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New modified release dosage forms of xanthine oxidoreductase inhibitor or xanthine oxidase inhibitors
专利权人:
Inc.;Takeda Pharmaceuticals U.S.A.
发明人:
TANEJA, Rajneesh,GUPTE, Vijay,VAKILYNEJAD, Majid
申请号:
ES11796331
公开号:
ES2669184T3
申请日:
2011.06.15
申请国别(地区):
ES
年份:
2018
代理人:
摘要:
A modified-release pharmaceutical composition comprising febuxostat immediate release microspheres in an amount ranging from 20% to 40% (w / w) of the total weight of the composition and delayed release febuxostat microspheres having a solubility at levels of pH greater than or equal to 6.8 in an amount ranging from 60% to 80% (w / w) of the total weight of the composition, wherein said immediate release microspheres comprise (a) an inert core in an amount that ranges from 50% to 55% (w / w) of the weight of the immediate release microsphere, and (b) an immediate release layer that encapsulates the inert core comprising a mixture of febuxostat and hydroxypropyl methylcellulose in an amount that varies from 45% to 50% (w / w) of the weight of the immediate release microsphere, the ratio of febuxostat to hydroxypropyl methylcellulose ranges from 1.5 to 3; and wherein said delayed release microspheres comprise (a) an inert core in an amount ranging from 40.5% to 43% (w / w) of the weight of the delayed release microsphere, (b) an immediate release layer encapsulating the inert core comprising a mixture of febuxostat and hydroxypropyl methylcellulose in an amount ranging from 35% to 40% (w / w) of the weight of the delayed release microsphere, the ratio of febuxostat to hydroxypropyl methylcellulose varies from 1 , 5 to 3, (c) an enteric delayed release polymer layer that encapsulates the immediate release layer comprising an enteric delayed release polymer in an amount ranging from 17% to 20% (w / w) of the microsphere of delayed release, said enteric delayed release polymer comprises a mixture of type A methacrylic acid copolymer and type B methacrylic acid copolymer in a ratio ranging from 0.1 to 0.5, and (d) a plastific before in an amount ranging from 1% to 3% (w / w) of the weight of the delayed and controlled microsphere, said plasticizer comprises triethyl citrate.Una composición farmacéutica de liberación modificada que comprende microesferas de febuxostat de l
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