发明名称 |
STABLE LYOPHILIZED PHARMACEUTICAL FORMULATION OF IGG ANTIBODIES |
摘要 |
This invention is directed to a stable lyophilized pharmaceutical formulation prepared by lyophilizing an aqueous formulation comprising a high concentration, e.g. 50 mg/ml or more,of an IgG antibody in about 5-25 mM histidine buffer having pH from about 5.5 to about 6.5,about 0.005 % - 0.03 % polysorbate, sucrose, and optionally serine, and/or mannitol. This lyophilized formulation is stable at room temperature for at least 6 months, and preferably 1year. This lyophilized formulation has a short reconstitution time of less than 2 minutes, andis suitable for parenteral administration such as intravenous, intramuscular, intraperitoneal,or subcutaneous injection. This invention is exemplified by the anti-IL2 receptor antibody. |
申请公布号 |
WO03009817(A2) |
申请公布日期 |
2003.02.06 |
申请号 |
WO2002US24078 |
申请日期 |
2002.07.25 |
申请人 |
PROTEIN DESIGN LABS, INC.;KAISHEVA, ELIZABET, A.;FLORES-NATE, ALENI;GUPTA, SUPRIYA |
发明人 |
KAISHEVA, ELIZABET, A.;FLORES-NATE, ALENI;GUPTA, SUPRIYA |
分类号 |
A61K9/19;A61K39/395;A61K47/14;A61K47/18;A61K47/26;A61K47/36;A61P43/00;C07K16/28;C12P21/08 |
主分类号 |
A61K9/19 |
代理机构 |
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代理人 |
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主权项 |
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地址 |
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