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21. 发明授权

US08951996B2 17-hydroxyprogesterone ester-containing oral compositions and related methods 有权
标题翻译：含有17-羟孕酮酯的口腔用组合物及相关方法
公开(公告)号：US08951996B2
公开(公告)日：2015-02-10
申请号：US13193571
申请日：2011-07-28
申请人： Chandrashekar Giliyar , Srinivasan Venkateshwaran , Basawaraj Chickmath , Satish Kumar Nachaegari , Chidambaram Nachiappan , Mahesh V. Patel
发明人： Chandrashekar Giliyar , Srinivasan Venkateshwaran , Basawaraj Chickmath , Satish Kumar Nachaegari , Chidambaram Nachiappan , Mahesh V. Patel
IPC分类号： A61K31/56 , A61K9/48 , A61K31/57 , A61K9/20 , A61K9/14 , A61K9/16
CPC分类号： A61K31/57 , A61K8/63 , A61K9/0053 , A61K9/14 , A61K9/145 , A61K9/1617 , A61K9/1623 , A61K9/1635 , A61K9/1641 , A61K9/1652 , A61K9/1676 , A61K9/2013 , A61K9/2018 , A61K9/2031 , A61K9/2054 , A61K9/2059 , A61K9/4841 , A61K9/4858 , A61K9/4866 , A61K47/10 , A61K47/12 , A61K47/14 , A61K47/20 , A61K47/22 , A61K47/26 , A61K47/32 , A61K47/44 , A61K2800/10 , A61Q11/00
摘要： The present invention provides for bioavailable oral dosage forms containing esters of 17-hydroxyprogesterone as well as related methods. The oral dosage forms can be formulated for pregnancy support and can include a therapeutically effective amount of an ester of 17-hydroxyprogesterone and a pharmaceutically acceptable carrier. In another embodiment, a pharmaceutically acceptable oral dosage form for pregnancy support is provided. The pharmaceutically acceptable oral dosage can include a therapeutically effective amount of an ester of 17-hydroxyprogesterone and a pharmaceutically acceptable carrier. The oral dosage form can, when measured using a USP Type-II dissolution apparatus in 900 mL of deionized water with 0.5 (w/v) of sodium lauryl sulfate at 50 RPM at 37° C., release at least 20 wt % of the dose of the ester of 17-hydroxyprogesterone after 60 minutes, or in the alternative release at least 20 wt % more after 60 minutes than an equivalently dosed oral dosage form without the carrier.
摘要翻译：本发明提供含有17-羟孕酮酯的生物可利用的口服剂型以及相关方法。口服剂型可以配制用于妊娠支持，并且可以包括治疗有效量的17-羟孕酮和药学上可接受的载体的酯。在另一个实施方案中，提供了用于妊娠支持的药学上可接受的口服剂型。药学上可接受的口服剂量可以包括治疗有效量的17-羟孕酮和可药用载体的酯。口服剂型可以使用USP Type-II溶出装置在90mL的90RPM的90mL去离子水和0.5（w / v）十二烷基硫酸钠的条件下测量，在37℃下以50RPM释放至少20wt％ 60分钟后17-羟孕酮酯的剂量，或在替代释放中60分钟后至少20重量％比不含载体的等效给药口服剂型更多。

