Liquid Pharmaceutical Composition Comprising an Anti-IL-6 Receptor Antibody

Abstract

The present invention relates to a novel protein formulation. In particular, the invention relates to a liquid pharmaceutical composition of an antibody directed to Interleukin-6 receptor, a method of manufacturing the composition, a kit including the composition, a package including the composition and to methods of treatment using the composition and/or package.

1 . A liquid pharmaceutical composition comprising:
 (a) an anti-IL-6 receptor (anti-IL-6R) antibody;   (b) an histidine buffer;   (c) a polyol;   (d) a free amino acid;   (e) a surfactant;   (f) water for injection; and   (g) optionally a salt.   
       wherein the composition has a pH between 5.5 and 7.5. 
     
     
         2 . The liquid pharmaceutical according to  claim 1 , wherein the composition has a pH between 6.0 and 6.5. 
     
     
         3 . The liquid pharmaceutical composition according to  claim 1 , wherein the polyol is mannitol. 
     
     
         4 . The liquid pharmaceutical composition according to  claim 1 , wherein the free amino acid is methionine. 
     
     
         5 . The liquid pharmaceutical composition according to  claim 1 , wherein the surfactant is a polysorbate. 
     
     
         6 . The liquid pharmaceutical composition as claimed in  claim 5 , wherein the polysorbate is polysorbate 80. 
     
     
         7 . The liquid pharmaceutical composition according to  claim 1 , wherein the optional salt is sodium chloride. 
     
     
         8 . The liquid pharmaceutical composition according to  claim 1 , wherein the anti-IL6R antibody is selected from the group consisting of tocilizumab, sapelizumab, vobarilizumab or sarilumab. 
     
     
         9 . The liquid pharmaceutical composition according to  claim 1 , wherein the composition comprises:
 15 to 200 mg/ml of anti-IL-6R;   10 and 25 mM histidine (or histidine buffer system);   190 to 210 mM mannitol;   0.4 to 0.6 mM methionine;   0.4 to 0.9 mM polysorbate 80;   water (for injection);   75 to 125 mM sodium chloride.   
     
     
         10 . A drug delivery device comprising a liquid pharmaceutical composition as claimed in  claim 1 . 
     
     
         11 . A liquid pharmaceutical composition as claimed in  claim 1  for use in the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, Giant cell arteritis or systemic sclerosis.