Freeze-dried formulations of FGF-18

摘要

The invention relates to the field of pharmaceutical formulations. More particularly it is directed to freeze-dried formulations of Fibroblast Growth Factor 18 (FGF-18) compound and to methods of producing such formulations. The freeze-dried formulations according to the invention are stable upon storage for an appropriate period of time. They can be used, after reconstitution, for the treatment of cartilage disorders such as osteoarthritis or cartilage injury.

主权项

1. A freeze-dried formulation comprising fibroblast growth factor 18 (FGF-18), a buffer, a poloxamer surfactant and a sugar as stabilizing agent, wherein the buffer is a phosphate buffer at a concentration at or about 5 to 100 mM and maintains the pH between 7.0 and 7.5, the poloxamer surfactant is poloxamer 188 at a concentration at or about 0.1 to 0.4 mg/vial and the sugar is sucrose at a concentration at or about 10 to 60 mg/vial.