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1. 发明申请

WO2009114606A1 DRUG DELIVERY SYSTEMS COMPRISING WEAKLY BASIC DRUGS AND ORGANIC ACIDS 审中-公开
标题翻译：包含弱碱性药物和有机酸的药物输送系统
公开(公告)号：WO2009114606A1
公开(公告)日：2009-09-17
申请号：PCT/US2009/036787
申请日：2009-03-11
申请人： EURAND INC , VENKATESH, Gopi , LAI, Jin-Wang , VYAS, Nehal, H. , PUROHIT, Vivek
发明人： VENKATESH, Gopi , LAI, Jin-Wang , VYAS, Nehal, H. , PUROHIT, Vivek
IPC分类号： A61K9/30
CPC分类号： A61K31/4178 , A61K9/1617 , A61K9/1623 , A61K9/1635 , A61K9/1652 , A61K9/1676 , A61K9/2081 , A61K9/48 , A61K9/5042 , A61K9/5078 , A61K9/5084
摘要： The present invention is directed to pharmaceutical compositions, and methods of making such compositions, wherein the compositions comprise a plurality of TPR and RR particles, wherein: the TPR particles each comprise a core coated with a TPR layer; the core comprises a weakly basic, poorly soluble drug and a pharmaceutically acceptable organic acid separated from each other by an SR layer; the RR particles each comprise the weakly basic, poorly soluble drug, and release at least about 80 wt.% of the weakly basic, poorly soluble drug in about 5 minutes when dissolution tested using United States Pharmacopoeia (USP) dissolution methodology (Apparatus 2 - paddles@ 50 RPM and a two-stage dissolution medium at 37°C (first 2 hours in 0.1N HCl followed by testing in a buffer at pH 6.8).
摘要翻译：本发明涉及药物组合物和制备这种组合物的方法，其中组合物包含多个TPR和RR颗粒，其中：TPR颗粒各自包含涂覆有TPR层的芯; 核心包括通过SR层彼此分离的弱碱性，难溶性药物和药学上可接受的有机酸; RR颗粒各自包含弱碱性，难溶性药物，并且在使用美国药典（USP）溶出方法进行溶出测试时，在约5分钟内释放至少约80重量％的弱碱性，难溶性药物（装置2- 桨叶（50RPM）和两步溶解培养基（37℃）（在0.1N HCl中开始2小时，然后在pH6.8的缓冲液中测试）。

2. 发明申请

WO2007090082A2 DRUG DELIVERY SYSTEMS COMPRISING WEAKLY BASIC SELECTIVE SEROTONIN 5-HT3 BLOCKING AGENT AND ORGANIC ACIDS 审中-公开
标题翻译：包含弱碱性选择性丝氨酸5-HT3阻断剂和有机酸的药物递送系统
公开(公告)号：WO2007090082A2
公开(公告)日：2007-08-09
申请号：PCT/US2007/061217
申请日：2007-01-29
申请人： EURAND, INC. , VENKATESH, Gopi, M. , LAI, Jin-wang , VYAS, Nehal, H.
发明人： VENKATESH, Gopi, M. , LAI, Jin-wang , VYAS, Nehal, H.
CPC分类号： A61K9/2077 , A61K9/0056 , A61K9/5073 , A61K9/5084 , A61K31/4178
摘要： A pharmaceutical dosage form such as a capsule, a conventional or orally disintegrating tablet capable of delivering a weakly basic, nitrogen (N)-containing selective serotonin 5- HT 3 blocking agent having a pKa in the range of from about 5 to 14 and a solubility of not more than about 200 µg/mL at pH 6.8 into the body in a sustained-released fashion, suitable for a once-daily dosing regimen, comprises at least one organic acid, which solubilizes said weakly basic selective serotonin 5-HT3 blocking agent prior to releasing it into the hostile intestinal environment wherein the blocking agent is practically insoluble. The unit dosage form may be composed of a multitude of multicoated particulates (i.e., immediate-release beads, sustained-release beads and/or one or more timed, pulsatile- release bead populations) and is designed in such a way that the weakly basic blocking agent and the organic acid do not come into close contact during processing and/or storage thereby avoiding in-situ formation of acid addition compounds while ensuring that the acid is not depleted prior to completion of the drug release.
摘要翻译：一种药物剂型，例如胶囊，常规或口腔崩解片，其能够递送具有pKa范围的弱碱性，含氮（N）的选择性5-羟色胺5-羟色胺阻断剂约5至14，并且以pH 6.8的不超过约200μg/ mL的溶解度以持续释放的方式适应于每日一次的给药方案，包含至少一种有机酸，其溶解所述弱化碱性选择性5-羟色胺5-HT 3封闭剂在将其释放到敌对肠道环境中之前，其中封闭剂几乎不溶解。单位剂量形式可以由多种多重微粒（即即释丸，缓释珠和/或一个或多个定时，脉冲释放珠群）组成，并且以这样的方式设计：弱碱性封闭剂和有机酸在加工和/或储存期间不会紧密接触，从而避免了原位形成酸加成化合物，同时确保在药物释放完成之前酸不被耗尽。

