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QUICKLY DISPERSABLE GRANULES, ORAL DECOMPOSITION TABLETS AND METHODS
专利权人:
Инк. (US);Апталис Фарматек
发明人:
ВЕНКАТЕШ Гопи М. (US),СВАМИНАТАН Виджая (US),ЛАЙ Цзинь-Ван (US),КЛЭВЕНДЖЕР Джеймс М. (US)
申请号:
RU2013127593/15
公开号:
RU2013127593A
申请日:
2011.12.02
申请国别(地区):
RU
年份:
2015
代理人:
摘要:
1. A pharmaceutically acceptable, fast-dispersing composition in the form of microgranules with a median particle size in the range of from about 100 microns to about 300 microns, containing at least one sugar alcohol, saccharide or mixture thereof, at least one super-disintegrant and at least one multifunctional additive. . A fast-dispersing composition in the form of microgranules with a median particle size in the range from about 100 microns to about 300 microns, obtained by simple and quick granulation of a powder mixture containing: at least one sugar alcohol, saccharide or a mixture thereof, at least one super-disintegrant and at least one one pharmaceutically acceptable multifunctional additive in a ratio of approximately 88-98 (sugar alcohol): 1-10 (baking powder): 1-3 (multifunctional additive), in a fluidized bed granulator without c the need to grind wet granular products and / or prolonged grinding of dry granular product. 3. The fast-dispersing composition in the form of microgranules according to claim 1 or 2, wherein at least one sugar alcohol, saccharide or mixture thereof, at least one super-disintegrant and at least one multifunctional additive are present in a ratio of approximately 88-96 (sugar alcohol): 1-10 (baking powder): 1-3 (multifunctional additive) .4. A fast-dispersing composition in the form of microgranules according to claim 1 or 2, wherein the sugar alcohol is selected from the group consisting of mannitol, xylitol a, and a mixture thereof, the saccharide is selected from the group consisting of lactose, sucrose, fructose, and a mixture thereof. The fast-dispersing composition in the form of microgranules according to claim 1 or 2, where superrazry1. Фармацевтически приемлемая быстродиспергирующаяся композиция в форме микрогранул с медианным размером частиц в диапазоне от приблизительно 100 мкм до приблизительно 300 мкм, содержащая по меньшей мере один сахароспирт, сахарид или их смесь, по меньшей мере один суперразрыхлитель и по ме
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