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COMPOSITION PHARMACEUTIQUE A PHASE LIQUIDE UNIQUE STABILISEE CONTENANT DU DOCETAXEL
专利权人:
DONG-A PHARM.CO.; LTD.
发明人:
YOO, MOO-HI,CHA, BONG-JIN,KIM, JEONG-HOON,JANG, SUN-WOO,WON, DONG-HAN
申请号:
CA2714942
公开号:
CA2714942C
申请日:
2009.02.26
申请国别(地区):
CA
年份:
2014
代理人:
摘要:
This invention relates to a single-liquid pharmaceutical composition forinjection containing docetaxel. The composition includes (A) docetaxel andpharmaceutically acceptable salts thereof, (B) a surfactant selected from thegroupconsisting of polysorbate, polyoxyethylene glycol ester and polyoxyethylenecastor oilderivatives, (C) a solvent comprising anhydrous ethanol in a concentrationrange of 100to 800 mg/ml in an injectable solution, and (D) a pH adjuster of an amountsuitable foradjusting the pH of the liquid composition to 5 or less. The composition maybe directlydiluted in a perfusion liquid even without the use of an intermediary dilutesolution incase the composition is used for injectable preparations since the compositionis in asingle liquid phase. Furthermore, the composition is suitable for effectiveadministrationof docetaxel since the pharmaceutical stability of the composition issignificantlyimproved.
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