| US 7,585,496 B2 | ||
| Stable pharmaceutical composition granulocyte-colony stimulating factor | ||
| Barbara Podobnik, Ljubljana (Slovenia); Vladka Gaberc Porekar, Ljubljana (Slovenia); and Viktor Menart, Logatec (Slovenia) | ||
| Assigned to Lek Pharmaceuticals d.d., Ljubljana (Slovenia) | ||
| Appl. No. 10/577,285 PCT Filed Nov. 04, 2003, PCT No. PCT/IB03/05575 § 371(c)(1), (2), (4) Date Oct. 10, 2006, PCT Pub. No. WO2005/042024, PCT Pub. Date May 12, 2005. |
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| Prior Publication US 2007/0081971 A1, Apr. 12, 2007 | ||
| Int. Cl. A61K 45/00 (2006.01); A61K 38/19 (2006.01); C07K 14/00 (2006.01); A61K 47/02 (2006.01); A61K 47/12 (2006.01) | ||
| U.S. Cl. 424—85.1 [530/351; 514/12] | 19 Claims |
| 1. A stable pharmaceutical composition of granulocyte-colony stimulating factor (G-CSF) comprising:
a therapeutically effective amount of a non-glycosylated G-CSF in a concentration ranging from about 0.3 mg/ml to about 0.96
mg/ml, and
an acid, wherein the composition is free of any surfactant, the composition is an aqueous liquid, and the composition has
a pH value ranging from about 4.2 to about 4.8
wherein the amount of G-CSF higher aggregates in the composition after storage for 1 month at 40 degrees C. is no more than
about 0.65% of the amount of G-CSF in the composition.
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