Hfsh aqueous formulation
AssigneeLG Life Sciences Ltd.
InventorsSuk Young CHOI, Hoon Sung JEH
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Abstract
Provided is an aqueous formulation of a human follicle stimulating hormone (hFSH) which is stabilized to maintain the activity of hFSH for a prolonged period of time. The formulation of the present invention is an aqueous formulation comprising a therapeutically effective amount of hFSH stabilized in a phosphate buffer containing glycine, methionine and a non-ionic surfactant, preferably polysorbate 20, which is capable of maintaining the activity of hFSH for an extended period of time.
Claims9
An aqueous formulation of a human follicle stimulating hormone (hFSH), comprising
- a therapeutically effective amount of hFSH, and
- glycine, methionine, a non-ionic surfactant and a phosphate buffer as stabilizers;
- wherein the non-ionic surfactant is polysorbate 20 in an amount of 0.001 to 0.02% (w/v),
- the glycine is included in an amount of 0.1 to 10% (w/v),
- the methionine is included in an amount of 0.01 to 2.0% (w/v), and
- the phosphate buffer has a salt concentration of 1 mM to 50 mM and a pH of 6.5 to 7.5.
An aqueous formulation of a human follicle stimulating hormone (hFSH), consisting essentially of:
- a therapeutically effective amount of hFSH, and
- glycine, methionine, a non-ionic surfactant and a phosphate buffer as stabilizers;
- wherein the non-ionic surfactant is polysorbate 20 in an amount of 0.001 to 0.02% (w/v),
- the glycine is included in an amount of 0.1 to 10% (w/v),
- the methionine is included in an amount of 0.01 to 2.0% (w/v), and
- the phosphate buffer has a salt concentration of 1 mM to 50 mM and a pH of 6.5 to 7.5.
Dependencies are inferred from the claim text.