DOSAGE FORMS OF TAFAMIDIS AND ITS PHARMACEUTICALLY ACCEPTABLE SALT THEREOF
摘要:
The disclosure relates to a novel dosage form comprising hard gelatin or HPMC capsule having granule composition, spray dried or evaporated composition comprising tafamidis or its pharmaceutically acceptable salt particularly tafamidis meglumine or solid-state forms or polymorphic forms of tafamidis particularly tafamidis free acid fumaric acid cocrystal and tablet comprising tafamidis or its pharmaceutically acceptable salt particularly tafamidis meglumine or solid-state forms or polymorphic forms of tafamidis particularly tafamidis free acid fumaric acid cocrystal that would not form a rigid gel upon contacting with water or buffer solution in dissolution specifically pH 6.8 phosphate buffer and that composition is indicated for the treatment of the cardiomyopathy of wild type or hereditary transthyretin-mediated amyloidosis in adults to reduce cardiovascular mortality and cardiovascular-related hospitalization.
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