公开(公告)号：US09358299B2

公开(公告)日：2016-06-07

申请号：US14801737

申请日：2015-07-16

申请人： Lipocine Inc.

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

IPC分类号： A61K31/56 ,  A61K47/44 ,  A61K9/48 ,  A61K9/00 ,  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.

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：US10973833B2

公开(公告)日：2021-04-13

申请号：US16241712

申请日：2019-01-07

申请人： Lipocine Inc.

发明人： Chandrashekar Giliyar ,  Basawaraj Chickmath ,  Nachiappan Chidambaram ,  Mahesh V. Patel ,  Srinivansan Venkateshwaran

IPC分类号： A61K31/568 ,  A61K9/48 ,  A61K9/00 ,  A61K47/12 ,  G01N33/74 ,  A61K47/22 ,  A61K47/44

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.

公开(公告)号：US10881671B2

公开(公告)日：2021-01-05

申请号：US16843721

申请日：2020-04-08

申请人： Lipocine Inc.

发明人： Chandrashekar Giliyar ,  Basawaraj Chickmath ,  Nachiappan Chidambaram ,  Mahesh V. Patel ,  Srinivansan Venkateshwaran

IPC分类号： A61K31/568 ,  A61K9/48 ,  A61K9/00 ,  A61K47/12 ,  G01N33/74 ,  A61K47/22 ,  A61K47/44

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.

公开(公告)号：US10799513B2

公开(公告)日：2020-10-13

申请号：US15955374

申请日：2018-04-17

申请人： Lipocine Inc.

发明人： Chandrashekar Giliyar ,  Basawaraj Chickmath ,  Nachiappan Chidambaram ,  Mahesh V. Patel ,  Srinivansan Venkateshwaran

IPC分类号： A61K9/48 ,  A61K31/568 ,  A61P15/08 ,  A61K9/00 ,  G01N33/74 ,  A61K47/12 ,  A61K47/22 ,  A61K47/44

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.

公开(公告)号：US20200069701A1

公开(公告)日：2020-03-05

申请号：US16679033

申请日：2019-11-08

申请人： Lipocine Inc.

发明人： Chandrashekar Giliyar ,  Basawaraj Chickmath ,  Nachiappan Chidambaram ,  Mahesh V. Patel ,  Srinivansan Venkateshwaran

IPC分类号： A61K31/568 ,  A61K47/44 ,  A61K47/22 ,  A61K47/12 ,  G01N33/74 ,  A61K9/00 ,  A61K9/48

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.

公开(公告)号：US20180353519A1

公开(公告)日：2018-12-13

申请号：US15955374

申请日：2018-04-17

申请人： Lipocine Inc.

发明人： Chandrashekar Giliyar ,  Basawaraj Chickmath ,  Nachiappan Chidambaram ,  Mahesh V. Patel ,  Srinivansan Venkateshwaran

IPC分类号： A61K31/568 ,  A61K9/48 ,  A61K9/00 ,  A61K47/22 ,  A61K47/12 ,  G01N33/74 ,  A61K47/44

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.

公开(公告)号：US20180125857A1

公开(公告)日：2018-05-10

申请号：US15670705

申请日：2017-08-07

申请人： Lipocine Inc.

发明人： Chandrashekar Giliyar ,  Basawaraj Chickmath ,  Nachiappan Chidambaram ,  Mahesh V. Patel ,  Srinivansan Venkateshwaran

IPC分类号： A61K31/568 ,  G01N33/74 ,  A61K47/44 ,  A61K47/22 ,  A61K9/00 ,  A61K9/48 ,  A61K47/12

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.

公开(公告)号：US09949985B2

公开(公告)日：2018-04-24

申请号：US15818697

申请日：2017-11-20

申请人： Lipocine Inc.

发明人： Chandrashekar Giliyar ,  Basawaraj Chickmath ,  Nachiappan Chidambaram ,  Mahesh V. Patel ,  Srinivansan Venkateshwaran

IPC分类号： A61K9/48 ,  A61K31/568 ,  A61K9/00 ,  A61P15/08 ,  G01N33/74 ,  A61K47/44 ,  A61K47/22 ,  A61K47/12

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.

公开(公告)号：US20170035781A1

公开(公告)日：2017-02-09

申请号：US15190109

申请日：2016-06-22

申请人： Lipocine Inc.

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

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

CPC分类号： A61K31/57 ,  A61K9/0053 ,  A61K9/14 ,  A61K9/2086

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.