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固體分散物的固形製劑及其製造方法
专利权人:
发明人:
HOSHINO, TAKAFUMI,星野贵史,星野貴史,KUSAKI, FUMIE,草木史枝,草木史枝,MARUYAMA, NAOSUKE,丸山直亮,丸山直亮,NISHIYAMA, YUICHI,西山裕一,西山裕一,FUKUI, IKUO,福井育生,福井育生,UMEZAWA, HIROSHI,梅泽宏,梅澤宏
申请号:
TW096129038
公开号:
TWI468178B
申请日:
2007.08.07
申请国别(地区):
TW
年份:
2015
代理人:
摘要:
Provided are a solid dosage form comprising a solid dispersion that allows a drug in the preparation to be rapidly dissolved without compromising the solubility of the solid dispersion, and a method for producing the same. More specifically, provided is a solid dosage form comprising a solid dispersion, the dispersion comprising: a poorly soluble drug, a water-soluble polymer and a disintegrant, wherein the disintegrant is low-substituted hydroxypropylcellulose having an average particle size of 10 to 100 µ m and a specific surface area measured by BET method of at least 1.0 m 2 /g. Moreover, provided is a method for producing a solid dosage form comprising a solid dispersion, the method comprising steps of: spraying a water-soluble polymer solution in which a poorly soluble drug has been dispersed or dissolved, on a powder of low-substituted hydroxypropylcellulose having an average particle size of 10 to 100 µm and a specific surface area measured by BET method of at least 1.0 m 2 /g and serving as a disintegrant and granulating the resultant and drying.本發明係提供不損及固體分散物之溶出性,可迅速地溶出製劑中藥物之固體分散物的固形製劑及其製造方法。提供含難溶性藥物、水溶性聚合物及崩壞劑之固體分散物的固體製劑,該崩壞劑係平均粒子徑為10~100 μm,而且,以BET(Brunauer,Emmett,Teller)法測定之比表面積為1.0m2/g以上之低取代度羥丙基纖維素之固體分散物的固形製劑。另外,提供包含於混合作為崩壞劑之平均粒子徑為10~100 μm,而且,以BET法測定比表面積為1.0m2/g以上之低取代度羥丙基纖維素之粉末,噴霧分散或溶解難溶性藥物之水溶性聚合物溶液,進行造粒、乾燥而成之固體分散物的固形製劑之製造方法。
来源网站:
中国工程科技知识中心
来源网址:
http://www.ckcest.cn/home/

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