22. 发明申请

US20140377317A1 17-HYDROXYPROGESTERONE ESTER CONTAINING ORAL COMPOSITIONS AND RELATED METHODS 有权
标题翻译：含有口服组合物的17-羟基孕酮酯及相关方法
公开(公告)号：US20140377317A1
公开(公告)日：2014-12-25
申请号：US14477771
申请日：2014-09-04
申请人： Chandrashekar Giliyar , Srinivasan Venkateshwaran , Basawaraj Chickmath , Satish Kumar Nachaegari , Chidambaram Nachiappan , Mahesh V. Patel
发明人： Chandrashekar Giliyar , Srinivasan Venkateshwaran , Basawaraj Chickmath , Satish Kumar Nachaegari , Chidambaram Nachiappan , Mahesh V. Patel
IPC分类号： A61K8/63 , A61Q11/00
CPC分类号： A61K31/57 , A61K8/63 , A61K9/0053 , A61K9/14 , A61K9/145 , A61K9/1617 , A61K9/1623 , A61K9/1635 , A61K9/1641 , A61K9/1652 , A61K9/1676 , A61K9/2013 , A61K9/2018 , A61K9/2031 , A61K9/2054 , A61K9/2059 , A61K9/4841 , A61K9/4858 , A61K9/4866 , A61K47/10 , A61K47/12 , A61K47/14 , A61K47/20 , A61K47/22 , A61K47/26 , A61K47/32 , A61K47/44 , A61K2800/10 , A61Q11/00
摘要： The present invention provides for bioavailable oral dosage forms containing esters of 17-hydroxyprogesterone as well as related methods. The oral dosage forms can be formulated for pregnancy support and can include a therapeutically effective amount of an ester of 17-hydroxyprogesterone and a pharmaceutically acceptable carrier. In another embodiment, a pharmaceutically acceptable oral dosage form for pregnancy support is provided. The pharmaceutically acceptable oral dosage can include a therapeutically effective amount of an ester of 17-hydroxyprogesterone and a pharmaceutically acceptable carrier. The oral dosage form can, when measured using a USP Type-II dissolution apparatus in 900 mL of deionized water with 0.5 (w/v) of sodium lauryl sulfate at 50 RPM at 37° C., release at least 20 wt % of the dose of the ester of 17-hydroxyprogesterone after 60 minutes, or in the alternative release at least 20 wt % more after 60 minutes than an equivalently dosed oral dosage form without the carrier.
摘要翻译：本发明提供含有17-羟孕酮酯的生物可利用的口服剂型以及相关方法。口服剂型可以配制用于妊娠支持，并且可以包括治疗有效量的17-羟孕酮和药学上可接受的载体的酯。在另一个实施方案中，提供了用于妊娠支持的药学上可接受的口服剂型。药学上可接受的口服剂量可以包括治疗有效量的17-羟孕酮和可药用载体的酯。口服剂型可以使用USP Type-II溶出装置在90mL的90RPM的90mL去离子水和0.5（w / v）十二烷基硫酸钠的条件下，在37℃下以50RPM释放至少20wt％ 60分钟后17-羟孕酮酯的剂量，或在替代释放中60分钟后至少20重量％比不含载体的等效给药口服剂型更多。

23. 发明申请

US20130172381A1 ORAL DOSAGE FORMS FOR OXYGEN-CONTAINING ACTIVE AGENTS AND OXYL-CONTAINING POLYMER 审中-公开
标题翻译：含氧活性剂和含OYYY聚合物的口服剂型
公开(公告)号：US20130172381A1
公开(公告)日：2013-07-04
申请号：US13342883
申请日：2012-01-03
申请人： Chandrashekar Giliyar , Satish Kumar Nachaegari , Chidambaram Nachiappan , Mahesh V. Patel , Srinivansan Venkateshwaran
发明人： Chandrashekar Giliyar , Satish Kumar Nachaegari , Chidambaram Nachiappan , Mahesh V. Patel , Srinivansan Venkateshwaran
IPC分类号： A61K31/485 , A61P11/14 , A61P11/00 , A61P11/02
CPC分类号： A61K31/485 , A61K9/0053 , A61K9/2054 , A61K31/09 , A61K31/137 , A61K31/194 , A61K31/4402 , A61K45/06 , A61K2300/00
摘要： The disclosed invention is drawn to pharmaceutical tablets that provide delivery of active agents having at least three oxygen-containing groups, as well as a second active ingredient. Non-limiting examples of three oxygen-containing group active agents include guaifenesin, codeine, hydrocodone, and their pharmaceutically acceptable salts. In one embodiment, a pharmaceutical tablet for oral administration once every 12 hours is provided. The tablet includes a first active agent that is a tri-oxy active agent, a second active agent, and a release rate controlling non-ionic oxyl-containing hydrophilic polymer. The total oxyl content of the hydrophilic polymer in the tablet is about 4×10−4 moles to about 2.0×10−3 moles.
摘要翻译：所公开的发明涉及提供具有至少三个含氧基团的活性剂以及第二活性成分的药物片剂。三种含氧基活性剂的非限制性实例包括愈创甘油醚，可待因，氢可酮及其药学上可接受的盐。在一个实施方案中，提供了每12小时一次口服给药的药物片剂。片剂包括第一活性剂，其为三氧基活性剂，第二活性剂和释放速率控制非离子含氧基的亲水性聚合物。片剂中亲水性聚合物的总氧基含量为约4×10 -4摩尔至约2.0×10 -3摩尔。

