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1. 发明申请

US20150320686A1 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：US20150320686A1
公开(公告)日：2015-11-12
申请号：US14720366
申请日：2015-05-22
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： A61K9/20 , A61K31/485 , A61K31/09
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。

2. 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。

3. 发明申请

US20150087666A1 ORAL DOSAGE FORMS FOR OXYGEN CONTAINING ACTIVE AGENTS AND OXYL-CONTAINING POLYMERS 有权
标题翻译：含有活性剂和含OYYY聚合物的含氧化合物的口服剂型
公开(公告)号：US20150087666A1
公开(公告)日：2015-03-26
申请号：US14555043
申请日：2014-11-26
申请人： Chandrashekar Giliyar , Satish Kumar Nachaegari , Chidambaram Nachiappan , Mahesh V. Patel , Srinivasan Venkateshwaran
发明人： Chandrashekar Giliyar , Satish Kumar Nachaegari , Chidambaram Nachiappan , Mahesh V. Patel , Srinivasan Venkateshwaran
IPC分类号： A61K31/485 , A61K31/194 , A61K31/4402
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, a tri-oxy active agent, 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 from about 4×10−4 moles to about 2.0×10−3 moles. The tablet is a matrix tablet and a single-dose administration of one or more tablets to a subject under fasted conditions provides a mean Cmax for each of the first active agent and the second active agent that is 70% to 135% of a respective mean Cmax provided by administering an immediate release oral dosage form to a subject under fasted conditions every 4 to 6 hours over a 12 hour time period, wherein cumulative dosage amounts administered over the 12 hour time period of each active agent is equivalent to the respective amount of each active agent in the pharmaceutical tablet.
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，三氧基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。片剂是基质片剂，并且在禁食条件下向受试者单剂量施用一种或多种片剂提供了每种第一活性剂和第二活性剂的平均C max，其为相应平均值的70％至135％ Cmax通过在禁食状态下每隔4〜6小时在12小时时间内向受试者施用立即释放的口服剂型，其中在每个活性剂的12小时时间段内施用的累积剂量相当于药物片剂中的每种活性剂。

4. 发明申请

US20130029957A1 17-Hydroxyprogesterone Ester-Containing Oral Compositions and Related Methods 有权
公开(公告)号：US20130029957A1
公开(公告)日：2013-01-31
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 , A61P15/00
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.

5. 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。

6. 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。

7. 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。

8. 发明申请

US20120244215A1 HIGH-STRENGTH TESTOSTERONE UNDECANOATE COMPOSITIONS 有权
标题翻译：高强度试验机组合物
公开(公告)号：US20120244215A1
公开(公告)日：2012-09-27
申请号：US13485807
申请日：2012-05-31
申请人： Chandrashekar Giliyar , Basawaraj Chickmath , Chidambaram Nachiappan , Mahesh V. Patel , Srinivansan Venkateshwaran
发明人： Chandrashekar Giliyar , Basawaraj Chickmath , Chidambaram Nachiappan , Mahesh V. Patel , Srinivansan Venkateshwaran
IPC分类号： A61K9/48 , A61P15/08 , A61K31/568
CPC分类号： A61K31/568 , A61K9/0053 , A61K9/4858 , A61K9/4875 , A61K47/12 , A61K47/22 , A61K47/44 , G01N33/743
摘要： The present disclosure is drawn to pharmaceutical compositions and oral dosage capsules containing testosterone undecanoate, as well as related methods. The capsule includes a capsule shell and a capsule fill. The capsule fill can include a solubilizer and about 14 wt % to about 35 wt % testosterone undecanoate based on the total capsule fill. The oral dosage capsule is such that when a single oral administration to a male subject of one or more capsules with a total testosterone undecanoate daily dose of about 350 mg to about 650 mg it provides a ratio of serum testosterone Cmax to serum testosterone Cave of about 2.7 or less. In yet another embodiment, a method for providing a serum concentration of testosterone within a target serum testosterone concentration Cave range for a male subject is provided.
摘要翻译：本公开涉及含有十一酸睾酮的药物组合物和口服剂量胶囊以及相关方法。胶囊包括胶囊壳和胶囊填充物。基于总胶囊填充，胶囊填充物可以包含增溶剂和约14重量％至约35重量％的十一酸睾酮。口服剂量胶囊使得当向男性受试者单次口服给予一种或多种具有总睾酮十一烷酸酯的胶囊剂，每日剂量约350mg至约650mg时，其提供血清睾酮C max与血清睾酮的比例约为 2.7以下。在另一个实施方案中，提供了一种用于在目标血清睾酮浓度范围内为男性受试者提供睾酮血清浓度的方法。

