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fenofibrate formulation
专利权人:
INC.;MYLAN
发明人:
ANDREW ALAN SHAW,GLENN ALLEN REDELMAN,SARAT C. CHATTARAJ
申请号:
BR112014032513
公开号:
BR112014032513A2
申请日:
2012.10.23
申请国别(地区):
BR
年份:
2017
代理人:
摘要:
fenofibrate dosage forms contain a plurality of beads or particles, where the beads or particles include a pharmaceutical composition comprising fenofibrate; from 0.3% to 10% by weight of the beads or particles of a surfactant; and from about 5% to about 15% by weight of the beads or particles of a water soluble or water dispersible cellulosic binder. the mass ratio of the drug to the binder in the dosage form is between 3.5: 1 and 4.5: 1; and the dosage form produces a first cmax in vivo which is between about 10% and about 50% higher than a comparative cmax produced by a comparative dosage form. the comparative dosage form comprises the drug and the binder in a ratio of between 5: 1 and 15: 1. "fenofibrate formulation" are various fenofibrate dosage forms containing a plurality of microspheres or particles, wherein the microspheres or particles include a pharmaceutical composition comprising fenofibrate; from 0.3% to 10% by weight of the microspheres or particles of a surfactant; and from about 5% to about 15% by weight of the microspheres or particles of a water-soluble or water-dispersible cellulosic binder. the mass ratio of the drug to the binder in the dosage form is between about 3.5: 1 and 4.5: 1; and the dosage form produces a first in vivo max which is between about 10% and about 50% greater than a comparative max. produced by a comparative dosage form. The comparative dosage form comprises the drug and the binder in a ratio of about 5: 1 to 15: 1.abstract various fenofibrate dosage forms contain a plurality of beads or particles, where the beads or particles include a pharmaceutical composition comprising fenofibrate; from 0.3% to 10% by weight of the beads or particles of a surfactant; and from about 5% to about 15% by weight of the beads or particles of a water soluble or water dispersible cellulosic binder. the mass ratio of the drug to the binder in the dosage form is between about 3.5:1 and 4.5:1; and the dosage form produces a first cmax in vivo th
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