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11. 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。

12. 发明申请

US20090155360A1 ORALLY DISINTEGRATING TABLETS COMPRISING DIPHENHYDRAMINE 审中-公开
标题翻译：包含二苯甲酰胺的外用消毒片
公开(公告)号：US20090155360A1
公开(公告)日：2009-06-18
申请号：US12331963
申请日：2008-12-10
申请人： Gopi M. VENKATESH , Jin-Wang Lai , Phillip Percel , Craig Kramer
发明人： Gopi M. VENKATESH , Jin-Wang Lai , Phillip Percel , Craig Kramer
IPC分类号： A61K9/20 , A61K9/16 , A61K31/135
CPC分类号： A61K9/5078 , A61K9/0056 , A61K9/2018 , A61K9/2027 , A61K9/2054 , A61K9/2077 , A61K9/5047 , A61K31/135 , A61K45/06
摘要： The compositions of the present invention comprise a therapeutically effective amount of particles consisting of diphenhydramine or pharmaceutically acceptable salts thereof, optionally in combination with another drug such as pseudoephedrine, or phenylephrine and hydrocodone, in combination with rapidly-dispersing microgranules comprising a disintegrant and a sugar alcohol and/or a saccharide. These compositions are useful in treating the symptoms of one or more diseases or conditions in which diphenhydramine (alone or in combination with one or two other drugs) is a therapeutically effective, e.g. allergic rhinitis, sinusitis, upper respiratory tract infections, motion sickness, Parkinson's disease, insomnia, the common cold, and nighttime pain management, particularly for subjects or patients with dysphagia, and people ‘on the move’.
摘要翻译：本发明的组合物包含治疗有效量的由苯海拉明或其药学上可接受的盐组成的颗粒，任选地与另一种药物如伪麻黄碱或去氧肾上腺素和氢可酮组合，与包含崩解剂和糖的快速分散的微粒组合醇和/或糖。这些组合物可用于治疗其中苯海拉明（单独或与一种或两种其它药物组合）治疗有效的一种或多种疾病或病症的症状，例如，过敏性鼻炎，鼻窦炎，上呼吸道感染，运动病，帕金森病，失眠，普通感冒和夜间疼痛管理，特别是对于受试者或吞咽困难的患者，以及人们的“移动”。

13. 发明授权

US08647656B2 Orally disintegrating tablet compositions of lamotrigine 有权
公开(公告)号：US08647656B2
公开(公告)日：2014-02-11
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： A61K9/46 , A61K9/26
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.

14. 发明授权

US09572781B2 Orally disintegrating tablet compositions comprising combinations of non-opioid and opioid analgesics 有权
标题翻译：口服崩解片剂组合物，其包含非阿片样物质和阿片样镇痛药的组合
公开(公告)号：US09572781B2
公开(公告)日：2017-02-21
申请号：US12772776
申请日：2010-05-03
申请人： Gopi Venkatesh , Michael Gosselin , James Clevenger , Jin-Wang Lai
发明人： Gopi Venkatesh , Michael Gosselin , James Clevenger , Jin-Wang Lai
IPC分类号： A61K9/16 , A61K9/50
CPC分类号： A61K9/5047 , A61K9/2081 , A61K9/5073 , A61K9/5078 , A61K9/5084 , A61K31/00 , A61K31/192 , A61K31/196 , A61K31/40 , A61K31/405 , A61K31/407 , A61K31/415 , A61K31/4415 , A61K31/4468 , A61K31/485 , A61K31/5415 , A61K31/60 , A61K45/06 , A61K2300/00
摘要： The present invention is directed to pharmaceutical compositions comprising a plurality of taste-masked non-opioid analgesic/opioid analgesic drug-containing microparticles, dosage forms comprising such pharmaceutical compositions (such as an orally disintegrating tablet), and methods of making the pharmaceutical compositions and dosage forms of the present invention. Dosage forms comprising the pharmaceutical compositions of the present invention are improved homogeneous blends of non-opioid and opioid analgesics which provide for more convenient and palatable administration of drug combinations, for example for treating pain.
摘要翻译：本发明涉及包含多种掩味的非阿片类镇痛/阿片类止痛药物的微粒的药物组合物，包含这种药物组合物的剂型（例如口腔崩解片），以及制备该药物组合物的方法和本发明的剂型。包含本发明的药物组合物的剂型是非阿片类和阿片类止痛剂的改进的均匀共混物，其提供药物组合的更方便和可口的给药，例如用于治疗疼痛。

15. 发明授权

US08133506B2 Drug delivery systems comprising weakly basic drugs and organic acids 有权
标题翻译：包括弱碱性药物和有机酸的药物递送系统
公开(公告)号：US08133506B2
公开(公告)日：2012-03-13
申请号：US12209285
申请日：2008-09-12
申请人： Gopi Venkatesh , Jin-Wang Lai , Nehal H. Vyas , Vivek Purohit
发明人： Gopi Venkatesh , Jin-Wang Lai , Nehal H. Vyas , Vivek Purohit
IPC分类号： A61K9/48 , A61K9/16 , A61K31/4178
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，难溶性的药物，并且释放至少约80wt。当使用美国药典（USP）溶出方法进行溶出测试时，约5分钟内弱碱性，溶解性差的药物的百分比（装置2-桨叶，50RPM，两步溶解培养基在37℃（前2小时 0.1N HCl，然后在pH 6.8的缓冲液中测试）。