3. 发明申请

WO2007090082A3 DRUG DELIVERY SYSTEMS COMPRISING WEAKLY BASIC SELECTIVE SEROTONIN 5-HT3 BLOCKING AGENT AND ORGANIC ACIDS 审中-公开
标题翻译：包含弱碱性选择性丝氨酸5-HT3阻断剂和有机酸的药物递送系统
公开(公告)号：WO2007090082A3
公开(公告)日：2007-12-21
申请号：PCT/US2007061217
申请日：2007-01-29
申请人： EURAND INC , VENKATESH GOPI M , LAI JIN-WANG , VYAS NEHAL H
发明人： VENKATESH GOPI M , LAI JIN-WANG , VYAS NEHAL H
IPC分类号： A61K9/22
CPC分类号： A61K9/2077 , A61K9/0056 , A61K9/5073 , A61K9/5084 , A61K31/4178
摘要： A pharmaceutical dosage form such as a capsule, a conventional or orally disintegrating tablet capable of delivering a weakly basic, nitrogen (N)-containing selective serotonin 5- HT 3 blocking agent having a pKa in the range of from about 5 to 14 and a solubility of not more than about 200 µg/mL at pH 6.8 into the body in a sustained-released fashion, suitable for a once-daily dosing regimen, comprises at least one organic acid, which solubilizes said weakly basic selective serotonin 5-HT 3 blocking agent prior to releasing it into the hostile intestinal environment wherein the blocking agent is practically insoluble. The unit dosage form may be composed of a multitude of multicoated particulates (i.e., immediate-release beads, sustained-release beads and/or one or more timed, pulsatile- release bead populations) and is designed in such a way that the weakly basic blocking agent and the organic acid do not come into close contact during processing and/or storage thereby avoiding in-situ formation of acid addition compounds while ensuring that the acid is not depleted prior to completion of the drug release.
摘要翻译：一种药物剂型，例如胶囊，常规或口腔崩解片，其能够递送具有pKa范围的弱碱性，含氮（N）的选择性5-羟色胺5-羟色胺阻断剂约5至14，并且以pH 6.8的不超过约200μg/ mL的溶解度以持续释放的方式适应于每日一次的给药方案，包含至少一种有机酸，其溶解所述弱化碱性选择性5-羟色胺5-HT 3封闭剂，然后将其释放到敌对的肠道环境中，其中封闭剂几乎不溶。单位剂量形式可以由多种多重微粒（即即释丸，缓释珠和/或一个或多个定时，脉冲释放珠群）组成，并且以这样的方式设计：弱碱性封闭剂和有机酸在加工和/或储存期间不会紧密接触，从而避免了原位形成酸加成化合物，同时确保在药物释放完成之前酸不被耗尽。