24. 发明申请

US20110312928A1 Progesterone Containing Oral Dosage Forms and Related Methods 审中-公开
标题翻译：孕激素含有口服剂型及相关方法
公开(公告)号：US20110312928A1
公开(公告)日：2011-12-22
申请号：US13204562
申请日：2011-08-05
申请人： Satish Kumar Nachaegari , Chandrashekar Giliyar , Chidambaram Nachiappan , Mahesh V. Patel , Srinivasan Venkateshwaran
发明人： Satish Kumar Nachaegari , Chandrashekar Giliyar , Chidambaram Nachiappan , Mahesh V. Patel , Srinivasan Venkateshwaran
IPC分类号： A61K31/57 , A61P15/00 , A61P15/18 , A61P15/16 , A61P35/00 , A61P19/10
CPC分类号： A61K31/57 , A61K9/2013 , A61K9/2018 , A61K9/2054 , A61K9/2077 , A61K9/209 , A61K9/2846 , A61K9/4808 , A61K9/4858 , A61K9/4866
摘要： The present invention provides for progesterone containing pharmaceutical oral dosage forms and related methods. The oral dosage forms can each include an amount of progesterone as well as a pharmaceutically acceptable carrier. The oral dosage forms can be formulated to have at least one of the following characteristics: the oral dosage form produces an pregnane metabolite mean blood plasma level of less than about 1000 nmol/L; the oral dosage form produces an pregnane metabolites mean blood plasma level, after administration of single dose of progesterone composition, such that the ratio of pregnane metabolite level to parent progesterone level of less than 10:1; has a dissolution rate in vitro, when measure using a USP Type-1 dissolution apparatus in 900 mL of deionized water with 2.0% (w/v) of sodium lauryl sulfate at 100 rpm, such that the oral dosage form releases at least 10 wt % of the progesterone within the first 30 minutes and/or releases less than 45 wt % in the first 4 hours; and the oral dosage form produces a ratio of mean plasma progesterone AUC to the amount of progesterone administered of more than 1.5×10−6 hr/mL:1.
摘要翻译：本发明提供含有孕酮的药物口服剂型和相关方法。口服剂型各自可以包含一定量的孕酮以及药学上可接受的载体。口服剂型可以配制成具有以下特征中的至少一种：口服剂型产生的孕代谢物平均血浆水平低于约1000nmol / L; 口服剂型产生孕烷代谢物平均血浆水平，施用单次孕酮组合物后，孕妇代谢物水平与母体孕酮水平的比例小于10：1; 当使用USP1型溶出装置在900mL具有2.0％（w / v）月桂基硫酸钠的去离子水中以100rpm进行测量时，其体外溶出速率使得口服剂型释放至少10重量％在前30分钟内孕酮的百分比和/或在前4小时内释放小于45重量％并且口服剂型产生平均血浆孕酮AUC与施用孕酮量的比例大于1.5×10-6hr / mL：1。

25. 发明申请

US20110142945A1 Hydrophobic Active Agent Compositions and Related Methods 审中-公开
标题翻译：疏水活性剂组合物及相关方法
公开(公告)号：US20110142945A1
公开(公告)日：2011-06-16
申请号：US13029989
申请日：2011-02-17
申请人： Feng-Jing Chen , Kathryn Gutke , Srinivasan Venkateshwaran , Mahesh V. Patel
发明人： Feng-Jing Chen , Kathryn Gutke , Srinivasan Venkateshwaran , Mahesh V. Patel
IPC分类号： A61K9/14 , A61K31/5685
CPC分类号： A61K38/13 , A61K9/4858 , A61K9/4866
摘要： Compositions and methods for providing hydrophobic active agents in a bioavailable form are disclosed and described. In one aspect of the invention, pharmaceutical composition containing a testosterone ester is provided. The composition includes a testosterone ester in both dissolved form and as undissolved particles and the dissolved form comprises at least 35 wt % of the testosterone ester present in the composition. The composition further includes a solubilizer and a stabilizer.
摘要翻译：公开和描述了以生物可利用形式提供疏水性活性剂的组合物和方法。在本发明的一个方面，提供了含有睾酮酯的药物组合物。组合物包括溶解形式的睾酮酯和未溶解的颗粒，溶解形式包含组合物中存在的至少35重量％的睾酮酯。组合物还包括增溶剂和稳定剂。

26. 发明授权

US07164023B2 Benzoquinolizine-2-carboxylic acid arginine salt tetrahydrate 有权
公开(公告)号：US07164023B2
公开(公告)日：2007-01-16
申请号：US10749932
申请日：2003-12-31
申请人： Prasad K. Deshpande , Vijaya N. Desai , Ravindra D. Yeole , Shrikant V. Gupte , Mahesh V. Patel , Noel J. de Souza
发明人： Prasad K. Deshpande , Vijaya N. Desai , Ravindra D. Yeole , Shrikant V. Gupte , Mahesh V. Patel , Noel J. de Souza
IPC分类号： C07D401/04 , C07D401/14
CPC分类号： C07D471/06
摘要： The invention relates to crystalline S-(−)-9-fluoro-6,7-dihydro-8-(4-hydroxypiperidin-1-yl)-5-methyl-1-oxo-1H,5H-benzo[i,j]quinolizine-2-carboxylic acid L-arginine salt tetrahydrate, a process for its preparation and pharmaceutical formulations incorporating it as the active ingredient for use in treating microbial infections.

