公开(公告)号：US06899896B2

公开(公告)日：2005-05-31

申请号：US09745096

申请日：2000-12-20

申请人： William J. Curatolo ,  Kenneth C. Waterman ,  Avinash G. Thombre ,  Michael B. Fergione ,  Michael C. Roy ,  Leah A. Appel ,  Danni Supplee ,  Dwayne T. Friesen ,  Mark B. Chidlaw ,  Ronald A. Beyerinck

发明人： William J. Curatolo ,  Kenneth C. Waterman ,  Avinash G. Thombre ,  Michael B. Fergione ,  Michael C. Roy ,  Leah A. Appel ,  Danni Supplee ,  Dwayne T. Friesen ,  Mark B. Chidlaw ,  Ronald A. Beyerinck

IPC分类号： A61K9/26 ,  A61K9/00 ,  A61K9/22 ,  A61K9/36 ,  A61K31/135 ,  A61K47/10 ,  A61K47/12 ,  A61K47/26 ,  A61K47/32 ,  A61K47/34 ,  A61K47/36 ,  A61K47/38 ,  A61P3/04 ,  A61P15/00 ,  A61P15/10 ,  A61P25/20 ,  A61P25/22 ,  A61P25/24 ,  A61P25/30 ,  A61P43/00 ,  A61K9/24 ,  A61K9/32

CPC分类号： A61K9/0004 ,  A61K31/135 ,  Y10S514/951

摘要： A controlled release dosage form for sertraline has a core comprising a sertraline-containing composition and a water-swellable composition wherein the water-swellable composition is in a separate region within the core. A coating around the core is water-permeable, water-insoluble, and has at least one delivery port therethrough. In one embodiment, the dosage form releases sertraline to the use environment at an average rate of 6 to 10 wt % per hour from the second to the twenth hour after introduction to a use environment and less than about 25 wt % for the first two hours and at least 70 wt % by the twelfth hour, where the percentages correspond to the mass of drug released from the tablet divided by the total mass of drug originally present in the tablet. In another embodiment, the dosage form releases less than about 25 wt % of sertraline to the use environment by the second hour after introduction of the dosage form to the use environment, and delivers at least 25 wt % from the eighth to the twenty-fourth hour.

摘要翻译： 舍曲林的控制释放剂型具有包含含舍曲林组合物和水溶胀性组合物的核心，其中水溶胀性组合物在核心内的分离区域中。 芯周围的涂层是透水的，不溶于水的，并且具有至少一个通过其的输送口。 在一个实施方案中，剂型在引入使用环境后的第二至第十小时以平均速率以每小时6至10重量％的平均速率释放到使用环境，并且在前两小时内小于约25重量％ 和至少70重量％，其中百分比对应于从片剂释放的药物的质量除以最初存在于片剂中的药物的总质量。 在另一个实施方案中，在将剂型引入使用环境后第二小时，剂型释放小于约25重量％的舍曲林至使用环境，并且从第八至第二十四至第十二 小时。

公开(公告)号：US07790197B2

公开(公告)日：2010-09-07

申请号：US10828079

申请日：2004-04-20

申请人： Michael B. Fergione ,  Barbara A. Johnson ,  Kenneth Craig Waterman

发明人： Michael B. Fergione ,  Barbara A. Johnson ,  Kenneth Craig Waterman

IPC分类号： A61K9/26

CPC分类号： A61K9/1623 ,  A61K9/1652 ,  A61K31/40

摘要： A wet granulated pharmaceutical composition comprising atorvastatin or a pharmaceutically acceptable salt thereof with less than about 5 weight % of an alkaline earth metal salt additive with a disintegrant which provides the atorvastatin with not more than about 3% atorvastatin lactone based on the ratio of lactone peak area compared to the total drug-related peak integrated areas, as well as said wet granulated pharmaceutical composition comprising atorvastatin or a pharmaceutically acceptable salt thereof in combination with at least one other active drug, methods for preparing said compositions, kits for containing such compositions, and a method of treating hypercholesterolemia and/or hyperlipidemia, osteoporosis, benign prostatic hyperplasia (BPH), and Alzheimer's disease using a therapeutically effective amount of the pharmaceutical compositions.

摘要翻译： 一种湿颗粒状药物组合物，其包含阿托伐他汀或其药学上可接受的盐和小于约5重量％的具有崩解剂的碱土金属盐添加剂，其基于内酯峰的比例提供阿托伐他汀不超过约3％的阿托伐他汀内酯 以及所述含有阿托伐他汀或其药学上可接受的盐与至少一种其它活性药物组合的湿法制粒药物组合物，所述组合物的制备方法，用于含有该组合物的试剂盒， 以及使用治疗有效量的药物组合物治疗高胆固醇血症和/或高脂血症，骨质疏松症，良性前列腺增生症（BPH）和阿尔茨海默病的方法。