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Pharmaceutical composition and corresponding galenic form of rapid dispersion in the mouth, and manufacturing process of this composition
专利权人:
Physica Pharma
发明人:
BROUSSAUD, Olivier,POUGNAS, Jean-Luc,CALVET, Nicolas
申请号:
ES06709077
公开号:
ES2615509T3
申请日:
2006.01.12
申请国别(地区):
ES
年份:
2017
代理人:
摘要:
Powdery pharmaceutical composition used to constitute after compression a rapid dispersion galenic form in the mouth, said composition including solid particles based on a mixture of excipients that includes at least one diluent chosen from a dextrin, a maltodextrin, lactose, sucrose, trehalose, mannitol, sorbitol, erythritol, maltitol, lactitol and fructose, said particles being coated with a film based on an aqueous colloidal solution that is intended to prehydrate said composition, so that said particles thus coated are free from each other others in said composition, said colloidal solution including a self-emulsifying system including in combination at least one hydrophilic film-forming compound, at least one lubricating amphiphilic compound, and at least one wetting amphiphilic compound, in which: - said at least hydrophilic film-forming compound is a carbohydrate chosen from group c constituted by maltodextrins, dextrins, sorbitol, mannitol and xylitol or a polyethylene glycol with a weight average molecular mass Mw ranging from 1000 g / mol to 6000 g / mol, - said at least lubricating amphiphilic compound is chosen from the group consisting of lauryl ether sulfate sodium, sodium lauryl sulfate, and magnesium stearate, and - said at least wetting amphiphilic compound is chosen from a lauroyl macrogolglyceride, such as a lauroyl macrogol-32 glyceride (Gelucire®44 / 14), and a stearoyl macrogolglyceride, such as a stearoyl macrogol-32 glyceride (Gelucire® 50/13), and in which the mass ratio of colloidal solution / particles intended to receive said colloidal solution is less than or equal to 10%.Composición farmacéutica pulverulenta utilizada para constituir después de la compresión una forma galénica de dispersión rápida en la boca, incluyendo dicha composición partículas sólidas a base de una mezcla de excipientes que incluye al menos un diluyente elegido entre una dextrina, una maltodextrina, lactosa, sacarosa, trehalosa, manitol, sorbitol, eritritol, maltit
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