Nebulized imatinib formulations, manufacture, and uses thereof

Abstract

The invention relates to nebulized imatinib formulations, manufacture, and uses thereof.

What is claimed is: 
     
         1 . A method of treating pulmonary hypertension, the method comprising: providing to a subject a nebulized formulation using a vibrating mesh nebulizer, wherein the nebulized formulation comprises at least 1 mg of imatinib or a salt thereof per dose. 
     
     
         2 . The method of  claim 1  wherein the formulation comprises between about 1 mg and about 100 mg of imatinib or a salt thereof per dose. 
     
     
         3 . The method of  claim 1 , wherein the nebulized formulation comprises droplets that comprise imatinib or a salt thereof. 
     
     
         4 . The method of  claim 3 , wherein the droplets comprise a size of about 0.5 μm to about 5 μm. 
     
     
         5 . The method of  claim 1 , wherein the formulation further comprises one or more excipients. 
     
     
         6 . The method of  claim 1 , wherein the formulation comprises imatinib or a salt thereof in solution. 
     
     
         7 . The method of  claim 1 , wherein the formulation comprises imatinib or a salt thereof in a suspension. 
     
     
         8 . The method of  claim 1 , wherein the subject is a human. 
     
     
         9 . The method of  claim 1 , wherein the pulmonary hypertension being treated is pulmonary arterial hypertension (PAH). 
     
     
         10 . A kit for treating pulmonary hypertension comprising:
 one or more doses, each of the one or more doses comprising at least 1 mg of imatinib or a salt thereof; and a vibrating mesh nebulizer.   
     
     
         11 . The kit of  claim 10 , wherein the imatinib or a salt thereof is a liquid formulation of imatinib or a salt thereof. 
     
     
         12 . The kit of  claim 11 , wherein the liquid formulation is a sterile liquid formulation. 
     
     
         13 . The kit of  claim 10 , wherein the one or more doses comprise between about 1 mg and about 100 mg of imatinib or a sale thereof. 
     
     
         14 . The kit of  claim 10 , wherein the imatinib or a salt thereof is a dry composition of the imatinib or a salt thereof and the kit further comprises one or more liquids to reconstitute the imatinib or a salt thereof into a liquid formulation of the imatinib or a salt thereof. 
     
     
         15 . The kit of  claim 14 , wherein the dry composition of the imatinib or a salt thereof comprises particles of imatinib or a salt thereof. 
     
     
         16 . The kit of  claim 15  wherein the particles of imatinib or a salt thereof have been micronized. 
     
     
         17 . The kit of  claim 16 , wherein the particles comprise a size of about 0.5 to about 5 μm. 
     
     
         18 . The kit of  claim 11 , wherein the formulation further comprises one or more excipients. 
     
     
         19 . The kit of  claim 11 , wherein the nebulizer is operable to generate droplets of the liquid formulation sized between about 0.5 μm and about 5 μm. 
     
     
         20 . The kit of  claim 11 , wherein the pulmonary hypertension being treated is pulmonary arterial hypertension (PAH).