发明公开
- 专利标题： FORMULATIONS OF GROWTH HORMONE RELEASING FACTOR (GRF) MOLECULES WITH IMPROVED STABILITY
- 专利标题（中）： 配制剂GR-分子稳定性改进
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申请号： EP14756414.0申请日： 2014-02-26
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公开(公告)号： EP2961432A1公开(公告)日： 2016-01-06
- 发明人: SHINGEL, Kirill , FLEURY, Daniel
- 申请人： THERATECHNOLOGIES INC.
- 申请人地址： 2015 Peel Street, 5th Floor Montreal, QC H3A 1T8 CA
- 专利权人： THERATECHNOLOGIES INC.
- 当前专利权人： THERATECHNOLOGIES INC.
- 当前专利权人地址： 2015 Peel Street, 5th Floor Montreal, QC H3A 1T8 CA
- 代理机构： Brevalex
- 优先权： US201361771244P 20130301; US201313803712 20130314
- 国际公布： WO2014131122 20140904
- 主分类号： A61K47/40
- IPC分类号： A61K47/40 ; A61K38/25 ; A61K9/19
摘要：
Stabilized solid and liquid pharmaceutical formulations comprising a GRF molecule as active ingredient, such as GRF analogs including those comprising an N-terminal-attached hydrophobic moiety, such as [trans-3-hexenoyl]hGHRH (1-44) amide, are disclosed. The formulation comprises a GRF molecule or a pharmaceutically acceptable salt thereof and a β- cyclodextrin which is not conjugated to the GRF molecule or salt thereof. Also disclosed is the use of the formulation for the treatment of various conditions, methods of preparing the formulation, as well as kits containing it. Methods of stabilizing (e.g., with respect to chemical stability) such GRF molecules, as well as methods of inhibiting their deamidation at Asn
8 , are also disclosed.
8 , are also disclosed.
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