Title:
The liquefied tablet where etanercept was stabilized
Document Type and Number:
Japanese Patent JP5918850
Kind Code:
B2
Abstract:
The present invention relates to a stable liquid formulation of etanercept (recombinant p75 sTNFR:Fc fusion protein), and more particularly, to a liquid formulation comprising one or more stabilizers selected from the group consisting of methionine, lysine, histidine, and pharmaceutically acceptable salts thereof in an amount sufficient to reduce by-product formation of etanercept during storage. The liquid formulation according to the present invention effectively reduces production of etanercept by-products and to stably maintain its pharmaceutical efficacies for long-term storage. Therefore, the reconstitution procedure is not required before administration, and the sterile formulation can be administered to patients to ensure patient safety. Thus, it can be applied to the fields in need of etanercept treatment.
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Inventors:
Choi, Suk Yun
Ko, Yong Kyung
Seo, Ching On
Ko, Yong Kyung
Seo, Ching On
Application Number:
JP2014513452A
Publication Date:
May 18, 2016
Filing Date:
June 01, 2012
Export Citation:
Assignee:
LG LIFE SCIENCES LTD.
International Classes:
A61K39/395; A61K9/08; A61K47/02; A61K47/10; A61K47/12; A61K47/18; A61K47/20; A61K47/22; A61K47/26; A61P17/06; A61P19/02; A61P29/00; A61P37/02; A61P43/00
Domestic Patent References:
| JP2005527503A | ||||
| JP2009525986A | ||||
| JP2009155329A | ||||
| JP2011501671A |
Foreign References:
| WO2005082377A1 | ||||
| WO2012143418A1 | ||||
| WO2010106812A1 | ||||
| WO2010027364A1 |
Attorney, Agent or Firm:
Isshiki International Patent Service Corporation
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