Liquid pharmaceutical composition of adalimumab

Abstract

The present invention relates to a liquid pharmaceutical composition comprising an anti-TNFα antibody, buffer, stabilizer, and surfactant.

1 . An aqueous pharmaceutical formulation comprising an anti-TNFα antibody, buffer which is selected from the group consisting of acetate, arginine, glycine or a combination thereof, Polysorbate 80 as surfactant and Sucrose as stabilizer. 
     
     
         2 . The aqueous pharmaceutical formulation of  claim 1 , wherein an anti-TNFα antibody is Adalimumab. 
     
     
         3 . The aqueous pharmaceutical formulation of  claim 1 , wherein the concentration of Adalimumab is between 1 mg/mL to 100 mg/mL. 
     
     
         4 . The aqueous pharmaceutical formulation of  claim 1 , wherein the pH of the formulation is between pH 4.5 to 6.5. 
     
     
         5 . The aqueous pharmaceutical formulation of  claim 1 , wherein the buffer is in the concentration of 1 mM to 100 mM. 
     
     
         6 . The aqueous pharmaceutical formulation of  claim 1 , wherein the Polysorbate 80 is present in the concentration of 0.001% to 1%. 
     
     
         7 . The aqueous pharmaceutical formulation of  claim 1 , wherein the Sucrose is present in the concentration from 1% to 10%. 
     
     
         8 . An aqueous pharmaceutical formulation Adalimumab comprising acetate as buffer, sucrose and Polysorbate 80 at pH 5.2 wherein Adalimumab is present at a concentration of 1 mg/mL to 100 mg/mL. 
     
     
         9 . An aqueous pharmaceutical formulation as claimed in  claim 8  comprising:
 a) 50 mg/mL Adalimumab, 
 b) 1.0 mM acetate buffer, 
 c) 9.5% sucrose, and 
 d) 0.1% Polysorbate 80 at pH 5.2. 
 
     
     
         10 . An aqueous pharmaceutical formulation Adalimumab comprising arginine as buffer, sucrose and Polysorbate 80 at pH 5.2 wherein Adalimumab is present at a concentration of 1 mg/mL to 100 mg/mL. 
     
     
         11 . The aqueous pharmaceutical formulation as claimed in  claim 10  comprising,
 e) 50 mg/mL Adalimumab, 
 f) 15 mM arginine buffer, 
 g) 9.5% sucrose, and 
 h) 0.1% Polysorbate 80 at pH 5.2. 
 
     
     
         12 . An aqueous pharmaceutical formulation of Adalimumab comprising glycine as buffer, sucrose and Polysorbate 80 at pH 5.2 wherein Adalimumab is present at a concentration of 1 mg/mL to 100 mg/mL. 
     
     
         13 . The aqueous pharmaceutical formulation as claimed in  claim 12  comprising:
 a) 50 mg/mL Adalimumab 
 b) 15 mM glycine buffer 
 c) 9.5% sucrose 
 d) 0.1% Polysorbate 80 at pH 5.2.