发明授权
- 专利标题: FORMULATIONS CONTAINING AMIODARONE AND SULFOALKYL ETHER CYCLODEXTRIN
- 专利标题(中): 制剂含胺碘酮磺烷基醚环糊精
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申请号: EP03728598.8申请日: 2003-04-29
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公开(公告)号: EP1501496B1公开(公告)日: 2011-11-30
- 发明人: MOSHER, Gerold, L. , JOHNSON, Karen, T. , GAYED, Atef, A.
- 申请人: CyDex Pharmaceuticals, Inc.
- 申请人地址: 10513 W. 84th Terrace Lenexa, KS 66214 US
- 专利权人: CyDex Pharmaceuticals, Inc.
- 当前专利权人: CyDex Pharmaceuticals, Inc.
- 当前专利权人地址: 10513 W. 84th Terrace Lenexa, KS 66214 US
- 代理机构: von Kreisler Selting Werner
- 优先权: US139620 20020504
- 国际公布: WO2003092590 20031113
- 主分类号: A61K31/343
- IPC分类号: A61K31/343 ; A61K31/724 ; A61K49/00
摘要:
The present invention provides aqueous parenteral formulations containing an antiarrhythmic agent, such as amiodarone, and a sulfoalkyl ether cyclodextrin. The liquid formulations are clear, sterilizable, and chemically and physically stable. The liquid formulations do not require a surfactant and do not precipitate upon dilution with distilled water or other pharmaceutically acceptable liquid carrier. The sulfoalkyl ether cyclodextrin-containing formulation provides significant advantages over other cyclodextrin-containing formulations of amiodarone. The formulation can be prepared in acidic, neutral and slightly basic medium while providing acceptable concentrations of amiodarone suitable for parental administration. An SAE-CD-containing formulation of amiodarone can be provided in liquid form or as a reconstitutable powder. Moreover, highly concentrated solutions exceeding 200 mg of amiodarone per mL can be prepared. Solutions can be made either dilutable or non-dilutable with water at room temperature or under conditions typically encountered in the clinic.
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