发明名称 |
PHARMACEUTICAL FORMULATION AND PROCESS |
摘要 |
A process for lyophilization or freeze-drying of a pharmaceutical product is provided and a liquid formulation suitable for lyophilization. In particular, a process for lyophilization or freeze-drying a liquid formulation that includes a protein active agent, a bulking agent and a saccharide stablilizing agent is provided. The saccharide to bulking agent ratio and the protein concentration of the formulation are important factors that affect crystallization of the bulking agent during lyophilization and storage as are some processing conditions. In one embodiment, the saccharide is a disaccharide, such as sucrose and the crystalline bulking agent is mannitol. The protein can be an antibody or a non-antibody protein.
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申请公布号 |
WO2006014965(A9) |
申请公布日期 |
2006.03.30 |
申请号 |
WO2005US26506 |
申请日期 |
2005.07.27 |
申请人 |
HUMAN GENOME SCIENCES, INC.;KRISHNAMURTHY, RAJESH;SURYANARAYANAN, RAJ |
发明人 |
KRISHNAMURTHY, RAJESH;SURYANARAYANAN, RAJ |
分类号 |
A61K39/00 |
主分类号 |
A61K39/00 |
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