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Oral formulations of deferasirox
专利权人:
Novartis AG
发明人:
Ghosh, Indrajit,Zhang, Jia-Ai
申请号:
NZ71117914
公开号:
NZ711179A
申请日:
2014.03.06
申请国别(地区):
NZ
年份:
2018
代理人:
摘要:
The invention relates to compositions and technologies of manufacturing medicaments for desferasirox with high drug loading to potentially reduce variability of the gastric emptying, minimize food effect, prevent gastric irritation and also reduce the size and delivery route of the dosage form to improve patient compliance. In particular, disclosed is a tablet for oral administration which contains deferasirox or a pharmaceutically acceptable salt thereof present in an amount of from 45% to 60% by weight based on the total weight of the tablet, and wherein the tablet contains 90 mg, 180 mg or 360 mg of deferasirox or a pharmaceutically acceptable salt thereof, wherein the tablet further comprises, (i) at least one filler in a total amount of 10% to 40 % by weight based on total weight of the tablet, wherein the filler is microcrystalline cellulose (ii) at least one disintegrant in a total amount of 1% to 10% by weight based on the total weight of the tablet wherein the disintegrant is cross-linked polyvinylpyrrolidone (crospovidone) (iii) at least one binder in a total amount of about 1% to 5% by weight based on the total weight of the tablet, wherein the binder is polyvinylpyrrolidone (PVP) (iv) optionally,at least one surfactant in a total amount of 0.0% to 2% by weight based on the total weight of the tablet, wherein the surfactant is poloxamer.
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