Pharmaceutical formulations of tnf-alpha antibodies

Abstract

The present invention provides certain improved formulations of proteins. Specifically, the present invention provides use of certain excipients that are useful for stabilization of antibody preparations. Additionally, the novel formulation of the present invention prevents the formation of aggregates or fragments or modification of protein in solution.

1 .- 41 . (canceled) 
     
     
         42 . A liquid pharmaceutical formulation comprising
 (a) adalimumab or an antigen binding portion thereof at a concentration of 50 mg/mL-160 mg/mL,   (b) a stabilizer comprising an amino acid selected from histidine, methionine, and a combination thereof,   (c) 0.01% to 1% of a surfactant selected from polysorbate 80, polysorbate 20 and a combination thereof; and   (d) 1-100 mM of a buffer selected from histidine buffer, citrate buffer, and a combination thereof,   wherein the pH of the formulation is between pH 4.0 and 6.0.   
     
     
         43 . The formulation of  claim 42 , wherein the stabilizer comprises from 1% to 10% of a sugar selected from sorbitol or sucrose. 
     
     
         44 . The formulation of  claim 42 , wherein the stabilizer consists essentially of
 (i) an amino acid selected from histidine, methionine, and a combination thereof or   (ii) an amino acid selected from histidine, methionine, and a combination thereof and from 1% to 10% of a sugar selected from sorbitol or sucrose.   
     
     
         45 . The formulation of  claim 42 , wherein the concentration of the adalimumab or an antigen binding portion thereof is 50 mg/mL. 
     
     
         46 . The formulation of  claim 42 , wherein the pH of the formulation is pH 5.2. 
     
     
         47 . The formulation of  claim 42 , wherein the buffer is present at a concentration of 5 mM to 50 mM. 
     
     
         48 . The formulation of  claim 46 , wherein the formulation comprises a histidine buffer. 
     
     
         49 . The formulation of  claim 42 , wherein the amino acid is present at a concentration of 1% to 10%. 
     
     
         50 . The formulation of  claim 42 , wherein the amino acid is histidine. 
     
     
         51 . The formulation of  claim 42 , wherein the amino acid is methionine. 
     
     
         52 . The formulation of  claim 42 , further comprising a tonicity agent. 
     
     
         53 . A lyophilized formulation comprising the composition of  claim 42 .