Patent ID: 7446090

Claim:
A method for providing a stable, liquid, multi-use human FSH formulation comprising: preparing an aqueous pharmaceutical formulation comprising human FSH and a preservative selected from the group consisting of benzyl alcohol, m-cresol and mixtures thereof, the human FSH consisting of an α-subunit having SEQ ID NO:5 and a β-subunit having SEQ ID NO:6 held together by noncovalent interactions, the human FSH being present as the biologically-active, heterodimeric protein form of human FSH at a concentration of about 5.0 μg/mL to about 200 μg/mL, the preservative being present in an amount effective to yield anti-microbial effect for the formulation; and placing the formulation into a vial, the formulation having a stability such that it contains a pharmaceutically-effective mount of FSH after being held in the vial for a period of twenty four hours or greater.