Activated protein C formulations

Abstract

The present invention relates to pharmaceutical formulations of activated protein C. The activated protein C formulations of the present invention are more stable than other formulations of activated protein C and demonstrate fewer degradation products over time.

We claim:  
     
         1 . A lyophilized formulation consisting essentially of activated protein C; a salt; a bulking agent selected from mannitol, trehalose, raffinose, and sucrose, and mixtures thereof; and a buffer system such that upon reconstitution the resulting formulation has a pH between about 5.5 and about 6.1.  
     
     
         2 . The formulation of  claim 1 , wherein the salt is potassium chloride or sodium chloride and the buffer system is selected from Tris-acetate, sodium citrate, and sodium phosphate, or mixtures thereof.  
     
     
         3 . The formulation of  claim 2 , wherein the resulting formulation has a pH between about 5.9 and about 6.1.  
     
     
         4 . The formulation of  claim 2 , wherein the resulting formulation has a pH between about 5.6 and about 6.0.  
     
     
         5 . The formulation of  claim 2 , wherein the Resulting formulation has a pH between about 5.8 and about 6.1.  
     
     
         6 . The formulation of  claim 2 , wherein the resulting formulation has a pH of about 6.0.  
     
     
         7 . A lyophilized formulation consisting of activated protein C; a salt; a bulking agent selected from mannitol, trehalose, raffinose, and sucrose, and mixtures thereof; and a buffer system such that upon reconstitution the resulting formulation has a pH between about 5.5 and about 6.0.  
     
     
         8 . The formulation of  claim 7 , wherein the salt is sodium chloride and the buffer system is selected from Tris-acetate, sodium citrate, and sodium phosphate, or mixtures thereof.  
     
     
         9 . The formulation of  claim 8 , wherein the resulting formulation has a pH between about 5.9 and about 6.1.  
     
     
         10 . The formulation of  claim 8 , wherein the resulting formulation has a pH between about 5.6 and about 6.0.  
     
     
         11 . The formulation of  claim 8 , wherein the resulting formulation has a pH between about 5.8 and about 6.1.  
     
     
         12 . The formulation of  claim 8 , wherein the buffer is sodium citrate and the resulting formulation has a pH of about 6.0.