US2004248797A1PendingUtilityA1

Pharmaceutical compositions of erythropoietin

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Assignee: ORTHO MCNEIL PHARM INCPriority: Apr 9, 1999Filed: Feb 10, 2004Published: Dec 9, 2004
Est. expiryApr 9, 2019(expired)· nominal 20-yr term from priority
Inventors:Wing Kit CheungJaya NatarajanMarilyn SandersEls VercammenSelima BegumBasant Sharma
A61P 7/08A61P 35/00A61P 5/00A61P 7/06A61K 9/0019A61K 47/183A61K 47/10A61K 47/26A61K 38/1816A61K 47/12A61K 47/02A61K 47/42A61K 38/22
46
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Claims

Abstract

The present invention provides aqueous pharmaceutical formulations of erytropoietin that are free of human serum blood products, stabilized with a quantity of an amino acid and a sorbitan mono-9-octadecenoate poly(oxy-1,2-ethanediyl) derivative. The present invention also provides aqueous stable, preserved pharmaceutical formulations of erythropoietin that contain an antimicrobial quantity of cresol and a quantity of an amino acid.

Claims

exact text as granted — not AI-modified
What is claimed is:  
     
         1 . A pharmaceutical formulation of erythropoietin comprising: 
 (a) a pH buffering agent;    (b) a stabilizing amount of a sorbitan mono-9-octadecenoate poly(oxy-1,2-ethanediyl) derivative;    (c) a stabilizing amount of an amino acid;    (d) a pharmaceutical quantity of erythropoietin; and    wherein the formulation does not contain urea or a human blood product.    
     
     
         2 . The formulation of  claim 1  wherein the formulation is aqueous.  
     
     
         3 . The formulation of  claim 1  wherein the pH buffering agent is in a range of about 10 mM to about 30 mM.  
     
     
         4 . The formulation of  claim 1  wherein the pH buffering agent provides a pH range from about 5 to about 8.  
     
     
         5 . The formulation of  claim 3  wherein the pH buffering agent provides a pH range from about 6 to about 7.5.  
     
     
         6 . The formulation of  claim 5  wherein the pH buffering agent provides a pH of about 6.9.  
     
     
         7 . The formulation of  claim 1  wherein the pH buffering agent is selected from a group consisting of sodium phosphate monobasic/sodium phosphate dibasic, sodium citrate/citric acid, and sodium acetate/acetic acid.  
     
     
         8 . The formulation of  claim 7  wherein the pH buffering agent is in a range of about 10 mM to about 30 mM.  
     
     
         9 . The formulation of  claim 8  wherein the pH buffering agent provides a pH range from about 5 to about 8.  
     
     
         10 . The formulation of  claim 9  wherein the pH buffering agent provides a pH range from about 6 to about 7.5.  
     
     
         11 . The formulation of  claim 10  wherein the pH buffering agent provides a pH of about 6.9.  
     
     
         12 . The formulation of  claim 1  wherein the sorbitan mono-9-octadecenoate poly(oxy-1,2-ethanediyl) derivative is selected from the group consisting of polysorbate 80 and polysorbate 20.  
     
     
         13 . The formulation of  claim 1  wherein the amino acid is glycine.  
     
     
         14 . The formulation of  claim 1  further comprising a tonicity agent, wherein the tonicity agent is selected from a group consisting of sodium chloride, mannitol, glycine, glucose and sorbitol.  
     
     
         15 . The formulation of  claim 1  wherein the pharmaceutical quantity of erythropoietin is formulated to provide a quantity per dose in the range of about 1000 IU to about 100,000 IU erythropoietin.  
     
     
         16 . The formulation of  claim 15  wherein the pharmaceutical quantity of erythropoietin is formulated to provide a quantity per dose selected from the group consisting of about 2,000 IU, about 3,000 IU, about 4,000 IU, about 10,000 IU, about 20,000 IU, about 25,000 IU or about 40,000 IU.  
     
     
         17 . The formulation of  claim 16  wherein the sorbitan mono-9-octadecenoate poly(oxy-1,2-ethanediyl) derivative is polysorbate 80 and the amino acid is glycine.  
     
     
         18 . The formulation of  claim 17  wherein polysorbate is in the range of about 0.01 to about 1.0 g/L and glycine is in the range of about 1 g/L to about 50 g/L.  
     
