| 摘要 |
The invention relates to a stable freeze-dried formulation comprising FGF-18, a phosphate buffer which keeps the pH comprised between 7.0 and 7.5, a poloxamer 188 and sucrose, and to a method of producing said stable freeze-dried formulation, comprising the steps of: a. forming a mixture of FGF-18 together with the phosphate buffer which keeps the pH comprised between 7.0 and 7.5, the poloxamer 188 and sucrose, and b. subjecting the mixture to lyophilization. The invention also relates to an article of manufacture comprising a first container comprising the stable freeze-dried formulation and a second container comprising a solvent for reconstitution. The freeze-dried formulations according to the invention are stable upon storage for an appropriate period of time. |
