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Capsule pharmaceutical dosage form comprising a suspension formulation of an indolinone derivative
专利权人:
BOEHRINGER INGELHEIM INTERNATIONAL GMBH
发明人:
MESSERSCHMID ROMAN,BINDER RUDOLF,BOCK THOMAS,BROX WERNER
申请号:
NZ60316209
公开号:
NZ603162A
申请日:
2009.06.04
申请国别(地区):
NZ
年份:
2014
代理人:
摘要:
Disclosed is a viscous lipid suspension formulation of 3-Z-[1-(4-(N-((4-methyl-piperazin-1-yl)-methylcarbonyl)-N-methyl-amino)-anilino)-1-phenyl-methylene]-6-methoxycarbonyl-2-indolinone-monoethanesulphonate comprising a lipid carrier (such as acetylated monoglycerides, corn oil glycerides, ethyl oleate, glycerol mono/dioleate, glycerol monolinolate, macrogolglycerol caprylocaprate, macrogolglycerol linoleate, medium chain partial glycerides, medium chain triglycerides, caprylic-capric triglycerides, caprylic/capric/linoleic triglycerides, caprylic/capric/succinic triglycerides, propylene glycol dicaprylate/dicaprate, oleic acid, polyoxyl castor oil, polyoxyl hydrogenated castor oil, propylene glycol monocaprylate, propylene glycol monolaurate, refined animal derived oil, refined soybean oil, refined vegetable oil, sorbitan monostearate, or mixtures thereof), a thickener (such as semisolid highly viscous or solid polyethyleneglycols, oleogel forming excipients, lipophilic or amphiphilic excipients of high viscosity, and hard fats) and a glidant/solubilizing agent (i.e. lecithin). Also disclosed is a capsule comprising a capsule shell (such as a soft gelatine capsule, a hard gelatine, a hydroxypropylmethylcellulose (HPMC) capsule, a polyvinyl alcohol polymer capsule or a pullulan capsule) and a capsule formulation, wherein the capsule formulation comprises the formulation as defined above, and wherein the viscosity of the liquid system is a crucial parameter to ensure adequate drug release.
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