US2015150984A1PendingUtilityA1

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

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Assignee: AMGEN INCPriority: Jun 20, 2002Filed: Feb 3, 2015Published: Jun 4, 2015
Est. expiryJun 20, 2022(expired)· nominal 20-yr term from priority
Inventors:Bruce KerwinByeong Seon ChangLei Shi
A61P 7/06A61P 9/10A61P 39/00A61P 9/00A61P 3/10A61P 9/04A61P 43/00A61P 37/00A61P 41/00A61P 25/00A61P 25/02A61P 25/04A61P 25/08A61P 29/00A61P 31/04A61P 27/02A61P 35/02A61P 35/00A61P 11/00A61P 1/18A61P 19/00A61P 17/06A61P 17/02A61P 1/04A61P 17/00A61P 19/02A61P 21/00A61K 47/02A61K 47/26A61K 47/60A61K 47/183A61K 47/10A61K 38/1816A61K 38/1793A61K 9/19A61K 31/198A61K 9/0019A61K 47/12A61K 47/48215Y02A50/30
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Claims

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.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . A pharmaceutical formulation comprising
 (a) a tonicity modifier selected from the group consisting of mannitol, sorbitol, and sucrose,   (b) a polysorbate, and   (c) a tumor necrosis factor (TNF) inhibitor at a concentration of at least 45 mg/mL,   wherein the TNF inhibitor comprises a polypeptide, and   wherein the viscosity of the pharmaceutical formulation including the tonicity modifier is less than 400 cP.   
     
     
         2 . The pharmaceutical formulation of  claim 1 , comprising mannitol. 
     
     
         3 . The pharmaceutical formulation of  claim 1 , comprising sucrose. 
     
     
         4 . The pharmaceutical formulation of  claim 1 , wherein the polysorbate is polysorbate 80. 
     
     
         5 . The pharmaceutical formulation of  claim 1 , comprising mannitol and polysorbate 80. 
     
     
         6 . The pharmaceutical formulation of  claim 1 , comprising sucrose and polysorbate 80. 
     
     
         7 . The pharmaceutical formulation of  claim 1 , further comprising acetate. 
     
     
         8 . The pharmaceutical formulation of  claim 7 , comprising 10 mM sodium acetate. 
     
     
         9 . The pharmaceutical formulation of  claim 1 , further comprising sodium citrate. 
     
     
         10 . The pharmaceutical formulation of  claim 1 , further comprising citric acid. 
     
     
         11 . The pharmaceutical formulation of  claim 1 , wherein the pH of the pharmaceutical formulation is between pH 5 and 6. 
     
     
         12 . The pharmaceutical formulation of  claim 1 , wherein the concentration of the TNF inhibitor is less than or equal to 55 mg/mL. 
     
     
         13 . The pharmaceutical formulation of  claim 1 , further comprising sodium chloride. 
     
     
         14 . The pharmaceutical formulation of  claim 1 , further comprising sodium phosphate. 
     
     
         15 . The pharmaceutical formulation of  claim 1 , wherein the TNF inhibitor comprises sTNF-RI, truncated sTNF-RI, sTNF-RII, or truncated sTNF-RII. 
     
     
         16 . The pharmaceutical formulation of  claim 15 , wherein the TNF inhibitor comprises PEGsTNF-RI. 
     
     
         17 . The pharmaceutical formulation of  claim 1 , wherein the TNF inhibitor comprises 40 kDa TNF inhibitor Δ51 or 40 kDa TNF inhibitor Δ53. 
     
     
         18 . A pre-filled syringe containing the pharmaceutical formulation of  claim 1 .

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