16. 发明授权

US07833547B2 Ibuprofen and narcotic analgesic compositions 有权
标题翻译：布洛芬和麻醉止痛组合物
公开(公告)号：US07833547B2
公开(公告)日：2010-11-16
申请号：US11015857
申请日：2004-12-16
申请人： Gregory P. Kushla , Jin-Wang Lai , Gerald P. Polli
发明人： Gregory P. Kushla , Jin-Wang Lai , Gerald P. Polli
IPC分类号： A61K9/20
CPC分类号： A61K31/485 , A61K9/2009 , A61K9/2054 , A61K9/2059 , A61K9/2077 , A61K33/00 , Y10S514/96 , A61K31/19 , A61K2300/00
摘要： Provided herein are compositions and methods of making compositions of ibuprofen in combination with a narcotic analgesic. Specifically provided is a pharmaceutical tablet composition comprising ibuprofen; a narcotic analgesic; colloidal silicon dioxide; a filler selected from the group consisting of microcrystalline cellulose and powdered cellulose; a disintegrant selected from the group consisting of croscarmellose sodium, crospovidone, and sodium starch glycolate; a binder consisting of an akylhydroxy methylcellulose; a starch; and a lubricant. Also provided herein is a method of preparing a pharmaceutical tablet composition comprising: (a) Granulating ibuprofen, a narcotic analgesic, a first glidant, a first disintegrant, a binder, and starch to form granules wherein said granulating step comprises a wet granulation process; (b) blending the granules with extra-granular material comprised of a second glidant, a second disintegrant, a filler and starch to form a blend of granules and extra-granular material; and (c) compressing the blend into a tablet.
摘要翻译：本文提供了组合物和制备布洛芬组合物与麻醉止痛剂的组合物的方法。具体提供了包含布洛芬的药物片剂组合物; 麻醉止痛药胶态二氧化硅; 选自微晶纤维素和粉末状纤维素的填料; 选自交联羧甲基纤维素钠，交聚维酮和淀粉羟乙酸钠的崩解剂; 由烷基羟基甲基纤维素组成的粘合剂; 淀粉; 和润滑剂。本文还提供了制备药物片剂组合物的方法，其包含：（a）将布洛芬，麻醉止痛剂，第一助流剂，第一崩解剂，粘合剂和淀粉制粒以形成颗粒，其中所述造粒步骤包括湿法制粒法; （b）将颗粒与由第二助流剂，第二崩解剂，填料和淀粉组成的颗粒外材料混合以形成颗粒和颗粒外材料的混合物; 和（c）将混合物压制成片剂。

17. 发明授权

US06599531B2 Method of making ibuprofen and narcotic analgesic compositions 有权
公开(公告)号：US06599531B2
公开(公告)日：2003-07-29
申请号：US10028939
申请日：2001-12-21
申请人： Gregory P. Kushla , Jin-Wang Lai , Gerald P. Polli
发明人： Gregory P. Kushla , Jin-Wang Lai , Gerald P. Polli
IPC分类号： A61K920
CPC分类号： A61K31/192 , A61K9/2054 , A61K9/2059 , A61K31/485 , Y10S514/96 , A61K2300/00
摘要： Provided herein are compositions and methods of making compositions of ibuprofen in combination with a narcotic analgesic. Specifically provided is a pharmaceutical tablet composition comprising ibuprofen; a narcotic analgesic; colloidal silicon dioxide; a filler selected from the group consisting of microcrystalline cellulose and powdered cellulose; a disintegrant selected from the group consisting of croscarmellose sodium, crospovidone, and sodium starch glycolate; a binder consisting of an akylhydroxy methylcellulose; a starch; and a lubricant. Also provided herein is a method of preparing a pharmaceutical tablet composition comprising: (a) Granulating ibuprofen, a narcotic analgesic, a first glidant, a first disintegrant, a binder, and starch to form granules wherein said granulating step comprises a wet granulation process; (b) blending the granules with extra-granular material comprised of a second glidant, a second disintegrant, a filler and starch to form a blend of granules and extra-granular material; and (c) compressing the blend into a tablet.

