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 .- 7 . (canceled) 
     
     
         8 . A solid formulation comprising a therapeutically effective amount of treprostinil or a pharmaceutically acceptable salt thereof and a citrate buffer, wherein the amount of treprostinil comprises from 0.05% to 95% by weight of the composition. 
     
     
         9 . The solid formulation of  claim 8 , which is a unit-dose formulation. 
     
     
         10 . The solid formulation of  claim 9 , wherein the unit-dose formulation is a capsule. 
     
     
         11 . The solid formulation of  claim 10 , wherein the amount of treprostinil is from about 0.1 mg to about 50 mg. 
     
     
         12 . The solid formulation of  claim 10 , wherein the unit-dose formulation is prepared by mixing a powder comprising treprostinil or a pharmaceutically acceptable salt thereof and a surface active/dispersing agent.