Liquid pharmaceutical composition

Abstract

The present invention relates to a novel protein formulation. In particular, the invention relates to a liquid pharmaceutical composition of tocilizumab, 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) tocilizumab antibody;   (b) a histidine buffer;   (c) a stabilizer selected from lactic acid or salts thereof;   (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 7.0. 
     
     
         2 . The liquid pharmaceutical according to  claim 1 , wherein the composition has a pH between 5.8 and 6.2. 
     
     
         3 . The liquid pharmaceutical composition according to  claim 1 , wherein the stabilizer is lactic acid or sodium lactate. 
     
     
         4 . The liquid pharmaceutical composition according to  claim 1 , wherein the free amino acid is arginine. 
     
     
         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  claim 1 , wherein the composition comprises:
 15 to 200 mg/ml of tocilizumab antibody;   10 and 25 mM histidine;   5 to 15 mM sodium lactate or lactic acid;   50 to 150 mM arginine   0.1 to 0.2 mM polysorbate 80   water for injection; and   optionally 5 to 50 mM sodium chloride.   
     
     
         9 . The liquid pharmaceutical composition according to  claim 1 , wherein the composition comprises:
 15 to 200 mg/ml of tocilizumab antibody;   10 and 25 mM histidine;   5 to 15 mM sodium lactate or lactic acid;   50 to 150 mM arginine   0.1 to 0.2 mM polysorbate 80   water for injection; and   5 to 50 mM sodium chloride.   
     
     
         10 . A drug delivery device comprising a liquid pharmaceutical composition as claimed in  claim 1 . 
     
     
         11 . A method of treatment, comprising:
 administering a liquid pharmaceutical composition as claimed in  claim 1  to a patient having a disease selected from rheumatoid arthritis, juvenile idiopathic arthritis, Giant cell arteritis or systemic sclerosis thereby treating the patient for the disease.