9. 发明申请

US20120135074A1 High-Strength Testosterone Undecanoate Compositions 审中-公开
标题翻译：高强度睾酮非特异性组合物
公开(公告)号：US20120135074A1
公开(公告)日：2012-05-31
申请号：US12957206
申请日：2010-11-30
申请人： Chandrashekar Giliyar , Basawaraj Chickmath , Chidambaram Nachiappan , Mahesh V. Patel , Srinivansan Venkateshwaran
发明人： Chandrashekar Giliyar , Basawaraj Chickmath , Chidambaram Nachiappan , Mahesh V. Patel , Srinivansan Venkateshwaran
IPC分类号： A61K9/52 , A61K9/48 , A61P15/00 , A61K31/568
CPC分类号： A61K31/568 , A61K9/148 , A61K9/4875 , A61K47/12
摘要： The present disclosure is drawn to pharmaceutical compositions and oral dosage capsules containing testosterone undecanoate, as well as related methods of treatment. In one embodiment, the present invention provides for a pharmaceutical composition that includes a therapeutically effective amount of testosterone undecanoate and a solubilizer. The testosterone undecanoate is solubilized in the composition and is present in an amount such that it comprises about 14 wt % to about 35 wt % of the total composition.
摘要翻译：本公开涉及含有十一酸睾酮的药物组合物和口服剂量胶囊以及相关的治疗方法。在一个实施方案中，本发明提供了包含治疗有效量的十一酸睾酮和增溶剂的药物组合物。十一酸睾酮被溶解在组合物中，并且存在的量使得它占总组合物的约14重量％至约35重量％。

10. 发明申请

US20120148675A1 TESTOSTERONE UNDECANOATE COMPOSITIONS 审中-公开
标题翻译：未成熟组合物的TESTOSTERONE
公开(公告)号：US20120148675A1
公开(公告)日：2012-06-14
申请号：US12965703
申请日：2010-12-10
申请人： Basawaraj Chickmath , Chandrashekar Giliyar , Chidambaram Nachiappan , Mahesh V. Patel , Srinivansan Venkateshwaran
发明人： Basawaraj Chickmath , Chandrashekar Giliyar , Chidambaram Nachiappan , Mahesh V. Patel , Srinivansan Venkateshwaran
IPC分类号： A61K31/568 , A61P19/00 , A61P15/10 , A61K9/14 , A61P5/26
CPC分类号： A61K9/2031 , A61K9/14 , A61K9/146 , A61K9/148 , A61K9/1652 , A61K9/1676 , A61K9/1694 , A61K9/2013 , A61K9/2018 , A61K9/205 , A61K9/2054 , A61K9/282 , A61K9/2853 , A61K9/286 , A61K9/2866 , A61K9/4866 , A61K9/4875 , A61K31/568 , A61K47/10 , A61K47/36 , A61K47/38 , A61K47/40
摘要： The present disclosure is drawn to pharmaceutical compositions and oral dosage forms containing testosterone undecanoate, as well as related methods of treatment. In one embodiment, the oral dosage form can include a therapeutically effective amount of testosterone undecanoate and a pharmaceutically acceptable carrier. The dosage form can be formulated such that, when measured using a USP Type II apparatus in 1000 mL of 8 wt % Triton X-100 in water at 37° C. and 100 rpm, the oral dosage form releases at least 20% more testosterone undecanoate after the first 120 minutes than an equivalent dose testosterone undecanoate containing oral dosage form without the pharmaceutically acceptable carrier.
摘要翻译：本公开涉及含有十一酸睾酮的药物组合物和口服剂型，以及相关的治疗方法。在一个实施方案中，口服剂型可以包括治疗有效量的十一酸睾酮和药学上可接受的载体。可以配制剂型，使得当使用USP II型装置在1000mL的8重量％Triton X-100在水中在37℃和100rpm下测量时，口服剂型释放至少20％以上的睾酮十一酸十一酸酯比不含药学上可接受的载体的含有口服剂型的等效剂量十一酸睾酮。

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