4. 发明申请

WO2005004919A8 EXTENDED RELEASE SYSTEMS FOR MACROLIDE ANTIBIOTICS 审中-公开
标题翻译：用于大量抗生素的扩展释放系统
公开(公告)号：WO2005004919A8
公开(公告)日：2005-08-04
申请号：PCT/US2004020620
申请日：2004-06-28
申请人： EURAND INC , VENKATESH GOPI M , VYAS NEHAL H , QIAN KEN KANGYI
发明人： VENKATESH GOPI M , VYAS NEHAL H , QIAN KEN KANGYI
IPC分类号： A61K9/20 , A61K31/7048 , A61K47/22
CPC分类号： A61K31/7048 , A61K9/2018 , A61K9/2027
摘要： A unit dosage form, such as a tablet or the like for delivering poorly water soluble macrolide antibiotics such as Clarithromycin into the body in an extended release fashion, is designed to release the active ingredient primarily by tablet erosion though the tablet composition does not comprise any dissolution rate controlling agent, a polymer or esters of fatty acids. Such a drug delivery system provides a plasma concentration - time profile suitable for once a day oral administration.
摘要翻译：设计用于将不良水溶性大环内酯类抗生素如克拉霉素以延长释放方式递送到体内的单位剂量形式，例如片剂等，主要通过片剂侵蚀释放活性成分，但片剂组合物不包含任何溶解速率控制剂，脂肪酸的聚合物或酯。这种药物递送系统提供适合于每天一次口服给药的血浆浓度 - 时间特征。

5. 发明申请

WO2009006516A1 ORALLY DISINTEGRATING TABLET COMPOSITIONS OF LAMOTRIGINE 审中-公开
标题翻译：洛伐他汀的片剂组合物的ORALLY DISINCAGE
公开(公告)号：WO2009006516A1
公开(公告)日：2009-01-08
申请号：PCT/US2008/069000
申请日：2008-07-02
申请人： EURAND, INC. , VENKATESH, Gopi M. , VYAS, Nehal H. , GOSSELIN, Michael , LAI, Jin-wang
发明人： VENKATESH, Gopi M. , VYAS, Nehal H. , GOSSELIN, Michael , LAI, Jin-wang
IPC分类号： A01N43/64 , A61K31/53
CPC分类号： A61K31/53 , A61K9/0007 , A61K9/0056 , A61K9/2072 , A61K9/2077 , A61K9/2081 , A61K9/2095 , A61K9/5005 , A61K9/5015 , A61K9/5026 , A61K9/5031 , A61K9/5042 , A61K9/5047 , A61K9/5084 , A61K9/5089
摘要： The compositions of the present invention composition comprise a therapeutically effective amount of particles comprising lamotrigine, in combination with granules comprising a disintegrant, and a sugar alcohol and/or a saccharide. These compositions are useful in treating epilepsy and bipolar disorder, particularly for patients with dysphagia, and to improve compliance with bipolar patients.
摘要翻译：本发明组合物的组合物包含治疗有效量的包含拉莫三嗪的颗粒，以及包含崩解剂和糖醇和/或糖类的颗粒。这些组合物可用于治疗癫痫和双相障碍，特别是对于吞咽困难的患者，并改善对双相患者的依从性。

6. 发明申请

WO2005004919A3 EXTENDED RELEASE SYSTEMS FOR MACROLIDE ANTIBIOTICS 审中-公开
标题翻译： MACROLIDE抗生素的扩展释放系统
公开(公告)号：WO2005004919A3
公开(公告)日：2005-03-17
申请号：PCT/US2004020620
申请日：2004-06-28
申请人： EURAND INC , VENKATESH GOPI M , VYAS NEHAL H , QIAN KEN KANGYI
发明人： VENKATESH GOPI M , VYAS NEHAL H , QIAN KEN KANGYI
IPC分类号： A61K9/20 , A61K31/7048 , A61K47/22
CPC分类号： A61K31/7048 , A61K9/2018 , A61K9/2027
摘要： A unit dosage form, such as a tablet or the like for delivering poorly water soluble macrolide antibiotics such as Clarithromycin into the body in an extended release fashion, is designed to release the active ingredient primarily by tablet erosion though the tablet composition does not comprise any dissolution rate controlling agent, a polymer or esters of fatty acids. Such as drug delivery system provides a plasma concentration - time profile suitable for once a day oral transmission.
摘要翻译：用于以缓释方式将难溶于水的大环内酯类抗生素如克拉霉素递送到体内的单位剂型如片剂等被设计为主要通过片剂侵蚀释放活性成分，尽管片剂组合物不包含任何溶解速率控制剂，一种或多种脂肪酸酯。如药物输送系统提供的血浆浓度 - 时间曲线适合每天口服一次。

