Reduced-viscosity concentrated protein formulations

Abstract

The present application concerns concentrated protein formulations with reduced viscosity, which arc particularly suitable for subcutaneous administration. The application further concerns a method for reducing the viscosity of concentrated protein formulations.

1 .- 55 . (canceled) 
     
     
         56 . A stable liquid formulation comprising a monoclonal antibody in an amount of at least about 80 mg/ml and a salt and/or buffer in an amount of at least 50 mM, wherein the salt and/or buffer is derived from arginine or histidine. 
     
     
         57 . The formulation of  claim 56 , comprising said salt and/or buffer in an amount of about 50-200 mM. 
     
     
         58 . The formulation of  claim 57 , comprising said salt and/or buffer in an amount of about 100-200 mM. 
     
     
         59 . The formulation of  claim 56 , wherein said salt and/or buffer is in an amount of about 50 mM. 
     
     
         60 . The formulation of  claim 56 , wherein said salt and/or buffer comprises arginine. 
     
     
         61 . The formulation of  claim 56 , wherein said salt and/or buffer is arginine hydrochloride. 
     
     
         62 . The formulation of  claim 56 , wherein said salt and/or buffer comprises histidine. 
     
     
         63 . The formulation of  claim 56 , further comprising a lyoprotectant. 
     
     
         64 . The formulation of  claim 63 , wherein said lyoprotectant is a sugar. 
     
     
         65 . The formulation of  claim 64 , wherein said sugar is sucrose or trehalose. 
     
     
         66 . The formulation of  claim 65 , comprising said sugar in an amount of about 60-300 mM. 
     
     
         67 . The formulation of  claim 56 , further comprising a surfactant. 
     
     
         68 . The formulation of  claim 67 , wherein the surfactant is a polysorbate. 
     
     
         69 . The formulation of  claim 68 , wherein the polysorbate is polysorbate 20. 
     
     
         70 . The formulation of  claim 56  which is a reconstituted formulation. 
     
     
         71 . The formulation of  claim 70 , wherein the antibody concentration in the reconstituted formulation is about 2-40 times greater than the antibody concentration in the mixture before lyophilization. 
     
     
         72 . The formulation of  claim 56 , wherein the antibody is in an amount of about 80 mg/ml to about 300 mg/ml. 
     
     
         73 . The formulation of  claim 56 , wherein the antibody is in an amount of about 90 mg/ml to about 150 mg/ml. 
     
     
         74 . The formulation of  claim 56  which is a liquid pharmaceutical formulation. 
     
     
         75 . The formulation of  claim 74  which is for subcutaneous administration. 
     
     
         76 . An article of manufacture comprising a container containing the formulation of claim /// 56 . 
     
     
         77 . The article of manufacture of  claim 76  further comprising directions for administration of said formulation.