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1. 发明授权

US06528090B2 Controlled release formulation of divalproex sodium 有权
公开(公告)号：US06528090B2
公开(公告)日：2003-03-04
申请号：US09748566
申请日：2000-12-22
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： A61K31/19 , A61K9/2009 , A61K9/2018 , A61K9/2054
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.

2. 发明授权

US06511678B2 Controlled release formulation of divalproex sodium 有权
公开(公告)号：US06511678B2
公开(公告)日：2003-01-28
申请号：US09748567
申请日：2000-12-22
申请人： Yihong Qiu , J. Daniel Bollinger , Sandeep Dutta , Howard S. Cheskin , Kevin R. Engh , Richard P. Poska
发明人： Yihong Qiu , J. Daniel Bollinger , Sandeep Dutta , Howard S. Cheskin , Kevin R. Engh , Richard P. Poska
IPC分类号： A61K900
CPC分类号： A61K31/191 , A61K9/2009 , A61K9/2018 , A61K9/2054 , 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.

3. 发明授权

US06720004B2 Controlled release formulation of divalproex sodium 有权
公开(公告)号：US06720004B2
公开(公告)日：2004-04-13
申请号：US10215141
申请日：2002-08-08
申请人： Yihong Qiu , J. Daniel Bollinger , Sandeep Dutta , Howard S. Cheskin , Kevin R. Engh , Richard P. Poska
发明人： Yihong Qiu , J. Daniel Bollinger , Sandeep Dutta , Howard S. Cheskin , Kevin R. Engh , Richard P. Poska
IPC分类号： A61K900
CPC分类号： A61K31/191 , A61K9/2009 , A61K9/2018 , A61K9/2054 , 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.

4. 发明授权

US06713086B2 Controlled release formulation of divalproex sodium 有权
标题翻译：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。

5. 发明授权

US06419953B1 Controlled release formulation of divalproex sodium 有权
标题翻译：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。

6. 发明授权

US06528091B1 Controlled release formulation of divalproex sodium 有权
标题翻译：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。

7. 发明授权

US06180138B2 Process for preparing solid formulations of lipid-regulating agents with enhanced dissolution and absorption 有权
标题翻译：用于制备具有增强的溶解和吸收的脂质调节剂的固体制剂的方法
公开(公告)号：US06180138B2
公开(公告)日：2001-01-30
申请号：US09239889
申请日：1999-01-29
申请人： Kevin R. Engh , Yihong Qiu , Thomas L. Reiland
发明人： Kevin R. Engh , Yihong Qiu , Thomas L. Reiland
IPC分类号： A61K920
CPC分类号： A61K9/1617 , A61K9/1611 , A61K9/1623
摘要： A process for the preparation of solid formulations of a lipid-regulating agent having enhanced dissolution and absorption characteristics, in which a micronized mixture of the said lipid-regulating agent, and optionally one or more excipients, is suspended in a surfactant solution, dried and optionally granulated, and optionally converted to a finished dosage form.
摘要翻译：制备具有增强的溶解和吸收特性的脂质调节剂的固体制剂的方法，其中所述脂调节剂的微粉化混合物和任选的一种或多种赋形剂悬浮在表面活性剂溶液中，干燥和任选地造粒，并任选地转化成最终的剂型。

8. 发明授权

US06383517B1 Process for preparing solid formulations of lipid-regulating agents with enhanced dissolution and absorption 有权
标题翻译：用于制备具有增强的溶解和吸收的脂质调节剂的固体制剂的方法
公开(公告)号：US06383517B1
公开(公告)日：2002-05-07
申请号：US09240516
申请日：1999-01-29
申请人： Yihong Qiu , Venkatramana M. Rao , Kevin R. Engh , Thomas L. Reiland
发明人： Yihong Qiu , Venkatramana M. Rao , Kevin R. Engh , Thomas L. Reiland
IPC分类号： A61K920
CPC分类号： A61K9/1617 , A61K9/1623 , A61K9/1635 , A61K9/1652
摘要： A process for preparing a solid formulation of a lipid-regulating agent comprising dissolving said lipid-regulating agent particles in a surfactant solution, premixing an excipient, wet granulating the mixture, drying the mixture and forming a finished dosage form.
摘要翻译：一种制备脂调节剂的固体制剂的方法，包括将所述脂调节剂颗粒溶解在表面活性剂溶液中，预先混合赋形剂，将混合物湿法制粒，干燥混合物并形成成品剂型。

9. 发明授权

US06368622B2 Process for preparing solid formulations of lipid regulating agents with enhanced dissolution and absorption 有权
标题翻译：用于制备具有增强的溶解和吸收的脂质调节剂的固体制剂的方法
公开(公告)号：US06368622B2
公开(公告)日：2002-04-09
申请号：US09240515
申请日：1999-01-29
申请人： Yisheng Chen , Kevin R. Engh , Yihong Qiu , Thomas L. Reiland
发明人： Yisheng Chen , Kevin R. Engh , Yihong Qiu , Thomas L. Reiland
IPC分类号： A61K920
CPC分类号： A61K31/216 , A61K9/1694 , A61K9/4866
摘要： A process for preparing a solid formulation of a lipid-regulating agent comprising forming a mixture of said lipid-regulating agent with a surfactant; granulating said mixture by melting, mixing, and congealing said mixture; and optionally forming a finished dosage form.
摘要翻译：一种制备脂调节剂的固体制剂的方法，包括形成所述脂调节剂与表面活性剂的混合物; 通过熔融，混合和凝结所述混合物对所述混合物进行造粒; 并任选地形成成品剂型。

10. 发明授权

US6150410A pH independent extended release pharmaceutical formulation 有权
标题翻译： pH独立延长释放药物制剂
公开(公告)号：US6150410A
公开(公告)日：2000-11-21
申请号：US490531
申请日：2000-01-25
申请人： Kevin R. Engh , Yihong Qiu , Venkatramana M. Rao
发明人： Kevin R. Engh , Yihong Qiu , Venkatramana M. Rao
IPC分类号： A61K9/20 , A61K31/19 , A61K47/00 , A61K47/30
CPC分类号： A61K31/19 , A61K9/2018 , A61K9/2027 , A61K9/2054
摘要： Pharmaceutical formulations of acidic pharmacologic agents which demonstrate improved uniformity of release over the wide range of pH values encountered between the stomach and intestinal tract comprise an acidic pharmacologic agent dissolved or dispersed in a matrix comprising about 10 weight percent to about 40 weight percent of a a neutral water-swellable hydrophilic polymer and 20 weight percent to about 50 weight percent of an acid-soluble polymer which swells in water at pH values above about 5. A particularly preferred formulation comprises divalproex sodium. Also disclosed are pre-tablet granulations and process for preparing both the pre-tablet granulation and the tablet unit dosage form.
摘要翻译：在胃和肠道之间在宽范围的pH范围内显示出改善的释放均匀性的酸性药物制剂的药物制剂包含溶解或分散在基质中的酸性药理剂，其包含约10重量％至约40重量％的中性水溶胀性亲水性聚合物和20重量％至约50重量％的在pH值高于约5的水中溶胀的酸溶性聚合物。特别优选的制剂包含双丙戊酸钠。还公开了片剂前颗粒和制备片剂前制剂和片剂单位剂型的方法。

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