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    • 1. 发明授权
    • Stabilized sustained release tramadol formulations
    • 稳定缓释曲马多配方
    • US06306438B1
    • 2001-10-23
    • US09109615
    • 1998-07-02
    • Benjamin OshlackHua-Pin HuangMark ChasinPaul Goldenheim
    • Benjamin OshlackHua-Pin HuangMark ChasinPaul Goldenheim
    • A61K922
    • A61K9/2054A61K9/2013A61K9/2095
    • A stabilized sustained release oral solid dosage form which includes an effective amount of tramadol or a pharmaceutically acceptable salt thereof dispersed in a matrix of a hydrophobic material comprising a wax-like substance which was melted or softened during the preparation of the matrix, is cured at a temperature from about 35° C. to about 65° C. for a time period from about 4 to about 72 hours, such that the formulation, when subjected to in-vitro dissolution after exposure to accelerated storage conditions of at least one month at 40° C./75% RH, releases an amount of tramadol which does not vary at any given dissolution time point by more than about 20% of the total amount of tramadol released when compared to in-vitro dissolution conducted prior to subjecting the dosage form to the accelerated storage conditions.
    • 稳定的持续释放口服固体剂型,其包含分散在疏水性材料的基质中的有效量的曲马朵或其药学上可接受的盐,其包含在制备基质期间熔融或软化的蜡状物质,其在 温度为约35℃至约65℃,时间为约4至约72小时,使得当暴露于至少一个月的加速储存条件后经受体外溶解时,该制剂 40℃/ 75%RH时,释放一定量的曲马多,与任何给定的溶解时间点相比,在与给药剂量之前进行的体外溶出相比,释放曲马多总量的大约20% 形成加速存储条件。