27. 发明授权

US06982281B1 Pharmaceutical compositions and dosage forms for administration of hydrophobic drugs 失效
标题翻译：用于施用疏水性药物的药物组合物和剂型
公开(公告)号：US06982281B1
公开(公告)日：2006-01-03
申请号：US09716029
申请日：2000-11-17
申请人： Feng-Jing Chen , Mahesh V. Patel
发明人： Feng-Jing Chen , Mahesh V. Patel
IPC分类号： A61K31/355 , A61K31/35 , A61K31/235 , A61K9/48 , A61K9/66
CPC分类号： A61K9/0095 , A61K9/1075 , A61K9/4858 , A61K31/216 , A61K47/22 , B82Y5/00
摘要： Pharmaceutical compositions and dosage forms for administration of hydrophobic drugs, particularly fenofibrate, are provided. The compositions comprise a therapeutically effective amount of an active agent and a solubilizer. The solubilizer is selected to effectively solubilize active agent in the composition. The solubilizers employed as part of the invention include: a vitamin E substance; monohydric alcohol esters such as trialkyl citrates, lactones and lower alcohol fatty acid esters; nitrogen-containing solvents; phospholipids; glycerol acetates such as acetin, diacetin and triacetin; glycerol fatty acid esters such as mono-, di- and triglycerides and acetylated mono- and diglycerides; propylene glycol esters; ethylene glycol esters; and combinations thereof. The pharmaceutical dosage forms contain the compositions in a suitable dosage form unit such as a capsule. Methods of treating patients comprising administering the compositions are also provided.
摘要翻译：提供了用于给药疏水药物，特别是非诺贝特的药物组合物和剂型。组合物包含治疗有效量的活性剂和增溶剂。选择增溶剂以有效地增溶组合物中的活性剂。用作本发明一部分的增溶剂包括：维生素E物质; 一元醇酯如柠檬酸三烷基酯，内酯和低级醇脂肪酸酯; 含氮溶剂; 磷脂; 乙酸甘油酯，如乙酸乙酯，二醋精和三醋精; 甘油脂肪酸酯，例如甘油单酯，甘油二酯和甘油三酯和乙酰化甘油单酯和甘油二酯; 丙二醇酯; 乙二醇酯; 及其组合。药物剂型含有合适的剂型单位例如胶囊的组合物。还提供了治疗包括给予组合物的患者的方法。

28. 发明授权

US06458383B2 Pharmaceutical dosage form for oral administration of hydrophilic drugs, particularly low molecular weight heparin 失效
标题翻译：用于口服给予亲水药物，特别是低分子量肝素的药物剂型
公开(公告)号：US06458383B2
公开(公告)日：2002-10-01
申请号：US09751968
申请日：2000-12-29
申请人： Feng-Jing Chen , Mahesh V. Patel , David T. Fikstad
发明人： Feng-Jing Chen , Mahesh V. Patel , David T. Fikstad
IPC分类号： A61K948
CPC分类号： A61K9/5073 , A61K9/1075 , A61K9/4858 , A61K9/4891 , Y10S514/937 , Y10S514/938 , Y10S514/939 , Y10S514/94 , Y10S514/941 , Y10S514/942 , Y10S514/943 , Y10S514/975
摘要： A delayed release pharmaceutical dosage form for oral administration of a hydrophilic drug, e.g., a polysaccharide drug such as low molecular weight heparin, are provided. The dosage form comprises a composition of: (a) a therapeutically effective amount of low molecular weight heparin; (b) a bile salt or bile acid; (c) at least one surfactant selected from hydrophilic surfactants, lipophilic surfactants, and mixtures thereof; and a means for delaying release of the composition from the dosage form following oral administration. Osmotic drug delivery systems for oral administration of a hydrophilic drug are also provided, wherein an osmotically activated device houses the drug, a bile salt or bile acid, and at least one surfactant selected from the group consisting of hydrophilic surfactants, lipophilic surfactants, and mixtures thereof. Methods for administering hydrophilic drugs, particularly polysaccharide drugs such as low molecular weight heparin, are also provided.
摘要翻译：提供用于口服给予亲水药物的延迟释放药物剂型，例如多糖药物如低分子量肝素。剂型包含以下组合物：（a）治疗有效量的低分子量肝素; （b）胆汁盐或胆汁酸; （c）至少一种选自亲水性表面活性剂，亲脂性表面活性剂及其混合物的表面活性剂; 以及在口服给药后延迟组合物从剂型释放的手段。还提供了用于口服给药亲水药物的渗透药物递送系统，其中渗透活化的装置容纳药物，胆汁盐或胆汁酸，以及选自亲水性表面活性剂，亲脂性表面活性剂和混合物中的至少一种表面活性剂其中。还提供了用于给予亲水药物，特别是多糖药物如低分子量肝素的方法。

