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Encased tamper resistant controlled release dosage forms
专利权人:
PURDUE PHARMA L.P.
发明人:
Huang Haiyong Hugh
申请号:
NZ70872811
公开号:
NZ708728A
申请日:
2011.12.21
申请国别(地区):
NZ
年份:
2017
代理人:
摘要:
Disclosed is a solid controlled release dosage form comprising: a therapeutically effective amount of hydrocodone or a pharmaceutically acceptable salt thereof dispersed in a controlled release excipient; wherein the controlled release excipient comprises a material selected from the group consisting of polyethylene oxide, alkylcelluloses, acrylic and methacrylic acid polymers and copolymers, cellulose ethers, carboxyalkylcelluloses, waxes, and mixtures thereof; wherein the dosage form comprises an inner core and a shell encasing the core, wherein the weight ratio of the core to the shell is from about 1:0.5 to about 1:2; wherein the core comprises a first portion of the hydrocodone or pharmaceutically acceptable salt thereof dispersed in a first controlled release excipient, and the shell comprises a second portion of the hydrocodone or pharmaceutically acceptable salt thereof dispersed in a second controlled release excipient; wherein the inner 50 weight-% of the dosage form contains at least 80% of the hydrocodone or salt thereof; and wherein the amount of hydrocodone or salt thereof released from the dosage form is proportional within 20% to elapsed time from 8 to 24 hours, as measured by an in-vitro dissolution in a USP Apparatus 1 (basket) at 100 rpm in 900 ml simulated gastric fluid without enzymes (SGF) at 37°C.
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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