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Formulation of ceritinib
专利权人:
NOVARTIS AG
发明人:
申请号:
ARP150101661
公开号:
AR100625A1
申请日:
2015.05.27
申请国别(地区):
AR
年份:
2016
代理人:
摘要:
This description refers to a Pharmaceutical composition comprising ceritinib. In particular is a Tablet which is prepared by Wet granulation, povidone, where it is used as a Binder.An additional feature of the composition is that the Drug and the Binder are the internal Phase, while all the other excipients are added in powder form as an external phase. This prevents the adhesion of the composition and can achieve enough hardness of the tablet.Claim 1: a Pharmaceutical composition comprising more than 40% and up to 70% by weight of ceritinib based on the total weight of the pharmaceutical composition. Claim 3: the pharmaceutical composition according to claim 1 which comprises a granule comprising ceritinib and a Binder, where the granule is obtainable by Wet granulation.Claim 12: a Tablet comprising ceritinib obtainable by (i) preparation of Granules comprising a Binder and ceritinib by Wet granulation, (ii) The Granules mixed with at least one other Pharmaceutical excipient to obtain a mixture, and (iii) to compress the mixture pair To obtain the tablet.Claim 14: the pharmaceutical composition according to any one of claims 1 to 11, or the tablet according to claim 11 or 12, where a dose of ceritinib is at least 150 and 750 mg, preferably a dose of ceritinib is at least 150 to 375 mg, M More preferably is at least 375 mg to 300 mg and, in particular ceritinib is a dose of 300 mg.La presente descripción se refiere a una composición farmacéutica que comprende Ceritinib. En particular se dirige a la tableta que se prepara por granulación húmeda, en donde se utiliza povidona como aglutinante. Una característica adicional de la composición es que el fármaco y el aglutinante forman la fase interna, mientras que todos los otros excipientes se añaden en forma de polvo como una fase externa. De esta manera, se evita la adherencia de la composición y se puede lograr una dureza suficiente de la tableta. Reivindicación 1: Una composición farmacéutica que comprende más de 40%
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