公开(公告)号：EP1501496A2

公开(公告)日：2005-02-02

申请号：EP03728598.8

申请日：2003-04-29

申请人： Cydex Inc.

发明人： MOSHER, Gerold, L. ,  JOHNSON, Karen, T. ,  GAYED, Atef, A.

IPC分类号： A61K31/343 ,  A61K31/724

CPC分类号： A61K49/0006 ,  A61K9/0019 ,  A61K31/343 ,  A61K47/10 ,  A61K47/12 ,  A61K47/18 ,  A61K47/6951 ,  B82Y5/00

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.