发明公开
EP1501496A2 FORMULATIONS CONTAINING AMIODARONE AND SULFOALKYL ETHER CYCLODEXTRIN 有权
制剂含胺碘酮磺烷基醚环糊精

  • 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
  • 申请号: EP03728598.8
    申请日: 2003-04-29
  • 公开(公告)号: EP1501496A2
    公开(公告)日: 2005-02-02
  • 发明人: MOSHER, Gerold, L.JOHNSON, Karen, T.GAYED, Atef, A.
  • 申请人: Cydex Inc.
  • 申请人地址: Suite 470,12980 Metcalf Avenue Overland Park, KS 66213 US
  • 专利权人: Cydex Inc.
  • 当前专利权人: Cydex Inc.
  • 当前专利权人地址: Suite 470,12980 Metcalf Avenue Overland Park, KS 66213 US
  • 代理机构: Weber, Thomas Dr.
  • 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
FORMULATIONS CONTAINING AMIODARONE AND SULFOALKYL ETHER CYCLODEXTRIN
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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