SOLID DOSAGE FORMS OF TAFAMIDIS

The disclosure relates to a dosage form comprising a hard gelatin or a HPMC capsule having a granule composition comprising tafamidis or its pharmaceutically acceptable salt particularly tafamidis meglumine or solid-state forms or polymorphic forms of tafamidis particularly a solid-state form compri...

Ausführliche Beschreibung

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Bibliographische Detailangaben
Hauptverfasser: SIVAKUMAR, Palanisamy, SHANMUGAM, Muthusamy, SAKTHIKUMAR, Thirunavukkarasu, MADHUKAR, Singavarapu Ajay
Format: Patent
Sprache:eng
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Beschreibung
Zusammenfassung:The disclosure relates to a dosage form comprising a hard gelatin or a HPMC capsule having a granule composition comprising tafamidis or its pharmaceutically acceptable salt particularly tafamidis meglumine or solid-state forms or polymorphic forms of tafamidis particularly a solid-state form comprising tafamidis and fumaric acid. The disclosure also relates to a tablet comprising tafamidis or its pharmaceutically acceptable salt particularly tafamidis meglumine or solid-state forms or polymorphic forms of tafamidis particularly a solid-state form comprising tafamidis and fumaric acid. The solid dosage forms disclosed herein do not form a rigid gel upon contacting with water or buffer solution in dissolution specifically pH 6.8 phosphate buffer and the compositions disclosed herein are 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.