7. 发明申请

WO2005004919A2 EXTENDED RELEASE SYSTEMS FOR MACROLIDE ANTIBIOTICS 审中-公开
标题翻译：用于大量抗生素的扩展释放系统
公开(公告)号：WO2005004919A2
公开(公告)日：2005-01-20
申请号：PCT/US2004/020620
申请日：2004-06-28
申请人： EURAND, INC. , VENKATESH, Gopi, M. , VYAS, Nehal, H. , QIAN, Ken, Kangyi
发明人： VENKATESH, Gopi, M. , VYAS, Nehal, H. , QIAN, Ken, Kangyi
IPC分类号： A61K47/22
CPC分类号： A61K31/7048 , A61K9/2018 , A61K9/2027
摘要： A unit dosage form, such as a tablet or the like for delivering poorly water soluble macrolide antibiotics such as Clarithromycin into the body in an extended release fashion, is designed to release the active ingredient primarily by tablet erosion though the tablet composition does not comprise any dissolution rate controlling agent, a polymer or esters of fatty acids. Such as drug delivery system provides a plasma concentration - time profile suitable for once a day oral transmission.
摘要翻译：设计用于将不良水溶性大环内酯类抗生素如克拉霉素以延长释放方式递送到体内的单位剂量形式，例如片剂等，主要通过片剂侵蚀释放活性成分，但片剂组合物不包含任何溶解速率控制剂，脂肪酸的聚合物或酯。如药物递送系统提供适合每天一次口服传播的血浆浓度 - 时间特征。

8. 发明申请

WO2003051343A1 PULSATILE RELEASE HISTAMINE H2 ANTAGONIST DOSAGE FORMS 审中-公开
标题翻译： PULSATILE RELEASE HISTAMINE H2 ANTAGONIST剂型
公开(公告)号：WO2003051343A1
公开(公告)日：2003-06-26
申请号：PCT/US2002/039238
申请日：2002-12-09
申请人： EURAND PHARMACEUTICALS LTD. , PERCEL, Philip, J. , VENKATESH, Gopi, M. , VISHNUPAD, Krishna, S. , VYAS, Nehal, H.
发明人： PERCEL, Philip, J. , VENKATESH, Gopi, M. , VISHNUPAD, Krishna, S. , VYAS, Nehal, H.
IPC分类号： A61K9/50
CPC分类号： A61K9/5084 , A61K9/5026 , A61K9/5042 , A61K9/5047 , A61K9/5078 , Y10S514/965
摘要： A unit dosage form, such as a capsule or the like, for delivering drugs into the body in a circadian release fashion comprising one or more populations of drug-containing particles (beads, pellets, granules, etc.) is disclosed. Each bead population exhibits a pre-designed rapid or sustained release profile with or without a predetermined lag time of 3 to 5 hours. Such a circadian rhythm release drug delivery system is designed to provide a plasma concentration - time profile, which varies according to physiological need at different times during the dosing period, i.e., mimicking the circadian rhythm and severity/manifestation of gastric acid secretion (and/or midnight gerd), predicted based on pharmaco-kinetic and pharmaco-dynamic considerations and in vitro/in vivo correlations.
摘要翻译：公开了一种用于以包含一种或多种含药颗粒（珠粒，丸粒，颗粒等）群体的昼夜释放方式将药物输送到体内的单位剂型，例如胶囊等。每个珠粒表现出具有或不具有3至5小时的预定滞后时间的预设计的快速或持续释放曲线。这种昼夜节律释放药物递送系统被设计成提供血浆浓度 - 时间分布，其在给药期间的不同时间根据生理需要而变化，即模拟昼夜节律和胃酸分泌的严重性/表现（和/ 或午夜g d），基于药物动力学和药物动力学考虑以及体外/体内相关性预测。

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