A PROCESS FOR THE PREPARATION OF CARIPRAZINE HYDROCHLORIDE

The present invention is directed towards a process for the preparation of Cariprazine (Ia) or a pharmaceutically acceptable salt thereof, wherein, N,N- dimethyl-1H-imidazole-1-carboxamide alkyl halide (VII) is reacted with trans-4- (2-(4-(2,3-dichlorophenyl)piperazin-1-yl)ethyl)cyclohexanamine or a...

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Hauptverfasser: NEELA, Praveen Kumar, SANKINENI, Sampath Kumar, BATTHINI, Guruswamy, MADDI, Raghavender Reddy, BINGI, Hariprasad Reddy, MEENAKSHISUNDERAM, Sivakumaran
Format: Patent
Sprache:eng ; fre
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Zusammenfassung:The present invention is directed towards a process for the preparation of Cariprazine (Ia) or a pharmaceutically acceptable salt thereof, wherein, N,N- dimethyl-1H-imidazole-1-carboxamide alkyl halide (VII) is reacted with trans-4- (2-(4-(2,3-dichlorophenyl)piperazin-1-yl)ethyl)cyclohexanamine or a salt thereof (IIa) to produce Cariprazine (Ia) or a pharmaceutically acceptable salt thereof. The present invention is also directed towards amorphous form of Cariprazine hydrochloride (I) and solid dispersion of Cariprazine hydrochloride (I), and its preparation thereof. La présente invention concerne un procédé de préparation de cariprazine (Ia) ou d'un sel pharmaceutiquement acceptable de celle-ci, l'halogénure d'alkyle de N,N-diméthyl-1H-imidazole-1-carboxamide (VII) étant mis à réagir avec du trans-4-(2-(4-(2,3-dichlorophényl)pipérazin-1-yl)éthyl)cyclohexanamine ou un sel de celle-ci (IIa) pour produire la cariprazine (Ia) ou un sel pharmaceutiquement acceptable de celle-ci. La présente invention concerne également une forme amorphe du chlorhydrate de cariprazine (I) et une dispersion solide du chlorhydrate de cariprazine (I), ainsi qu'une préparation correspondante.