18. 发明申请

US20100330150A1 Orally Disintegrating Tablet Compositions Comprising Combinations of High and Low-Dose Drugs 审中-公开
标题翻译：口服崩解片组合物组合高剂量和低剂量药物
公开(公告)号：US20100330150A1
公开(公告)日：2010-12-30
申请号：US12772770
申请日：2010-05-03
申请人： Gopi Venkatesh , Michael Gosselin , James Clevenger , Jin-Wang Lai
发明人： Gopi Venkatesh , Michael Gosselin , James Clevenger , Jin-Wang Lai
IPC分类号： A61K9/62 , A61K9/50 , A61K9/56 , A61K9/58 , A61K31/445 , A61K31/4355 , A61K31/5415 , A61K31/4965 , A61K31/4453 , A61K31/4436 , A61K31/165 , A61K31/427 , A61K31/505 , A61K31/495 , A61K31/4545 , A61K31/137 , B05D3/00 , A61P3/10 , A61P9/10 , A61P11/00
CPC分类号： A61K9/5047 , A61K9/2081 , A61K9/5073 , A61K9/5078 , A61K9/5084 , A61K31/00 , A61K31/192 , A61K31/196 , A61K31/40 , A61K31/405 , A61K31/407 , A61K31/415 , A61K31/4415 , A61K31/4468 , A61K31/485 , A61K31/5415 , A61K31/60 , A61K45/06 , A61K2300/00
摘要： The present invention is directed to pharmaceutical compositions comprising a plurality of taste-masked high-dose/low-dose drug-containing microparticles, dosage forms comprising such pharmaceutical compositions (such as an orally disintegrating tablet), and methods of making the pharmaceutical compositions and dosage forms of the present invention. Dosage forms comprising the pharmaceutical compositions of the present invention are improved homogeneous blends of high-dose and low-dose drugs which provide for more convenient and palatable administration of drug combinations, for example for treating pain, hyperglycemia, cardiovascular disease, and allergies.
摘要翻译：本发明涉及包含多个掩味的高剂量/低剂量药物的微粒的药物组合物，包含这种药物组合物（例如口腔崩解片剂）的剂型，以及制备该药物组合物的方法和本发明的剂型。包含本发明的药物组合物的剂型是改善的大剂量和低剂量药物的均匀共混物，其提供药物组合的更方便和可口的给药，例如用于治疗疼痛，高血糖症，心血管疾病和过敏症。

19. 发明申请

US20060105038A1 Taste-masked pharmaceutical compositions prepared by coacervation 审中-公开
标题翻译：通过凝聚制备的口味掩蔽的药物组合物
公开(公告)号：US20060105038A1
公开(公告)日：2006-05-18
申请号：US11213266
申请日：2005-08-26
申请人： Jin-Wang Lai , Ken Qian , Gopi Venkatesh
发明人： Jin-Wang Lai , Ken Qian , Gopi Venkatesh
IPC分类号： A61K9/26
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。

20. 发明授权

US06361794B1 Method of making ibuprofen and narcotic analgesic composition 失效
标题翻译：制备布洛芬和麻醉止痛组合物的方法
公开(公告)号：US06361794B1
公开(公告)日：2002-03-26
申请号：US08872217
申请日：1997-06-10
申请人： Gregory P. Kushla , Jin-Wang Lai , Gerald P. Polli
发明人： Gregory P. Kushla , Jin-Wang Lai , Gerald P. Polli
IPC分类号： A61K920
CPC分类号： A61K31/192 , A61K9/2054 , A61K9/2059 , A61K31/485 , Y10S514/96 , A61K2300/00
摘要： Provided herein are compositions and methods of making compositions of ibuprofen in combination with a narcotic analgesic. Specifically provided is a pharmaceutical tablet composition comprising ibuprofen; a narcotic analgesic; colloidal silicon dioxide; a filler selected from the group consisting of microcrystalline cellulose and powdered cellulose; a disintegrant selected from the group consisting of croscarmellose sodium, crospovidone, and sodium starch glycolate; a binder consisting of an akylhydroxy methylcellulose; a starch; and a lubricant. Also provided herein is a method of preparing a pharmaceutical tablet composition comprising: (a) Granulating ibuprofen, a narcotic analgesic, a first glidant, a first disintegrant, a binder, and starch to form granules wherein said granulating step comprises a wet granulation process; (b) blending the granules with extra-granular material comprised of a second glidant, a second disintegrant, a filler and starch to form a blend of granules and extra-granular material; and (c) compressing the blend into a tablet.
摘要翻译：本文提供了组合物和制备布洛芬组合物与麻醉止痛剂的组合物的方法。具体提供了包含布洛芬的药物片剂组合物; 麻醉止痛药胶态二氧化硅; 选自微晶纤维素和粉末状纤维素的填料; 选自交联羧甲基纤维素钠，交聚维酮和淀粉羟乙酸钠的崩解剂; 由烷基羟基甲基纤维素组成的粘合剂; 淀粉; 和润滑剂。本文还提供了制备药物片剂组合物的方法，其包含：（a）将布洛芬，麻醉止痛剂，第一助流剂，第一崩解剂，粘合剂和淀粉制粒以形成颗粒，其中所述造粒步骤包括湿法制粒法; （b）将颗粒与由第二助流剂，第二崩解剂，填料和淀粉组成的颗粒外材料混合以形成颗粒和颗粒外材料的混合物; 和（c）将混合物压制成片剂。

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