FORMULATION OF DEFERASIROX TABLET FOR ORAL SUSPENSION COMPOSITION WITH BETTER PROCESSABILITY

FORMULATION OF DEFERASIROX TABLET FOR ORAL SUSPENSION COMPOSITION WITH BETTER PROCESSABILITY

The invention relates to oral pharmaceutical composition comprising deferasirox or pharmaceutically acceptable salts, and at least one pharmaceutically acceptable excipient suitable for the preparation of tablets for oral suspension, wherein weight ratio of binder to disintegrant is about 1:10 - 1:1...

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Hauptverfasser: ÖNCEL, Hatice, PINARBAŞLI, Onur, ÇAPAN, Yilmaz, AKANSEL, Sibel, SARRAÇOĞLU, Nagehan
Format: Patent
Sprache:eng ; fre
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HUMAN NECESSITIES
HYGIENE
MEDICAL OR VETERINARY SCIENCE
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
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creator ÖNCEL, Hatice
PINARBAŞLI, Onur
ÇAPAN, Yilmaz
AKANSEL, Sibel
SARRAÇOĞLU, Nagehan
description The invention relates to oral pharmaceutical composition comprising deferasirox or pharmaceutically acceptable salts, and at least one pharmaceutically acceptable excipient suitable for the preparation of tablets for oral suspension, wherein weight ratio of binder to disintegrant is about 1:10 - 1:11 in order to produce deferasiroxinner phase having particle size distribution (D90)between 300 µm - 400 µm. The invention also relates to process for preparing said oral pharmaceutical compositions and its uses thereof. Also, the pharmaceutical formulation according to the invention is bioequivalent to the FDA approved product, Exjade® tablet for oral suspension according to a bioavailability study conducted in humans. L'invention concerne une composition pharmaceutique orale comprenant du déférasirox ou des sels pharmaceutiquement acceptables, et au moins un excipient pharmaceutiquement acceptable approprié pour la préparation de comprimés pour une suspension orale, le rapport pondéral du liant au délitant étant d'environ 1:10 à 1:11 afin de produire une phase interne de déférasirox ayant une distribution de taille de particule (D90) entre 300 µm et 400 µm. L'invention concerne également un procédé de préparation desdites compositions pharmaceutiques orales et ses utilisations. De plus, la formulation pharmaceutique selon l'invention est bioéquivalente au produit approuvé par la FDA, comprimé Exjade® pour suspension orale selon une étude de biodisponibilité effectuée chez l'être humain.
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subjects HUMAN NECESSITIES
HYGIENE
MEDICAL OR VETERINARY SCIENCE
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
title FORMULATION OF DEFERASIROX TABLET FOR ORAL SUSPENSION COMPOSITION WITH BETTER PROCESSABILITY
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