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    Controlled release formulation of divalproex sodium
    4.
    发明授权
    Controlled release formulation of divalproex sodium 有权
    双丙戊酸钠的控释制剂

    公开(公告)号：US06713086B2

    公开(公告)日：2004-03-30

    申请号：US10215142

    申请日：2002-08-08

    申请人： Yihong Qiu ,  J. Daniel Bollinger ,  Howard S. Cheskin ,  Sandeep Dutta ,  Kevin R. Engh ,  Richard P. Poska

    发明人： Yihong Qiu ,  J. Daniel Bollinger ,  Howard S. Cheskin ,  Sandeep Dutta ,  Kevin R. Engh ,  Richard P. Poska

    IPC分类号： A61K900

    CPC分类号： A61K9/2054 ,  A61K9/2009 ,  A61K9/2018 ,  A61K31/19

    摘要： A new oral polymeric controlled release formulation suitable for the once-a-day administration of valproate compounds, such as divalproex sodium, has been discovered. This formulation exhibits significant advantages over the sustained release valproate formulations of the prior art. This formulation minimizes the variation between peak and trough plasma levels of valproate over a 24 hour dosing period. This formulation follows a zero-order release pattern thus producing essentially flat plasma levels of valproate, once steady-state levels have been achieved. This results in a significantly lower incidence of side effects for patients consuming such a formulation.

    摘要翻译： 已经发现了适用于每日一次施用丙戊酸酯化合物如新戊酸钠的新的口服聚合物控释制剂。 该配方表现出优于现有技术的缓释丙戊酸酯制剂的显着优点。 该制剂使24小时给药期间丙戊酸钠和谷氨酸血浆水平之间的变化最小化。 一旦达到稳态水平，该配方就遵循零级释放模式，从而产生基本平坦的丙戊酸血浆水平。 这导致消耗这种制剂的患者的副作用发生率显着降低。

    Controlled release formulation of divalproex sodium
    5.
    发明授权
    Controlled release formulation of divalproex sodium 有权
    双丙戊酸钠的控释制剂

    公开(公告)号：US06419953B1

    公开(公告)日：2002-07-16

    申请号：US09216650

    申请日：1998-12-18

    申请人： Yihong Qiu ,  Paul Richard Poska ,  Howard S. Cheskin ,  J. Daniel Bollinger ,  Robert K. Engh

    发明人： Yihong Qiu ,  Paul Richard Poska ,  Howard S. Cheskin ,  J. Daniel Bollinger ,  Robert K. Engh

    IPC分类号： A61K920

    CPC分类号： A61K9/2054 ,  A61K9/2009 ,  A61K9/2018 ,  A61K31/19

    摘要： The present invention pertains to a hydrophilic matrix tablet suitable for the once-a-day administration of valproate compounds such as divalproex sodium. The tablet comprises from about 50 weight percent to about 55 weight percent of an active ingredient selected from the group consisting of valproic acid, a pharmaceutically acceptable salt or ester of valproic acid, divalproex sodium, and valpromide; from about 20 weight percent to about 40 weight percent hydroxypropyl methylcellulose; from about 5 weight percent to about 15 weight percent lactose, from about 4 weight percent to about 6 weight percent microcrystalline cellulose, and from about 1 weight percent to about 5 weight percent of silicon dioxide; all weight percentages based upon the total weight of the tablet dosage form. Other aspects of the invention relate to the use of this formulation in the treatment of epilepsy and to methods for manufacturing this dosage form.

    摘要翻译： 本发明涉及一种适用于丙戊酸酯化合物例如双丙戊酸钠一天一次给药的亲水性基质片剂。 片剂包含约50重量％至约55重量％的选自丙戊酸，丙戊酸的药学上可接受的盐或酯，双丙戊酸钠和伏立康胺的活性成分; 约20重量％至约40重量％的羟丙基甲基纤维素; 约5重量％至约15重量％的乳糖，约4重量％至约6重量％的微晶纤维素和约1重量％至约5重量％的二氧化硅; 所有重量百分比均基于片剂剂型的总重量。 本发明的其它方面涉及该制剂在治疗癫痫中的用途以及制备该剂型的方法。

    Controlled release formulation of divalproex sodium
    6.
    发明授权
    Controlled release formulation of divalproex sodium 有权
    双丙戊酸钠的控释制剂

    公开(公告)号：US06528091B1

    公开(公告)日：2003-03-04

    申请号：US10143559

    申请日：2002-05-10

    申请人： Yihong Qiu ,  Paul Richard Poska ,  Howard S. Cheskin ,  J. Daniel Bollinger ,  Robert K. Engh

    发明人： Yihong Qiu ,  Paul Richard Poska ,  Howard S. Cheskin ,  J. Daniel Bollinger ,  Robert K. Engh

    IPC分类号： A61K920

    CPC分类号： A61K9/2054 ,  A61K9/2009 ,  A61K9/2018 ,  A61K31/19

    摘要： A controlled release tablet formulation which permits once daily dosing in the treatment of epilepsy comprises from about 50 weight percent to about 55 weight percent of an active ingredient selected from the group consisting of valproic acid, a pharmaceutically acceptable salt or ester of valproic acid, divalproex sodium, and valpromide; from about 20 weight percent to about 40 weight percent hydroxypropyl methylcellulose; from about 5 weight percent to about 15 weight percent lactose, from about 4 weight percent to about 6 weight percent microcrystalline cellulose, and from about 1 weight percent to about 5 weight percent silicon dioxide having an average particle size ranging between about 1 micron and about 10 microns; all weight percentages based upon the total weight of the tablet dosage form. Also disclosed are pre-tableting granular formulations, methods of making the granular formulations and tablets, and a method of treating epilepsy employing the controlled release tablet formulations of the invention.

    摘要翻译： 允许每日一次给药治疗癫痫的控释片剂制剂包含约50重量％至约55重量％的活性成分，选自丙戊酸，丙戊酸的药学上可接受的盐或酯，双丙戊酸 钠和valpromide; 约20重量％至约40重量％的羟丙基甲基纤维素; 约5重量％至约15重量％的乳糖，约4重量％至约6重量％的微晶纤维素和约1重量％至约5重量％的二氧化硅，平均粒度范围介于约1微米至约 10微米; 所有重量百分比均基于片剂剂型的总重量。 还公开了预压片颗粒制剂，制备颗粒制剂和片剂的方法，以及使用本发明的控释片剂制剂治疗癫痫的方法。