Polymorphic Forms of Afatinib Dimaleate

The present disclosure relates to amorphous and crystalline forms of 2-butenamide, N-[4-[(3-chloro-4-fluorophenyl)amino]7-[[(3S)-tetrahydro-3-furanyl]oxy]-6-quinazolinyl]-4-(dimethyl amino)-,(2E)-, (2Z)-2-butenedioate (1:2) (afatinib dimaleate). The present disclosure also relates to process for the...

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Main Authors Sarbajna Ruchira M, Arikatla Sivalakshmidevi, Gorantla Asharani, Jetti Ramakoteswara Rao, Indukuri Anjaneyaraju, Beeravelly Satish, Ramireddy B.A
Format Patent
LanguageEnglish
Published 01.02.2018
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Summary:The present disclosure relates to amorphous and crystalline forms of 2-butenamide, N-[4-[(3-chloro-4-fluorophenyl)amino]7-[[(3S)-tetrahydro-3-furanyl]oxy]-6-quinazolinyl]-4-(dimethyl amino)-,(2E)-, (2Z)-2-butenedioate (1:2) (afatinib dimaleate). The present disclosure also relates to process for the preparation of amorphous and crystalline forms of afatinib dimaleate. Further, the present disclosure relates to solid dispersion of amorphous afatinib dimaleate and the crystalline form of afatinib.
Bibliography:Application Number: US201615225015