公开(公告)号：US20210169900A1

公开(公告)日：2021-06-10

申请号：US16927891

申请日：2020-07-13

申请人： Lipocine Inc.

发明人： Chandrashekar Giliyar ,  Srinivasan Venkateshwaran ,  Basawaraj Chickmath ,  Satish Nachaegari ,  Nachiappan Chidambaram ,  Mahesh V. Patel

IPC分类号： A61K31/57 ,  A61K9/20 ,  A61K9/00 ,  A61K9/14

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.

公开(公告)号：US20210069211A1

公开(公告)日：2021-03-11

申请号：US16849957

申请日：2020-04-15

申请人： Lipocine Inc.

发明人： Mahesh V. Patel ,  Nachiappan Chidambaram ,  Satish Kumar Nachaegari ,  Srinivasan Venkateshwaran ,  Joel Frank

IPC分类号： A61K31/568 ,  A61K39/00 ,  A61K9/00 ,  A61K9/16

摘要： Disclosed are bioavailable solid state (17-β)-Hydroxy-4-Androsten-3-one esters suitable for pharmaceutical uses and administration to mammals in need of (17-β)-Hydroxy-4-Androsten-3-one.

公开(公告)号：US20190350943A1

公开(公告)日：2019-11-21

申请号：US16367091

申请日：2019-03-27

申请人： Lipocine Inc.

发明人： Mahesh V. Patel ,  Nachiappan Chidambaram ,  Satish Kumar Nachaegari ,  Srinivasan Venkateshwaran ,  Joel Frank ,  Amy Jo Portlock

IPC分类号： A61K31/5685 ,  C07J1/00

摘要： Described here are substantially pure (17-β)-3-Oxoandrost-4-en-17-yl tridecanoate compositions, methods of their preparation and uses thereof.

公开(公告)号：US20170246187A1

公开(公告)日：2017-08-31

申请号：US15507754

申请日：2015-08-28

申请人： Lipocine Inc.

发明人： Mahesh V. Patel ,  Nachiappan Chidambaram ,  Satish Kumar Nachaegari ,  Srinivasan Venkateshwaran ,  Joel Frank ,  Amy Jo Portlock

IPC分类号： A61K31/5685 ,  C07J1/00

CPC分类号： A61K31/5685 ,  C07J1/0025

摘要： Described here are substantially pure (17-β)-3-Oxoandrost-4-en-17-yl tridecanoate compositions, methods of their preparation and uses thereof.

公开(公告)号：US20170020893A1

公开(公告)日：2017-01-26

申请号：US15139251

申请日：2016-04-26

申请人： Lipocine Inc.

发明人： Satish Kuma Nachaegari ,  Chandrashekar Giliyar ,  Raj Patel ,  Nachiappan Chidambaram ,  Srinivasan Venkateshwaran ,  Mahesh V. Patel

IPC分类号： A61K31/568 ,  A61K45/06

CPC分类号： A61K31/568 ,  A61K9/2013 ,  A61K9/4858 ,  A61K45/06

摘要： The present disclosure is drawn to oral pharmaceutical compositions and dosage forms containing select lipobalanced testosterone prodrugs and related methods. In one embodiment of the present invention, an oral pharmaceutical composition for administration to subjects in need of testosterone is provided. The composition comprises a lipobalanced testosterone prodrugs and a pharmaceutically acceptable carrier.

摘要翻译： 本公开涉及含有选择性脂质体睾酮前药的口服药物组合物和剂型及相关方法。 在本发明的一个实施方案中，提供了用于给予需要睾酮的受试者的口服药物组合物。 该组合物包含脂质体睾酮前药和药学上可接受的载体。

公开(公告)号：US20160213686A1

公开(公告)日：2016-07-28

申请号：US15090800

申请日：2016-04-05

申请人： LIPOCINE INC.

发明人： Chandrashekar Giliyar ,  Srinivasan Venkateshwaran ,  Basawaraj Chickmath ,  Satish Kumar Nachaegari ,  Nachiappan Chidambaram ,  Mahesh V. Patel

IPC分类号： A61K31/57 ,  A61K9/20 ,  A61K9/48 ,  A61K9/00 ,  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。

公开(公告)号：US09399069B2

公开(公告)日：2016-07-26

申请号：US14633545

申请日：2015-02-27

申请人： Lipocine Inc.

发明人： Chandrashekar Giliyar ,  Srinivasan Venkateshwaran ,  Basawaraj Chickmath ,  Satish Kumar Nachaegari ,  Nachiappan Chidambaram ,  Mahesh V. Patel

IPC分类号： A61K31/56 ,  A61K47/44 ,  A61K9/48 ,  A61K31/57 ,  A61K9/20 ,  A61K9/14 ,  A61K9/16 ,  A61K8/63 ,  A61Q11/00 ,  A61K47/10 ,  A61K47/12 ,  A61K47/14 ,  A61K47/20 ,  A61K47/22 ,  A61K47/26 ,  A61K47/32

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。

公开(公告)号：US20140271882A1

公开(公告)日：2014-09-18

申请号：US14261057

申请日：2014-04-24

申请人： Lipocine Inc.

发明人： Chandrashekar Giliyar ,  Srinivasan Venkateshwaran ,  Basawaraj Chickmath ,  Satish Kumar Nachaegari ,  Chidambaram Nachiappan ,  Mahesh V Patel

IPC分类号： A61K31/57

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.

公开(公告)号：US11590147B2

公开(公告)日：2023-02-28

申请号：US16927891

申请日：2020-07-13

申请人： Lipocine Inc.

发明人： Chandrashekar Giliyar ,  Srinivasan Venkateshwaran ,  Basawaraj Chickmath ,  Satish Nachaegari ,  Nachiappan Chidambaram ,  Mahesh V. Patel

IPC分类号： A61K31/57 ,  A61K9/20 ,  A61K9/00 ,  A61K9/14

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.

公开(公告)号：US11298365B2

公开(公告)日：2022-04-12

申请号：US16849957

申请日：2020-04-15

申请人： Lipocine Inc.

发明人： Mahesh V. Patel ,  Nachiappan Chidambaram ,  Satish Kumar Nachaegari ,  Srinivasan Venkateshwaran ,  Joel Frank

IPC分类号： A61K31/568 ,  A61K39/00 ,  A61K9/00 ,  A61K9/16

摘要： Disclosed are bioavailable solid state (17-β)-Hydroxy-4-Androsten-3-one esters suitable for pharmaceutical uses and administration to mammals in need of (17-β)-Hydroxy-4-Androsten-3-one.