US2006159656A1PendingUtilityA1

Formulations for IL-11

55
Assignee: AMERICAN HOME PRODPriority: Jul 15, 1999Filed: Dec 28, 2005Published: Jul 20, 2006
Est. expiryJul 15, 2019(expired)· nominal 20-yr term from priority
Inventors:Nicholas W. WarneRebecca Lee IngramShannon Macmillan
A61K 31/7012A61K 9/19A61K 45/06A61K 38/2073
55
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Claims

Abstract

Provided by the present invention are novel compositions and methods for obtaining concentrated preparations of IL-11 and formulations of IL-11 suitable for storage and administration.

Claims

exact text as granted — not AI-modified
1 . A composition comprising IL-11, glycine and a cryoprotectant.  
   
   
       2 . The composition of  claim 1 , where said cryoprotectant is sucrose.  
   
   
       3 . The composition of  claim 1 , where said glycine is present at a concentration of about 100 to about 400 mM.  
   
   
       4 . The composition of  claim 1 , where said glycine is present at about 300 mM.  
   
   
       5 . The composition of  claim 2 , where said sucrose is present at a concentration of about 0.5 to about 2.0%.  
   
   
       6 . The composition of  claim 2 , where said sucrose is present at a concentration of about 1.0%.  
   
   
       7 . The composition of  claim 1 , further comprising a polysorbate.  
   
   
       8 . The composition of  claim 7 , wherein said polysorbate is Tween-20.  
   
   
       9 . The composition of  claim 7 , wherein said polysorbate is present at a concentration of about 0.005 to about 0.1%.  
   
   
       10 . The composition of  claim 7 , wherein said polysorbate is present at a concentration of about 0.02%.  
   
   
       11 . The composition of  claim 1 , further comprising an antioxidant.  
   
   
       12 . The composition of  claim 11 , wherein said antioxidant is L-methionine.  
   
   
       13 . The composition of  claim 12 , wherein said L-methionine is present at a concentration of about 1 to about 100 mM.  
   
   
       14 . The composition of  claim 12 , wherein said L-methionine is present at a concentration of about 10 mM.  
   
   
       15 . The composition of  claim 1 , further comprising a buffering agent.  
   
   
       16 . The composition of  claim 15 , wherein said buffering agent maintains the pH of said composition in the range of from about 6.0 to about 8.0.  
   
   
       17 . The composition of  claim 15 , wherein said buffering agent maintains the pH of said composition at about 7.0.  
   
   
       18 . The composition of  claim 15 , wherein said buffering agent is sodium phosphate.  
   
   
       19 . The composition of  claim 1 , where said IL-11 is present at a concentration of about 1 μg/ml to about 20 mg/ml.  
   
   
       20 . The composition of  claim 1 , where said IL-11 is present at a concentration of about 1 to about 5 mg/ml.  
   
   
       21 . The composition of  claim 2 , comprising about 1 to about 5 mg/ml IL-11, about 300 mM glycine, and about 1% sucrose.  
   
   
       22 . The composition of  claim 7 , comprising about 1 to about 5 mg/ml IL-11, about 300 mM glycine, about 1% sucrose, and about 0.02% polysorbate.  
   
   
       23 . The composition of  claim 12 , comprising about 1 to about 5 mg/ml IL-11, about 300 mM glycine, about 1% sucrose, about 0.02% polysorbate, and about 10 mM L-methionine.  
   
   
       24 . The composition of  claim 23 , having a pH of about 7.0.  
   
   
       25 . The composition of  claim 1 , wherein said composition is lyophilized.

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