Method of treatment using stable liquid formulation of G-CSF
Provided are pharmaceutical liquid formulations of G-CSF, which are stable over a long time period and substantially free of excipients, as well as ready-to-use syringes containing such formulations and corresponding kits.
1. A method for the treatment of cancer, severe chronic neutropenia (SCN), HIV infection, a damage of the central nervous system, adverse side effects owing to cytotoxic chemotherapy, or for the accompanying therapy of diseases, wherein a mobilization of peripheral blood precursor cells is required, the method comprising administering a therapeutically effective amount of a medicament to a patient in need thereof, wherein the medicament comprises an aqueous liquid formulation of G-CSF, the aqueous liquid formulation of G-CSF comprising G-CSF, sorbitol at a concentration of 5% w/v, polysorbate at a concentration of 0.05 to 0.06 mg/ml, and acetate at a concentration of 10 mM as a buffer substance at a pH value of 4.15 to 4.3.
2. The method of claim 1 , wherein the medicament is administered by subcutaneous or intravenous administration.
3. The method of claim 2 , wherein the administration of G-CSF is provided at a dosage of 5 to 30 μg/kg body weight.
4. The method of claim 1 , wherein the G-CSF is non-glycosylated.
5. The method of claim 1 , wherein the G-CSF is present at a concentration of 0.6 mg/ml.
6. The method of claim 1 , wherein the medicament is substantially free of amino acids and/or additional protein.
7. The method of claim 1 , wherein the medicament is an injection or infusion solution.
8. The method of claim 1 , wherein the aqueous liquid formulation of G-CSF consists of human, non-glycosylated methionyl G-CSF at a concentration of 0.6 mg/ml, sorbitol at a concentration of 5% (w/v), polysorbate 80 at a concentration of 0.05 to 0.06 mg/ml, and acetate at a concentration of 10 mM as a buffer substance.
9. The method of claim 1 , wherein the buffer substance is provided in the form of its free acid and the pH value of the solution is adjusted by the addition of a base.
10. The method of claim 1 , wherein the G-CSF is non-glycosylated and present at a concentration of 0.6 mg/ml and the pH value is 4.2 and wherein the medicament is substantially free of amino acids and/or additional proteins.
11. The method of claim 1 , wherein the medicament further comprises an amino acid, glycerol, a carbohydrate, and/or a preservative.
12. The method of claim 1 , wherein the medicament contains less than 1% oxidized species after storage for 4 weeks at 40° C. or 5° C.