29. 发明授权

US06383471B1 Compositions and methods for improved delivery of ionizable hydrophobic therapeutic agents 有权
标题翻译：用于改善可电离疏水治疗剂递送的组合物和方法
公开(公告)号：US06383471B1
公开(公告)日：2002-05-07
申请号：US09287043
申请日：1999-04-06
申请人： Feng-Jing Chen , Mahesh V. Patel
发明人： Feng-Jing Chen , Mahesh V. Patel
IPC分类号： A61K912
CPC分类号： A61K9/1075 , A61K9/485 , A61K9/4858 , A61K47/02 , Y10S514/944
摘要： The present invention is directed to a pharmaceutical composition including a hydrophobic therapeutic agent having at least one ionizable functional group, and a carrier. The carrier includes an ionizing agent capable of ionizing the functional group, a surfactant, and optionally solubilizers, triglycerides, and neutralizing agents. The invention further relates to a method of preparing such compositions by providing a composition of an ionizable hydrophobic therapeutic agent, an ionizing agent, and a surfactant, and neutralizing a portion of the ionizing agent with a neutralizing agent. The compositions of the invention are particularly suitable for use in oral dosage forms.
摘要翻译：本发明涉及包含具有至少一个可离子化官能团的疏水性治疗剂和载体的药物组合物。载体包括能够离子化官能团的电离剂，表面活性剂和任选的增溶剂，甘油三酯和中和剂。本发明还涉及通过提供可离子化的疏水性治疗剂，离子化剂和表面活性剂的组合物和用中和剂中和一部分电离剂来制备这种组合物的方法。本发明的组合物特别适用于口服剂型。

30. 发明授权

US06248363B1 Solid carriers for improved delivery of active ingredients in pharmaceutical compositions 有权
标题翻译：用于改善药物组合物中活性成分递送的固体载体
公开(公告)号：US06248363B1
公开(公告)日：2001-06-19
申请号：US09447690
申请日：1999-11-23
申请人： Mahesh V. Patel , Feng-Jing Chen
发明人： Mahesh V. Patel , Feng-Jing Chen
IPC分类号： A61K916
CPC分类号： A61K47/14 , A61K9/1617 , A61K9/1676 , A61K9/4858 , A61K9/5015 , A61K9/5026 , A61K9/5078 , A61K9/5084 , A61K31/352 , A61K31/4709 , A61K31/496 , A61K31/5383 , A61K31/5513 , A61K31/568 , A61K31/7048 , A61K47/10 , B82Y5/00 , Y02A50/463 , Y10S977/906 , Y10S977/927
摘要： The present invention provides solid pharmaceutical compositions for improved delivery of a wide variety of pharmaceutical active ingredients contained therein or separately administered. In one embodiment, the solid pharmaceutical composition includes a solid carrier, the solid carrier including a substrate and an encapsulation coat on the substrate. The encapsulation coat can include different combinations of pharmaceutical active ingredients, hydrophilic surfactant, lipophilic surfactants and triglycerides. In another embodiment, the solid pharmaceutical composition includes a solid carrier, the solid carrier being formed of different combinations of pharmaceutical active ingredients, hydrophilic surfactants, lipophilic surfactants and triglycerides. The compositions of the present invention can be used for improved delivery of hydrophilic or hydrophobic pharmaceutical active ingredients, such as drugs, nutrionals, cosmeceuticals and diagnostic agents.
摘要翻译：本发明提供用于改善递送其中所含的各种药物活性成分或单独施用的固体药物组合物。在一个实施方案中，固体药物组合物包括固体载体，固体载体包括底物和基材上的包封涂层。包封涂层可以包括药物活性成分，亲水性表面活性剂，亲脂性表面活性剂和甘油三酯的不同组合。在另一个实施方案中，固体药物组合物包括固体载体，固体载体由药物活性成分，亲水性表面活性剂，亲脂性表面活性剂和甘油三酸酯的不同组合形成。本发明的组合物可用于改善递送亲水或疏水性药物活性成分，例如药物，营养成分，药妆和诊断剂。

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