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1. 发明授权

US08545881B2 Orally disintegrating tablets and methods of manufacture 有权
公开(公告)号：US08545881B2
公开(公告)日：2013-10-01
申请号：US10827106
申请日：2004-04-19
申请人： Gopi M. Venkatesh , Ken Kangyi Qian , Shyam Vangala , James M. Clevenger , Donald Guenther
发明人： Gopi M. Venkatesh , Ken Kangyi Qian , Shyam Vangala , James M. Clevenger , Donald Guenther
IPC分类号： A61K9/20 , A61K9/50
CPC分类号： A61K9/2081 , A61K9/0056 , A61K9/1623 , A61K9/1635 , A61K9/2018 , A61K9/2027 , A61K9/2095 , A61K9/5042 , A61K31/34 , A61K31/341 , A61K31/4045
摘要： A tablet that rapidly disintegrates in the oral cavity comprising a compressed blend of rapidly dispersing microgranules prepared by granulating a sugar alcohol or a saccharide or a mixture thereof having an average particle size less than about 30 microns and a disintegrant, and a taste-masked microcapsule containing at least one drug, the microcapsule being prepared by granulating a pharmaceutically acceptable formulation comprising at least one drug in a therapeutically effective amount and at least one polymeric binder that improves resilience of the microgranules, wet milling the granulated mass, and microencapsulating the milled granules to provide microcapsules.

2. 发明申请

US20090263480A1 TASTE-MASKED PHARMACEUTICAL COMPOSITIONS PREPARED BY COACERVATION 审中-公开
标题翻译：通过加工制备的烟草制品药物组合物
公开(公告)号：US20090263480A1
公开(公告)日：2009-10-22
申请号：US12466855
申请日：2009-05-15
申请人： Jin-Wang Lai , Ken Kangyi Qian , Gopi M. Venkatesh
发明人： Jin-Wang Lai , Ken Kangyi Qian , Gopi M. Venkatesh
IPC分类号： A61K9/20 , A61P43/00
CPC分类号： A61K9/0056 , A61K9/1676 , A61K9/2077 , A61K31/4045 , A61K31/495
摘要： There is provided a method for preparing an orally disintegrating tablet (ODT) composition comprising microparticles of one or more taste-masked active pharmaceutical ingredients, rapidly-dispersing microgranules, and other optional, pharmaceutically acceptable excipients wherein the ODT disintegrates rapidly with saliva in the buccal cavity forming a smooth, easy-to-swallow suspension. Furthermore, the microparticles (crystals, granules, beads or pellets containing one or more actives) with a taste-masking membrane applied by a modified solvent coacervation process comprising a water-insoluble polymer and at least one gastrosoluble inorganic or organic pore-former, exhibit a pleasant taste when placed in the oral cavity and provide rapid, substantially-complete release of the dose on entry into the stomach.
摘要翻译：提供了一种制备包含一种或多种掩味活性药物成分，快速分散微粒和其它任选的药学上可接受的赋形剂的微粒的口腔崩解片（ODT）组合物的方法，其中ODT与颊内的唾液快速分解空腔形成平滑，易于吞咽的悬浮液。此外，通过包含水不溶性聚合物和至少一种胃溶性无机或有机成孔剂的改性溶剂凝聚方法施加的具有掩味膜的微粒（晶体，颗粒，含有一种或多种活性物质的珠粒或丸粒）当放置在口腔中时具有愉悦的味道并且在进入胃中提供快速，基本上完全释放的剂量。

3. 发明申请

US20120282335A1 RAPIDLY DISPERSING GRANULES, ORALLY DISINTEGRATING TABLETS AND METHODS 审中-公开
标题翻译：快速分散颗粒，ORALLY DISPATTING DISPATTING AND METHODS
公开(公告)号：US20120282335A1
公开(公告)日：2012-11-08
申请号：US13310632
申请日：2011-12-02
申请人： Gopi M. Venkatesh , Vijaya Swaminathan , Jin-Wang Lai , James M. Clevenger
发明人： Gopi M. Venkatesh , Vijaya Swaminathan , Jin-Wang Lai , James M. Clevenger
IPC分类号： A61K9/14 , A61K31/445 , A61K31/485 , A61K9/20 , A61K31/167
摘要： This invention relates to rapidly dispersing microgranules comprising at least one sugar alcohol or saccharide, at least one super disintegrant, and a pharmaceutically acceptable additive with multi-functionality (e.g., starch acting as a binder, disintegrant, diluent/filler, glidant, etc) at a low level, which can be formed by not only eliminating a wet milling step but also avoiding an extensive dry milling step. Furthermore, such rapidly dispersing microgranules could also comprise a pharmaceutically active agent thereby providing for a pharmaceutical composition, or the rapidly dispersing microgranules thus produced are suitable for blending with a pharmaceutically active agent that is optionally taste-masked and/or controlled release coated microparticles to also provide for a pharmaceutical composition and the invention is also directed to a method for manufacturing such rapidly dispersing microgranules in a high useable yield, as well as orally disintegrating tablets comprising such rapidly dispersing microgranules. The rapidly dispersing microgranules are also free flowing.
摘要翻译：本发明涉及快速分散包含至少一种糖醇或糖，至少一种超级崩解剂和具有多官能度的药学上可接受的添加剂（例如，作为粘合剂的淀粉，崩解剂，稀释剂/填充剂，助流剂等）的微粒体，在低水平，其可以通过不仅消除湿磨步骤而且可以避免广泛的干磨步骤形成。此外，这种快速分散的微粒还可以包含药物活性剂，从而提供药物组合物，或由此制备的快速分散的微粒适合于与任选地掩蔽和/或控释的微粒的药物活性剂混合，还提供药物组合物，并且本发明还涉及以高可用产率制造这种快速分散的微粒的方法，以及包含这种快速分散的微粒的口腔崩解片。快速分散的微粒也是自由流动的。

