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Composition based on fexofenadine and preparation procedure for it
专利权人:
SANOFI
发明人:
LESOT, AXELLE,LAMOUREUX, GAËL
申请号:
ES11764289
公开号:
ES2527390T3
申请日:
2011.04.20
申请国别(地区):
ES
年份:
2015
代理人:
摘要:
Composition of fexofenadine comprising (a) a granular center formed by aggregates of active ingredient added in the presence of a binder and optionally a lubricant or preferably a diluent, and (b) a layer for coating said granular center formed by a fatty matrix , composition in which: fexofenadine represents at least 10%, preferably 15% or even 20% by weight relative to the weight of the composition; the active ingredient represents no more than 90%, preferably no more than 60% or 50% by weight in relation to the weight of the composition, or even less than 40% by weight in relation to the weight of the composition, preferably the active ingredient represents from 20% to 40% in relation to the weight of the composition; The fatty matrix represents from 50% to 85% by weight of the composition, the fatty matrix optionally comprising an adjuvant, preferably chosen from hydrophilic agents, surfactants or mixtures thereof, and these adjuvants representing less than 10% by weight of the composition. and preferably from 1% to 3% by weight relative to the weight of the composition; The binder, preferably a hydrophilic agent chosen from hydrophilic polymers and hot melting agents, represents from 0.2% to 18% by weight relative to the weight of the composition, preferably the binder represents less than 18% by weight for an agent. hot melt, or even, preferably, the binder represents less than 10% by weight for a hydrophilic polymer relative to the weight of the composition; the diluent, if necessary, as a filler material represents a content of 0 to 78.8%, preferably 0 to 39% and preferably 5% to 15% by weight in relation to the weight of the composition; The lubricant, if necessary, as a flow agent represents a content of 0 to 1.8% in relation to the weight of the composition.Composición de fexofenadina que comprende (a) un centro granular formado por granos de principio activo agregados en presencia de un aglutinante y opcionalmente de un lubricante o preferiblemente de un
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