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Formes posologiques à libération contrôlée enchâssées et inviolables
专利权人:
Purdue Pharma L.P.
发明人:
申请号:
EP14186661.6
公开号:
EP2826468A1
申请日:
2011.12.21
申请国别(地区):
EP
年份:
2015
代理人:
摘要:
In certain embodiments, the present invention is directed to a solid controlled release dosage form comprising: a core comprising a first portion of an opioid analgesic dispersed in a first matrix material; and a shell encasing the core and comprising a second portion of the opioid analgesic dispersed in a second matrix material; wherein the opioid analgesic is selected from the group consisting of hydrocodone, pharmaceutically acceptable salts thereof, hydrates thereof, solvates thereof, and mixtures thereof; wherein the amount of opioid analgesic 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.
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来源网址:
http://www.ckcest.cn/home/
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