Hydroxyethyl starch-containing polypeptide compositions

Abstract

The invention provides compositions containing hydroxyethyl starch and polypeptides, including therapeutic polypeptides such as interleukin-11, that provide for enhanced stability of the polypeptide following storage at room temperature or elevated temperatures.

1 .- 25 . (canceled) 
     
     
         26 . A method of treating or preventing inflammation in a subject, the method comprising administering to said subject a composition comprising a polypeptide, a disaccharide, and hydroxyethyl starch, wherein said polypeptide does not include an N-linked glycosylation site and is stable for at least 9 months when said composition is stored at 60° C. 
     
     
         27 . The method of  claim 26 , wherein said subject is a human. 
     
     
         28 . The method of  claim 26 , wherein said inflammation is associated with inflammatory bowel disease. 
     
     
         29 . The method of  claim 28 , wherein said inflammatory bowel disease is Crohn's disease. 
     
     
         30 . The method of  claim 26 , wherein said disaccharide is sucrose present at a concentration of 2.5% (wt/vol) to 5.0% (wt/vol), and said hydroxyethyl starch is present at a concentration of 2.5% (wt/vol). 
     
     
         31 . The method of  claim 26 , wherein said disaccharide is trehalose present at a concentration of 2.5% (wt/vol) to 5.0% (wt/vol), and said hydroxyethyl starch is present at a concentration of 2.5% (wt/vol). 
     
     
         32 . A method of enhancing an immune response in a subject, the method comprising administering to said subject a composition comprising a polypeptide, a disaccharide, and hydroxyethyl starch, wherein said polypeptide does not include an N-linked glycosylation site and is stable for at least 9 months when said composition is stored at 60° C. 
     
     
         33 . The method of  claim 32 , wherein said subject is a human. 
     
     
         34 . The method of  claim 33 , wherein said composition is administered in a route selected from the group consisting of intramuscular, intravenous, intraarterial, intradermal, intraperitoneal and subcutaneous delivery. 
     
     
         35 . The method of  claim 32 , wherein said disaccharide is sucrose present at a concentration of 2.5% (wt/vol) to 5.0% (wt/vol), and said hydroxyethyl starch is present at a concentration of 2.5% (wt/vol). 
     
     
         36 . The method of  claim 32 , wherein said disaccharide is trehalose present at a concentration of 2.5% (wt/vol) to 5.0% (wt/vol), and said hydroxyethyl starch is present at a concentration of 2.5% (wt/vol). 
     
     
         37 . A method of increasing platelet production in a subject, the method comprising administering a subject in need thereof a composition comprising a polypeptide, a disaccharide, and hydroxyethyl starch, wherein said polypeptide does not include an N-linked glycosylation site and is stable for at least 9 months when said composition is stored at 60° C. 
     
     
         38 . The method of  claim 37 , wherein said subject is a human. 
     
     
         39 . The method of  claim 38 , wherein said subject has or is at risk for developing a tumor. 
     
     
         40 . The method of  claim 39 , wherein said tumor is a solid tumor or a lymphoma. 
     
     
         41 . The method of  claim 39 , wherein said subject is undergoing treatment for said tumor.