发明名称 Tamper resistant dosage forms
摘要 The present invention relates to pharmaceutical dosage forms, for example to a tamper resistant dosage form including an opioid analgesic, and processes of manufacture, uses, and methods of treatment thereof.
申请公布号 US8894988(B2) 申请公布日期 2014.11.25
申请号 US201313900963 申请日期 2013.05.23
申请人 Purdue Pharma L.P.;Purdue Pharmaceuticals L.P. 发明人 McKenna William H.;Mannion Richard O.;O'Donnell Edward P.;Huang Haiyong H.
分类号 A61K9/20;A61K9/00;A61K9/28;A61K47/34;A61K31/485;A61K47/10;A61K9/16;A61J3/06;A61K9/24;A61K45/06 主分类号 A61K9/20
代理机构 Troutman Sanders LLP 代理人 Troutman Sanders LLP
主权项 1. A cured shaped tablet comprising an extended release matrix comprising a composition, wherein said tablet comprises: (1) at least one polyethylene oxide having, based on rheological measurements, an approximate molecular weight of 4,000,000, and (2) oxycodone or a pharmaceutically acceptable salt, andwherein said tablet is prepared by a process comprising the steps of: (a) combining at least (1) and (2) to form a blend; (b) shaping said blend to form a shaped tablet; and (c) curing said shaped tablet by subjecting the shaped tablet to a temperature from about 60 to about 90° C. for a time of from about 15 minutes to about 10 hours, wherein said cured shaped tablet comprises: (i) 5, 7.5, 10, 15, 20, or 30 mg of said oxycodone or pharmaceutically acceptable salt and at least 79% by weight, based upon the total weight of said composition, of said at least one polyethylene oxide having, based on rheological measurements, an approximate molecular weight of 4,000,000;(ii) 40 mg of said oxycodone or pharmaceutically acceptable salt and at least 72% by weight, based upon the total weight of said composition, of said at least one polyethylene oxide having, based on rheological measurements, an approximate molecular weight of 4,000,000;(iii) 60 mg of said oxycodone or pharmaceutically acceptable salt and at least 57% by weight, based upon the total weight of said composition, of said at least one polyethylene oxide having, based on rheological measurements, an approximate molecular weight of 4,000,000; or(iv) 80 mg of said oxycodone or pharmaceutically acceptable salt and at least 54% by weight, based upon the total weight of said composition, of said at least one polyethylene oxide having, based on rheological measurements, an approximate molecular weight of 4,000,000.
地址 Stamford CT US