发明授权
US08617568B2 Pharmaceutical liquid composition of botulinum toxin with improved stability
有权
肉毒杆菌毒素的药物液体组合物具有改善的稳定性
- 专利标题: Pharmaceutical liquid composition of botulinum toxin with improved stability
- 专利标题(中): 肉毒杆菌毒素的药物液体组合物具有改善的稳定性
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申请号: US12666592申请日: 2008-05-28
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公开(公告)号: US08617568B2公开(公告)日: 2013-12-31
- 发明人: Hyun Ho Jung , Gi Hyeok Yang , Hack Woo Kim , Hee Dong Woo , Chang Hoon Rhee
- 申请人: Hyun Ho Jung , Gi Hyeok Yang , Hack Woo Kim , Hee Dong Woo , Chang Hoon Rhee
- 申请人地址: KR
- 专利权人: Medy-Tox, Inc.
- 当前专利权人: Medy-Tox, Inc.
- 当前专利权人地址: KR
- 代理机构: Riverside Law LLP
- 优先权: KR10-2007-0069363 20070710
- 国际申请: PCT/KR2008/002975 WO 20080528
- 国际公布: WO2009/008595 WO 20090115
- 主分类号: A61K39/08
- IPC分类号: A61K39/08
摘要:
Disclosed herein is a liquid pharmaceutical composition of botulinum toxin which is improved in stability. It comprises botulinum toxin, polysorbate 20, and methionine and optionally isoleucine. Employing, instead of the animal-derived protein albumin or gelatin, a combination of polysorbate 20 and methionine and optionally isoleucine as botulinum toxin stabilizers, the liquid pharmaceutical composition eliminates the risk of contaminating the body with serum-derived pathogens or microorganisms and can be administered safely to the body. Also, the composition is convenient for use as a direct injection for patients. Superior to conventional compositions employing either detergents or amino acids in terms of the storage stability of botulinum toxin at 25˜370C as well as at refrigerated temperatures, the liquid pharmaceutical composition of the present invention is very useful for storing botulinum toxin under an emergency condition such as an environment without maintaining low temperature. The liquid pharmaceutical composition can be readily prepared because it employs a detergent and an amino acid(s) without a lyophilization process.
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