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    • 1. 发明申请
    • Immunoconjugate formulations
    • 免疫缀合物制剂
    • US20070031402A1
    • 2007-02-08
    • US11498139
    • 2006-08-03
    • Wei ZhangMichael FlemingGodfrey AmphlettHung-wei ChihElizabeth Bartlett
    • Wei ZhangMichael FlemingGodfrey AmphlettHung-wei ChihElizabeth Bartlett
    • A61K39/395
    • A61K47/48561A61K9/0019A61K47/10A61K47/26A61K47/40A61K47/6803A61K47/6849A61K47/6863
    • The present invention provides an immunoconjugate formulation that is substantially free of particles, the immunoconjugate formulation comprising: an immunoconjugate and one or more excipients selected from the group consisting of: sucrose, polysorbate 20, polysorbate 80, cyclodextrin, dextrose, glycerol, polyethylene glycol, mannitol, sodium chloride, and an amino acid, wherein the formulation is a buffered aqueous solution having a pH of 4.5 to 7.6. The present invention also provides an immunoconjugate formulation that is substantially free of aggregates, the immunoconjugate formulation comprising: an immunoconjugate and one or more excipients selected from the group consisting of histidine, sucrose, glycine and sodium chloride, wherein the formulation is a buffered aqueous solution having a pH of 4.5 to 7.6. The present invention further provides an immunoconjugate formulation that is substantially free of both particles and aggregates.
    • 本发明提供了基本上不含颗粒的免疫偶联物制剂,所述免疫偶联物制剂包含:免疫偶联物和一种或多种选自以下的赋形剂:蔗糖,聚山梨醇酯20,聚山梨醇酯80,环糊精,右旋糖,甘油,聚乙二醇, 甘露醇,氯化钠和氨基酸,其中所述制剂是pH为4.5至7.6的缓冲水溶液。 本发明还提供了基本上不含聚集体的免疫缀合物制剂,免疫缀合物制剂包含:免疫偶联物和一种或多种选自组氨酸,蔗糖,甘氨酸和氯化钠的赋形剂,其中所述制剂是缓冲水溶液 pH为4.5至7.6。 本发明还提供基本上不含颗粒和聚集体的免疫偶联物制剂。