Compositions of pegylated soluble tumor necrosis factor receptors and methods of preparing

Abstract

The present invention provides for improved compositions comprising a PEGsTNF-R1 which, in addition to having useful higher concentrations, demonstrate decreased viscosity (<400 cP) and improved stability.

What is claimed is: 
     
         1 . A pharmaceutical formulation comprising:
 (a) a tonicity modifier, wherein the tonicity modifier is sorbitol and/or glycine; and   (b) a pegylated erythropoietin at a concentration of at least 45 mg/mL;   wherein the viscosity of the pharmaceutical formulation is less than 400 cP.   
     
     
         2 . The formulation of  claim 1 , wherein the tonicity modifier comprises 1% to 5.48% (w/v) sorbitol, preferably 1.5% to 5.48% (w/v), 2% to 5.48% (w/v), or 2.56% to 5.48% (w/v). 
     
     
         3 . The formulation of  claim 1 , wherein the tonicity modifier comprises 5.48% (w/v) sorbitol. 
     
     
         4 . The formulation of  claim 1 , wherein the tonicity modifier comprises 1% to 2.19% (w/v) glycine, preferably 1.25% to 2.19% (w/v) or 1.5% to 2.19% (w/v). 
     
     
         5 . The formulation of  claim 1 , wherein the tonicity modifier comprises 2.19% (w/v) glycine. 
     
     
         6 . The formulation of  claim 1 , wherein the tonicity modifier comprises 1.1% (w/v) glycine and 2.74% (w/v) sorbitol. 
     
     
         7 . The formulation of  claim 1 , further comprising a buffer. 
     
     
         8 . The formulation of  claim 7 , wherein the buffer is acetate. 
     
     
         9 . The formulation of  claim 1 , wherein the formulation has a pH in the range of 4.0 to 5.0. 
     
     
         10 . The formulation of  claim 1 , wherein the pegylated erythropoietin is at a concentration of up to 55 mg/mL. 
     
     
         11 . A pharmaceutical formulation comprising:
 (a) a tonicity modifier, wherein the tonicity modifier is 1% to 5.48% (w/v) sorbitol and/or 1% to 2.19% (w/v) glycine;   (b) an acetate buffer; and   (c) a pegylated erythropoietin at a concentration of at least 45 mg/mL up to 55 mg/mL;   wherein the formulation has a pH of 4.0 to 5.0.   
     
     
         12 . The formulation of  claim 11 , wherein the pH is 4.9.