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STABILIZED ANTIBODY-CONTAINING LIQUID FORMULATIONS

机译:稳定的含抗体的液体制剂

摘要

An objective of the present invention is to provide stable antibody-containing formulations which are suitable for subcutaneous administration and in which aggregation formation is suppressed during long-term storage. The present inventors discovered that a significant stabilization effect was achieved by using an acidic amino acid, aspartic acid or glutamic acid as a counter ion species in histidine buffer or tris(hydroxymethyl)aminomethane, specifically by using histidine-aspartate buffer or histidine-glutamate buffer, or tris(hydroxymethyl)aminomethane-aspartate or tris(hydroxymethyl)aminomethane-glutamate as a buffer. The present inventors also discovered that a significant stabilization effect was achieved by using an acidic amino acid, aspartic acid or glutamic acid, as a counter ion species to a basic amino acid such as arginine, specifically by using arginine-aspartate or arginine-glutamate.
机译:本发明的目的是提供适用于皮下给药的含稳定抗体制剂,并且在长期储存期间抑制了聚集形成。本发明人发现,通过使用组氨酸 - 天冬氨酸缓冲液或组氨酸 - 谷氨酸缓冲液,通过使用组氨酸缓冲液或TRIS(羟甲基)氨基甲烷的酸性氨基酸,天冬氨酸或谷氨酸作为反离子物质来实现显着的稳定效果。或Tris(羟甲基)氨基甲烷 - 天冬氨酸或Tris(羟甲基)氨基甲烷 - 谷氨酸作为缓冲液。本发明人还发现通过使用酸性氨基酸,天冬氨酸或谷氨酸,作为对碱性氨基酸如精氨酸的碱性氨基酸,特别是通过使用精氨酸 - 天冬氨酸或精氨酸 - 谷氨酸来实现显着的稳定效果。

著录项

  • 公开/公告号EP3378486B1

    专利类型

  • 公开/公告日2021-03-03

    原文格式PDF

  • 申请/专利权人 CHUGAI SEIYAKU KABUSHIKI KAISHA;

    申请/专利号EP20180155113

  • 发明设计人 IGAWA TOMOYUKI;MORIYAMA CHIFUMI;

    申请日2011-01-20

  • 分类号A61K39;A61K9/08;A61K9/19;A61K47/18;A61K47/26;A61K39/395;

  • 国家 EP

  • 入库时间 2022-08-24 17:29:06

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