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antifungal composition
专利权人:
BASILEA PHARMACEUTICA AG
发明人:
BUCHER, CHRISTIAN,DITZINGER, GÜNTER,DUBOIS, ESTELLE,MARCHAUD, DELPHINE
申请号:
ES08787353
公开号:
ES2551125T3
申请日:
2008.08.20
申请国别(地区):
ES
年份:
2015
代理人:
摘要:
A pharmaceutical composition for oral administration that is self-emulsifying upon contact with an aqueous phase, in particular gastrointestinal fluids, and comprising: (a) an antifungal active compound of formula (I): ** Formula ** in which: R1 and R3 are F and R2 is hydrogen or R1 and R2 are F and R3 is hydrogen or a pharmaceutically acceptable acid addition salt thereof and (b) a carrier comprising a solubilizing component for the antifungically effective component (a) and with a HLB value of less than 20, said solubilizing component comprising a mixture of: (b1) a mixture of glycerol mono-, di- and / or tri-esters and of polyethylene glycol mono- and / or diesters with at least one fatty acid selected from the group comprising C8-C18 fatty acids and (b2) a mixture of glycerol mono-, di- and / or tri-esters and polyethylene glycol mono- and / or diesters with caprylic acid and capric acid, in which the compound antifungal active formula (I) ol A pharmaceutically acceptable acid addition salt thereof is present in an amount of 2 to 20 percent by weight based on the total composition and one of the component (b1) or (b2) is present in an amount of 50 or greater than 50 weight percent based on total composition.Una composición farmacéutica para administración oral que es auto-emulsionante al contacto con una fase acuosa, en particular fluidos gastrointestinales, y que comprende: (a) un compuesto antifúngicamente activo de fórmula (I):**Fórmula** en la que: R1 y R3 son F y R2 es hidrógeno o R1 y R2 son F y R3 es hidrógeno o una sal de adición de ácido farmacéuticamente aceptable del mismo y (b) un portador que comprende un componente solubilizante para el componente (a) antifúngicamente eficaz y con un valor de HLB menor que 20, comprendiendo dicho componente solubilizante una mezcla de: (b1) una mezcla de mono-, di- y/o triésteres de glicerol y de mono- y/o diésteres de polietilenglicol con al menos un ácido graso elegido del grupo que comprende ácidos grasos C8-C18
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