4. 发明申请

US20110129530A1 Compressible-Coated Pharmaceutical Compositions and Tablets and Methods of Manufacture 审中-公开
标题翻译：可压缩涂层药物组合物和片剂及其制造方法
公开(公告)号：US20110129530A1
公开(公告)日：2011-06-02
申请号：US12956543
申请日：2010-11-30
申请人： Gopi M. Venkatesh , Jin-Wang Lai , James M. Clevenger , Craig Kramer
发明人： Gopi M. Venkatesh , Jin-Wang Lai , James M. Clevenger , Craig Kramer
IPC分类号： A61K9/26 , A61K9/50 , A61K9/28 , A61K31/485 , A61K31/445 , A61K31/455 , A61K31/341 , A61K31/215 , A61K31/138 , A61P25/00 , A61P29/00 , A61P3/04 , A61P31/00 , A61P3/10 , A61P9/00 , A61P1/00 , A61P25/28 , A61P25/26 , A61P25/18 , A61P25/24
CPC分类号： A61K9/0056 , A61K9/2081 , A61K9/5015 , A61K9/5073 , A61K9/5078 , A61K31/137 , A61K31/167 , A61K31/192 , A61K31/221 , A61K31/341 , A61K31/455 , A61K31/485 , A61K45/06 , A61K2300/00
摘要： There is provided a method for preparing a pharmaceutical composition comprising compressible coated, taste-masked and/or controlled-release coated drug-containing particles, rapidly-dispersing microgranules comprising a disintegrant and a sugar alcohol, a saccharide, or a mixture thereof, and other optional, pharmaceutically acceptable excipients wherein the orally disintegrating tablet (ODT) or rapidly dispersing tablet (RDT) composition having acceptable tableting, organoleptic, and pharmacokinetic properties.
摘要翻译：提供了一种制备药物组合物的方法，所述药物组合物包含可压缩涂覆，掩味和/或控释包衣的含药颗粒，包含崩解剂和糖醇，糖或其混合物的快速分散微粒，以及其它任选的药学上可接受的赋形剂，其中具有可接受的压片，感官和药代动力学性质的口腔崩解片（ODT）或快速分散片剂（RDT）组合物。

5. 发明申请

US20130209567A1 Modified Release Dosage Forms of Skeletal Muscle Relaxants 有权
公开(公告)号：US20130209567A1
公开(公告)日：2013-08-15
申请号：US13570670
申请日：2012-08-09
申请人： Gopi M. Venkatesh , James M. Clevenger
发明人： Gopi M. Venkatesh , James M. Clevenger
IPC分类号： A61K31/137
CPC分类号： A61K31/135 , A61K9/0053 , A61K9/1652 , A61K9/2054 , A61K9/4808 , A61K9/4866 , A61K9/5078 , A61K31/137 , A61K31/5513 , Y10T29/49826
摘要： A unit dosage form, such as a capsule or the like, for delivering a skeletal muscle relaxant, such as cyclobenzaprine hydrochloride, into the body in an extended or sustained release fashion comprising one or more populations of drug-containing particles (beads, pellets, granules, etc.) is disclosed. At least one bead population exhibits a pre-designed sustained release profile. Such a drug delivery system is designed for once—daily oral administration to maintain an adequate plasma concentration—time profile, thereby providing relief of muscle spasm associated with painful musculoskeletal conditions over a 24 hour period.

