Aqueous formulation of erythropoiesis stimulating protein stabilised by antioxidants for parenteral administration
AssigneeAmgen Inc.
InventorsChristopher James Sloey, Jason Ko, Tiansheng Li
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Abstract
The present invention relates to stable aqueous protein formulations. In particular, disclosed herein are therapeutic protein formulations suitable for parenteral administration having one or more antioxidants.
Claims8
An aqueous formulation suitable for parenteral administration comprising an erythropoiesis stimulating protein, wherein the erythropoiesis stimulating protein is a protein that is 90% or more identical in amino acid sequence to human erythropoietin (SEQ ID NO:
- 1) or darbepoetin (SEQ ID NO:
- 2), and a stabilizing concentration of an antioxidant, wherein the antioxidant is syringic acid and wherein the antioxidant is present in the aqueous formulation at a concentration of about 0.1 mM to about 20 mM.
An aqueous formulation suitable for parenteral administration comprising an erythropoiesis stimulating protein, wherein the erythropoiesis stimulating protein is a protein that is 90% or more identical in amino acid sequence to human erythropoietin (SEQ ID NO:
- 1) or darbepoetin (SEQ ID NO:
- 2), and a stabilizing concentration of an antioxidant, wherein the antioxidant is selected from the group consisting of coumaric acid, ferulic acid, and sinapic acid, and wherein the antioxidant is present in the aqueous formulation at a concentration of about 0.1 mM to about 20 mM.
An aqueous formulation suitable for parenteral administration comprising an erythropoiesis stimulating protein, wherein the erythropoiesis stimulating protein is a protein that is 90% or more identical in amino acid sequence to human erythropoietin (SEQ ID NO:
- 1) or darbepoetin (SEQ ID NO:
- 2), and a stabilizing concentration of an antioxidant, wherein the antioxidant is selected from the group consisting of furaneol and sulisobenzone, and wherein,
- when the antioxidant is furaneol, the antioxidant is present in the aqueous formulation at a concentration of about 0.1 mM to about 300 mM and
- when the antioxidant comprises sulisobenzone, the antioxidant is present in the aqueous formulation at a concentration of about 0.1 mM to about 300 mM.
Dependencies are inferred from the claim text.