Parenteral 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 injectable formulation comprising a) a therapeutically effective amount of treprostinil or a pharmaceutically acceptable salt thereof and b) a citrate buffer. 
     
     
         2 . The formulation of  claim 1 , which is sterile and isotonic with blood. 
     
     
         3 . A method of treating pulmonary hypertension comprising parenterally administering to a subject in need thereof a formulation comprising a) a therapeutically effective amount of treprostinil or a pharmaceutically acceptable salt thereof and b) a citrate buffer. 
     
     
         4 . The method of  claim 3 , wherein the parenteral administration is performed intravenously. 
     
     
         5 . The method of  claim 3 , wherein the formulation is sterile and isotonic with a blood of the subject. 
     
     
         6 . The method of  claim 3 , wherein the formulation is administered at a rate of 0.625 to 50 ng/kg/min. 
     
     
         7 . The method of  claim 3 , wherein the formulation is administered at a rate of 10 to 15 ng/kg/min.