BRPI0809838A2

Method for improving the stability of clopidogrel using sulfoalkyl ether cyclodextrin

Abstract

The present invention relates to clopidogrel-containing compositions, which are present as a free base or a pharmaceutically acceptable salt thereof, in which the amount of clopidogrel is present in the composition, and sulfoalkyl ether cyclodextrin (sae-cd). the compositions may be liquid compositions, suspensions or solids. they may be adapted for oral, perioral or parenteral administration. sae-cd serves to dissolve and stabilize clopidogrel in aqueous medium. the stability of clopidogrel against hydrolytic degradation, thermal degradation and photolytic degradation are improved. the sae-cd shows better results with respect to the cyclodextrin derivatives. the sae-cd containing composition of clopidogrel may be provided in liquid form, solid form or as a reconstitutable powder. both the ready-to-use compositions and the concentrated liquids can be prepared. the liquid composition is optionally available as a clear solution. the compositions herein may be administered periorally or parenterally and provide substantial pharmacokinetic, pharmacodynamic and / or therapeutic advantages over the periorally administered tablet compositions and excluding sae-cd.

Term

1.6 yearsleft in the term

Expires 26 April 2028.

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Priority claims
DocumentOfficeKindDate
60914555United States of America
91455507United States of AmericaP
91455507United States of AmericaP
2008061697United States of AmericaW
2008061697United States of AmericaW
60914555
PCTUS2008061697
US20070914555P
WO2008US61697

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