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Peroral solid dosage form extended release pharmaceutical dosage form
专利权人:
普渡製藥公司;PURDUE PHARMA L.P.;普渡制药公司
发明人:
MANNION, Richard, Owen,理查德.欧文.曼尼恩,理查德.歐文.曼尼恩,O'DONNELL, Edward, Patrick,爱德华.帕特里克.奥唐奈,愛德華.帕特裏克.奧唐奈,McKENNA, William, Henry,威廉.亨利.麦克纳,威廉.亨利.麥克納,HUANG, Haiyong, Hugh,黄海涌,黃海涌
申请号:
MOJ003729
公开号:
MOJ003729B
申请日:
2019.06.21
申请国别(地区):
MO
年份:
2019
代理人:
摘要:
The present invention relates to the Peroral solid dosage form extended release pharmaceutical dosage forms comprising opioid analgesic. The present invention provides a kind of Peroral solid dosage form extended release pharmaceutical dosage form,The extended release matrix formulations containing activating agent comprising tablet or more particle forms,Tablet or individual multi particulate can at least be crushed without broken,Be crushed Hou tablet or individual multi particulate the suitable what of thickness be crushed before tablet or individual multi particulate thickness no more than about 60%,And wherein when using USP device 1 (basket method) measurement in simulate the gastric juice (SGF) of the what 900ml containing 40% or 0% ethyl alcohol but without enzyme at 100rpm and 37 C,It is crushed or dissolution rate in vitro that the tablet not being crushed or more particles provide is the activating agent of 0.5 hour Hou release 5wt% to 40wt%.本發明涉及包含阿片類鎮痛劑的固體口服延長釋放藥物劑型。本發明提供一種固體口服延長釋放藥物劑型,包含片劑或多顆粒形式的含有活性劑的延長釋放基質製劑,片劑或獨立多顆粒可至少被壓扁而不破碎,被壓扁後片劑或獨立多顆粒的厚度相當於被壓扁前片劑或獨立多顆粒厚度的不超過約60%,並且其中當採用USP裝置1(籃法)在100rpm和37˚C下於900ml含40%或0%乙醇但不含酶的模擬胃液(SGF)中測量時,被壓扁或未被壓扁的片劑或者多顆粒提供的體外溶出速率是0.5小時後釋放5wt%至40wt%的活性劑。
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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