Polymorphs of fexofenadine hydrochloride

C - Chemistry – Metallurgy – 07 – D

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Details

C07D 211/22 (2006.01) A61K 31/445 (2006.01) A61P 37/08 (2006.01)

Patent

CA 2444456

The present invention provides novel crystal forms of fexofenadine hydrochloride Forms (V, VI and VIII through XV) and processes for their preparation and preparation of amorphous form and other crystalline forms of fexofenadine hydrochloride. Forms (XIV and XV) are solvates of ethyl acetate, while Form IX is anhydrous, but can be crystallized as solvate of MTBE or cyclohexane. The forms are useful for administration to humans and animals to alleviate symptoms caused by histamine. The present invention further provides pharmaceutical compositions of the new crystalline forms.

L'invention concerne de nouvelles formes cristallines de chlorhydrate de fexofénadine formes V, VI et VIII en passant par XV et leur procédé de préparation, ainsi qu'un procédé de préparation de forme amorphe et d'autres formes cristallines de chlorhydrate de fexofénadine. Les formes XIV et XV sont des solvates d'acétate d'éthyle, alors que la forme IX est un anhydre, mais il peut être cristalliser comme un solvate d'éther méthyltertiobutylique ou de cyclohexane. Ces formes sont utilisées dans l'administration à des humains et à des animaux afin d'atténuer les symptômes provoqués par l'histamine. Cette invention concerne enfin des compositions pharmaceutiques de ces nouvelles formes cristallines.

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