Invention Grant
- Patent Title: Solution preparation containing stabilized antibody
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Application No.: US16008486Application Date: 2018-06-14
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Publication No.: US11612562B2Publication Date: 2023-03-28
- Inventor: Tomoyuki Igawa , Chifumi Moriyama
- Applicant: Chugai Seiyaku Kabushiki Kaisha
- Applicant Address: JP Tokyo
- Assignee: Chugai Seiyaku Kabushiki Kaisha
- Current Assignee: Chugai Seiyaku Kabushiki Kaisha
- Current Assignee Address: JP Tokyo
- Agency: Nixon & Vanderhye P.C.
- Priority: JP2010-010060 20100120
- Main IPC: A61K39/395
- IPC: A61K39/395 ; A61K9/00 ; A61K47/12 ; A61K47/18 ; A61K47/26 ; A61K9/19

Abstract:
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.
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.
Public/Granted literature
- US20180344630A1 SOLUTION PREPARATION CONTAINING STABILIZED ANTIBODY Public/Granted day:2018-12-06
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