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ENCASED TAMPER RESISTANT CONTROLLED RELEASE DOSAGE FORMS
专利权人:
PURDUE PHARMA LP
发明人:
HUANG HAIYONG HUGH
申请号:
AP2013006907
公开号:
AP3815A
申请日:
2011.12.21
申请国别(地区):
AP
年份:
2016
代理人:
摘要:
In certain embodiments, the present invention is directed to 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 inner 50% of the dosage form contains at least 80% of the hydrocodone or salt thereof; 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.
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