6. 发明申请

US20090148532A1 Preparation of controlled release skeletal muscle relaxant dosage forms 审中-公开
标题翻译：控制释放骨骼肌松弛剂剂型的制备
公开(公告)号：US20090148532A1
公开(公告)日：2009-06-11
申请号：US12314290
申请日：2008-12-08
申请人： Gopi M. Venkatesh , James M. Clevenger , Timothy Grinstead
发明人： Gopi M. Venkatesh , James M. Clevenger , Timothy Grinstead
IPC分类号： A61K9/14 , A61K31/137
CPC分类号： A61K9/5047 , A61K9/5078 , A61K9/5089 , A61K31/137
摘要： The present invention is directed to a method of preparing an extended release pharmaceutical composition comprising cyclobenzaprine, comprising coating inert particles with a cyclobenzaprine-containing the drug layering composition and a seal coating composition to form IR beads, then coating the IR beads with an extended release coating to form ER beads.
摘要翻译：本发明涉及一种制备包含环苯扎林的延长释放药物组合物的方法，其包括用含有药物分层组合物的环苯扎林和包封组合物涂覆惰性颗粒以形成IR珠粒，然后用延长释放物涂覆IR珠粒涂层以形成ER珠。

7. 发明授权

US08137734B2 Preparation of controlled release skeletal muscle relaxant dosage forms 有权
标题翻译：控制释放骨骼肌松弛剂剂型的制备
公开(公告)号：US08137734B2
公开(公告)日：2012-03-20
申请号：US12487339
申请日：2009-06-18
申请人： Gopi M. Venkatesh , James M. Clevenger , Timothy Grinstead
发明人： Gopi M. Venkatesh , James M. Clevenger , Timothy Grinstead
IPC分类号： A61K9/28
CPC分类号： A61K9/5047 , A61K9/5078 , A61K9/5089 , A61K31/137
摘要： The present invention is directed to a method of preparing an extended release pharmaceutical composition comprising cyclobenzaprine, comprising coating inert particles with a cyclobenzaprine-containing a drug layering composition to form IR beads, then coating the IR beads with an extended-release coating to form ER beads.
摘要翻译：本发明涉及一种制备包含环苯扎林的延长释放药物组合物的方法，包括用含有环苯扎林的药物分层组合物涂覆惰性颗粒以形成IR珠粒，然后用延长释放涂层涂覆IR珠以形成ER 珠子

8. 发明申请

US20100303905A1 Orally Disintegrating Tablet Compositions of Lamotrigine 有权
标题翻译：拉莫三嗪的口腔崩解片组合物
公开(公告)号：US20100303905A1
公开(公告)日：2010-12-02
申请号：US12628677
申请日：2009-12-01
申请人： Gopi M. Venkatesh , Nehal H. Vyas , Michael Gosselin , Jin-Wang Lai
发明人： Gopi M. Venkatesh , Nehal H. Vyas , Michael Gosselin , Jin-Wang Lai
IPC分类号： A61K9/20 , A61K31/53 , C07D253/07 , A61K9/16 , A61P25/18 , A61P25/08
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。

9. 发明申请

US20090092672A1 ORALLY DISINTEGRATING TABLET COMPOSITIONS OF LAMOTRIGINE 有权
标题翻译：洛伐他汀的片剂组合物的ORALLY DISINCAGE
公开(公告)号：US20090092672A1
公开(公告)日：2009-04-09
申请号：US12166757
申请日：2008-07-02
申请人： Gopi M. Venkatesh , Nehal H. Vyas , Michael Gosselin , Jin-Wang Lai
发明人： Gopi M. Venkatesh , Nehal H. Vyas , Michael Gosselin , Jin-Wang Lai
IPC分类号： A61K31/53 , A61K9/14 , A61P25/00
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。

10. 发明授权

US07048945B2 Timed pulsatile drug delivery systems 有权
公开(公告)号：US07048945B2
公开(公告)日：2006-05-23
申请号：US10675656
申请日：2003-09-30
申请人： Phillip J. Percel , Krishna S. Vishnupad , Gopi M. Venkatesh , Der Yang Lee
发明人： Phillip J. Percel , Krishna S. Vishnupad , Gopi M. Venkatesh , Der Yang Lee
IPC分类号： A61K9/26 , A61K9/40
CPC分类号： A61K9/5073 , A61K9/5078 , A61K9/5084 , A61K31/18
摘要： A pharmaceutical dosage form such as a capsule capable of delivering therapeutic agents into the body in a time-controlled or position-controlled pulsatile release fashion, is composed of a multitude of multicoated particulates (beads, pellets, granules, etc.) made of one or more populations of beads. Each of these beads except an immediate release bead has at least two coated membrane barriers. One of the membrane barriers is composed of an enteric polymer while the second membrane barrier is composed of a mixture of water insoluble polymer and an enteric polymer. The composition and the thickness of the polymeric membrane barriers determine the lag time and duration of drug release from each of the bead populations. Optionally, an organic acid containing intermediate membrane may be applied for further modifying the lag time and/or the duration of drug release. The pulsatile delivery may comprise one or more pulses to provide a plasma concentration-time profile for a therapeutic agent, predicted based on both its pharmaco-kinetic and pharmaco-dynamic considerations and in vitro/in vivo correlations.

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