Antibody Formulation

Abstract

The present invention relates to novel pharmaceutical formulations, in particular novel pharmaceutical formulations in which the active ingredient comprises human antibodies to human interleukin 1 beta (IL-1β), in particular ACZ885 antibody, pharmaceutical formulations which are stable and aggregate-free upon storage and delivery.

1 - 14 . (canceled) 
     
     
         15 . A pharmaceutical formulation, comprising
 a) an antibody to IL-1β which comprises amino acids 20 to 118 of SEQ ID NO:1 and amino acids 20 to 107 of SEQ ID NO:2, and   b) a buffer system selected from the group consisting of a citrate, histidine, sodium succinate, sodium phosphate and potassium phosphate buffer system,   
       wherein the formulation has a pH from 5.5 to 7.5. 
     
     
         16 . The formulation according to  claim 15 , wherein the pH is from 5.5 to 7. 
     
     
         17 . The formulation according to  claim 15 , wherein the pH is from 6.2 to 6.8. 
     
     
         18 . The formulation according to  claim 17 , wherein the buffer system is a histidine buffer system. 
     
     
         19 . The formulation according to  claim 18 , wherein the histidine buffer system comprises from 15 to 50 mM histidine. 
     
     
         20 . The formulation according to  claim 15 , further comprises a stabilizer. 
     
     
         21 . The formulation according to  claim 20 , wherein the stabilizer is selected from the group consisting of sucrose, trehalose, mannitol, sorbitol and arginine hydrochloride. 
     
     
         22 . The formulation according to  claim 21 , wherein the stabilizer is sucrose or mannitol in an amount from 50-300 mM. 
     
     
         23 . The formulation according to  claim 15 , further comprising one or more excipients selected from the group consisting of a bulking agent, salt, surfactant and preservative. 
     
     
         24 . The formulation according to  claim 15 , which is reconstituted from a lyophilizate. 
     
     
         25 . A lyophilizate prepared from the formulation according to  claim 15 . 
     
     
         26 . A method for preparing a formulation comprising:
 (i) lyophilizing the formulation of  claim 15 ;   (ii) reconstituting said lyophilizate with a reconstitution medium.   
     
     
         27 . A pharmaceutical formulation, comprising 10 to 150 mg/ml of an antibody to IL-1β which comprises amino acids 20 to 118 of SEQ ID NO:1 and amino acids 20 to 107 of SEQ ID NO:2, 270 mM sucrose, 30 mM histidine and 0.06% polysorbate 80, wherein the pH of the formulation is 6.5. 
     
     
         28 . A pharmaceutical formulation, comprising 10 to 150 mg/ml of an antibody to IL-1β which comprises amino acids 20 to 118 of SEQ ID NO:1 and amino acids 20 to 107 of SEQ ID NO:2, 270 mM mannitol, 20 mM histidine and 0.04% polysorbate 80, wherein the pH of the formulation is 6.5.