CRYSTALLINE FORMS OF A 3-PYRROLE SUBSTITUTED 2-INDOLINONE MALATE SALT

Disclosed are crystalline polymorphic forms of the malic acid salt of (Z)-N-[2- (diethylamino)ethyl]-5-[(5-fluoro-l,2-dihydro-2-oxo-3H-indol-3-yliden)methyl]-2,4- dimethyl-1H-pyrrole-3-carboxamide, sunitinib malate, including crystalline Forms III, IV, V, VI and VII. Also disclosed are processes for...

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Bibliographische Detailangaben
Hauptverfasser: WINTER, STEPHEN, BENEDICT, DAVID, BENITO VELEZ, MONICA
Format: Patent
Sprache:eng ; fre ; ger
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Zusammenfassung:Disclosed are crystalline polymorphic forms of the malic acid salt of (Z)-N-[2- (diethylamino)ethyl]-5-[(5-fluoro-l,2-dihydro-2-oxo-3H-indol-3-yliden)methyl]-2,4- dimethyl-1H-pyrrole-3-carboxamide, sunitinib malate, including crystalline Forms III, IV, V, VI and VII. Also disclosed are processes for preparing crystalline polymorphic forms of sunitinib malate and pharmaceutical compositions comprising sunitinib malate.