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IMMEDIATE RELEASE DRUG FORMULATION COMBINING OPIOID AND NONOPIOID ANALGESICS WITH ABUSE DETERRENCE AND OVERDOSE PROTECTION
专利权人:
KASHIV PHARMA LLC
发明人:
VAKA, Siva, Ram Kiran,MEGHPARA, Kanji,DESAI, Dipen,PHUAPRADIT, Wantanee,SHAH, Navnit, H.,THONGSUKMAK, Atsawin
申请号:
USUS2017/030667
公开号:
WO2017/192608A1
申请日:
2017.05.02
申请国别(地区):
WO
年份:
2017
代理人:
摘要:
The present disclosure provides solid immediate release (IR) dosage forms, including particulate and multi-particulate dosage forms, with abuse deterrent and overdose protection characteristics. In certain embodiments, the dosage form is multi¬ particulate, comprising: a first population of particulates comprising a therapeutically effective amount of at least one opioid embedded in a polymer matrix, an optional seal coat, a functional coat layer(s), and an over coat, wherein the functional coat layer(s) comprises a nonionic water-insoluble polymer, and a cationic polymer that dissolves at a pH of less than about 5 a second population of particulates comprising a therapeutically effective amount of acetaminophen (APAP) embedded in a polymer matrix, an optional seal coat, a functional coat layer(s), and an over coat, wherein the functional coat layer(s) comprises a cationic polymer that dissolves at a pH of less than about 5 and an optional nonionic water-insoluble polymer and a third population of particulates comprising an alkaline agent, and an optional pH-stabilizing agent, wherein the alkaline agent raises the gastric pH when three or more dosage units are ingested, and the pH-stabilizing agent maintains the elevated pH. The dosage forms, including particulate and multi-particulate dosage forms, are designed to accomplish the desired combination of analgesia, abuse deterrence, and overdose protection.La présente invention concerne des formes posologiques solides à libération immédiate (IR), qui comprennent des formes posologiques particulaires et multiparticulaires, dotées de caractéristiques de protection contre les abus et de protection contre le surdosage. Dans certains modes de réalisation, la forme posologique est multiparticulaire, et comporte : une première population de particules comportant une quantité thérapeutiquement efficace dau moins un opioïde incorporée dans une matrice polymère, un revêtement de scellement facultatif, une ou plusieurs couche(s)
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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