oral formulations deferasirox
2014
A film-coated tablet for oral administration containing deferasirox or a pharmaceutically acceptable salt thereof in an amount 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 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 the total tablet weight, 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 crosslinked polyvinylpyrrolidone (crospovidone); (Iii) at least one binder in a total amount of 1% to 5% by weight based on the total tablet weight, 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; (V) at least one glidant in a total amount of 0.1% to 1% by weight based on the total weight of the tablet, wherein the glidant is colloidal silicon dioxide; (Vi) at least one lubricant in a total amount of less than 0.1% to 2% by weight based on the total weight of the tablet, wherein the lubricant is magnesium stearate; and (vii) a coating.
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