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PROCESS FOR THE PREPARATION OF A SOLID, ORALLY ADMINISTRABLE PHARMACEUTICAL COMPOSITION
专利权人:
发明人:
KLAUS BENKE
申请号:
IN2644/DELNP/2006
公开号:
IN256522B
申请日:
2006.05.11
申请国别(地区):
IN
年份:
2013
代理人:
摘要:
A Process for the preparation of a solid, orally administrable pharmaceutical composition comprising 5-chloro-N-({(5S)-2-oxo-3-[4-(3-oxo-4-morpholinyl)-phenyl]-l,3-oxazolidin-5-yl}-methyl)-2-thiophenecarboxamide (I) in hydrophilized form, characterized in that (a) first granules comprising the active compound (I) in hydrophilized form are prepared by moist granulation, wherein the active compound (I) is treated with the granulating liquid containing a solvent, a hydrophilic binding agent, and an optional wetting agent, wherein the granulating liquid, the solvent, the hydrophilic binding agent and the wetting agent are of the kind such as herein described, (b) and the granules, wherein the active compound (I) is present in a concentration of 0.1 to 60%, the wetting agent is present in a concentration of 0.1 to 5% and the hydrophilic binding agent is present in a concentration of 1 to 15%, all concentrations based on the total mass of the formulation, are then converted into the pharmaceutical composition, if appropriate with addition of pharmaceutically suitable additives of the kind such as herein described.
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