     
         19 . The formulation of  claim 18  further comprising a tonicity agent, wherein the tonicity agent is selected from the group consisting of sodium chloride, mannitol, glycine, glucose and sorbitol.  
     
     
         20 . The formulation of  claim 19  wherein the pH buffering agent is selected from a group consisting of sodium phosphate monobasic/sodium phosphate dibasic, sodium citrate/citric acid, and sodium acetate/acetic acid.  
     
     
         21 . The formulation of  claim 20  wherein the pH buffering agent provides a pH in the range of about pH 5 to about pH 8.  
     
     
         22 . A pharmaceutical formulation of erythropoietin comprising: 
 (a) a pH buffering agent;    (b) a stabilizing amount of sorbitan mono-9-octadecenoate poly(oxy-1,2-ethanediyl) derivative;    (c) a stabilizing amount of an amino acid;    (d) a pharmaceutical quantity of erythropoietin;    (e) a tonicity agent; and    wherein the formulation does not contain urea or a human blood product.    
     
     
         23 . The formulation of  claim 22  wherein the formulation is aqueous.  
     
     
         24 . The formulation of  claim 22  wherein the pH buffering agent is in a range of about 10 mM to about 30 mM.  
     
     
         25 . The formulation of  claim 22  wherein the pH buffering agent provides a pH range from about 5 to about 8.  
     
     
         26 . The formulation of  claim 24  wherein the pH buffering agent provides a pH range from about 6 to about 7.5.  
     
     
         27 . The formulation of  claim 26  wherein the pH buffering agent provides a pH of about 6.9.  
     
     
         28 . The formulation of  claim 22  wherein the pH buffering agent is selected from a group consisting of sodium phosphate monobasic/sodium phosphate dibasic, sodium citrate/citric acid, and sodium acetate/acetic acid.  
     
     
         29 . The formulation of  claim 28  wherein the pH buffering agent is in a range of about 10 mM to about 30 mM.  
     
     
         30 . The formulation of  claim 29  wherein the pH buffering agent provides a pH range from about 5 to about 8.  
     
     
         31 . The formulation of  claim 30  wherein the pH buffering agent provides a pH range from about 6 to about 7.5.  
     
     
         32 . The formulation of  claim 31  wherein the pH buffering agent provides a pH of about 6.9.  
     
     
         33 . The formulation of  claim 22  wherein the sorbitan mono-9-octadecenoate poly(oxy-1,2-ethanediyl) derivative is selected from the group consisting of polysorbate 80 and polysorbate 20.  
     
     
         34 . The formulation of  claim 22  wherein the amino acid is glycine.  
     
     
         35 . The formulation of  claim 22  wherein the tonicity agent is selected from a group consisting of sodium chloride, mannitol, glycine, glucose and sorbitol.  
     
     
         36 . The formulation of  claim 22  wherein the pharmaceutical quantity of erythropoietin is formulated to provide a quantity per dose in the range of about 1000 IU to about 100,000 IU erythropoietin.  
     
     
         37 . The formulation of  claim 36  wherein the pharmaceutical quantity of erythropoietin is formulated to provide a quantity per dose selected from the group consisting of about 2,000 IU, about 3,000 IU, about 4,000 U, about 10,000 IU, about 20,000 IU, about 25,000 IU or about 40,000 IU.  
     
     
         38 . The formulation of  claim 31  wherein the sorbitan mono-9-octadecenoate poly(oxy- 1,2-ethanediyl) derivative is polysorbate 80 and the amino acid is glycine.  
     
     
         39 . The formulation of  claim 38  wherein polysorbate is in the range of about 0.01 to about 1.0 g/L and glycine is in the range of about 1 g/L to about 50 g/L.  
     
     
         40 . The formulation of  claim 39  further comprising a tonicity agent, wherein the tonicity agent is selected from the group consisting of sodium chloride, mannitol, glycine, glucose and sorbitol.  
     
     
         41 . The formulation of  claim 40  wherein the pH buffering agent is selected from a group consisting of sodium phosphate monobasic/sodium phosphate dibasic, sodium citrate/citric acid, and sodium acetate/acetic acid.  
     
     
         42 . The formulation of  claim 41  wherein the pH buffering agent provides a pH in the range of about pH 5 to about pH 8.

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