Liquid formulations of tumor necrosis factor-binding proteins

Abstract

The invention relates to a stable, pharmaceutically acceptable, aqueous formulation of TNF-binding protein, comprising a TNF-binding protein, a buffer and an isotonicity agent.

1 - 13 . (canceled) 
     
     
         14 . A stable, pharmaceutically acceptable, aqueous formulation, comprising:
 TNF-binding protein 2 (TPB-2),   a citrate buffer keeping the pH between 4 and 7, and   an isotonicity agent.   
     
     
         15 . The formulation according to  claim 14 , in which the buffer keeps the pH comprised between 6 and 7. 
     
     
         16 . The formulation according to  claim 14 , in which the isotonicity agent is sodium chloride. 
     
     
         17 . The formulation according to  claim 14 , in which the isotonicity is mannitol. 
     
     
         18 . The formulation according to  claim 14 , in which the concentration of TNF-binding protein 2 is between 5 and 170 mg/ml. 
     
     
         19 . The formulation according to any of the preceding  claim 14 , in which the concentration of the citrate buffer is from 5 to 150 mM. 
     
     
         20 . The formulation according to  claim 14 , in which the concentration of the isotonicity agent is from 5 to 50 mM. 
     
     
         21 . A process for the preparation of a liquid pharmaceutical formulation according to  claim 14 , said process comprising:
 diluting the TNF-binding protein with a solution of an excipient.   
     
     
         22 . A presentation form of the liquid pharmaceutical formulation according to  claim 14 , wherein said presentation form is hermetically sealed in sterile conditions in a container appropriate for storage prior to use.