Inhalation formulations of treprostinil

Abstract

The present invention describes novel methods for using Treprostinil or its derivative, or a pharmaceutically acceptable salt thereof, for the treatment and/or prevention of ischemic lesions, such as digital ulcers, in subjects with scleroderma (including systemic sclerosis), Buerger's disease, Raynaud's disease, Raynaud's phenomenon and/or other conditions that cause such lesions. The invention also relates to kits for treatment and/or prevention of ischemic lesions, comprising an effective amount of Treprostinil or its derivative, or a pharmaceutically acceptable salt thereof.

1 . An inhalation formulation comprising a pharmaceutically effective amount of treprostinil sodium and a carrier suitable for administration with a nebulizer, wherein the formulation is in a solution form. 
   
   
       2 . The inhalation formulation of  claim 1 , which is prepared by combining treprostinil sodium, sodium citrate, citric acid, hydrochloric acid, sodium hydroxide, sterile saline, and water for injection. 
   
   
       3 . The inhalation formulation of  claim 2 , wherein the pH is about 7.3. 
   
   
       4 . A method of treating pulmonary hypertension comprising administering by inhalation to a subject in need thereof an inhalation formulation as claimed in  claim 1 . 
   
   
       5 . A method of treating an ischemic lesion, comprising administering by inhalation to a subject in need thereof an inhalation formulation as claimed in  claim 1 .