PROCESS FOR PREPARING NOVEL CRYSTALLINE FORMS OF PELIGLITAZAR, NOVEL STABLE FORMS PRODUCED THEREIN AND FORMULATIONS

A process is provided for selectively preparing novel stable crystalline forms, namely selectively and consistently preparing Form N-1 of the free acid peliglitazar, Form N-2 of the free acid peliglitazar and Form P-1 of the L-lysine salt of the free acid peliglitazar. The process preferably employs...

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Bibliographische Detailangaben
Hauptverfasser: KIM SOOJIN, PETSCH DEJAH T, WU YONGMEI, GOUGOUTAS JACK Z
Format: Patent
Sprache:eng
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Zusammenfassung:A process is provided for selectively preparing novel stable crystalline forms, namely selectively and consistently preparing Form N-1 of the free acid peliglitazar, Form N-2 of the free acid peliglitazar and Form P-1 of the L-lysine salt of the free acid peliglitazar. The process preferably employs solvent systems which produce crystals having suitable flow properties and desired particle size. Novel Form N-1 crystals of the free acid, Form N-2 crystals of the free acid, Form P-1 crystals of the L-lysine salt of the free acid, pharmaceutical compositions containing such novel forms and a method of treating diabetes, dyslipidemia and atherosclerosis employing such novel forms are also provided.