP <601> of at least about 30%. 
     
     
         14 . The method of  claim 10 , wherein the inhalation device is a nebulizer. 
     
     
         15 . The method of  claim 14 , wherein the inhalation device is a high-efficiency nebulizer. 
     
     
         16 . The method of  claim 15 , wherein the nebulizer is a jet nebulizer. 
     
     
         17 . The method of  claim 15 , wherein the nebulizer is a vibrating mesh nebulizer. 
     
     
         18 . The method of  claim 10 , wherein the inhalation device is a dry-powder inhaler. 
     
     
         19 . The method of  claim 10 , wherein the aerosol comprises particles having an MMAD of about 4.1 μm or less and a GSD of about 1.7, as measured by USP <1601> or USP <601>. 
     
     
         20 . The method of  claim 10 , wherein the aerosol comprises particles having an MMAD of about 3.5 μm or less and a GSD of about 1.7, as measured by USP <1601> or USP <601>.

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