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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
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.
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公开(公告)号：US11471470B2
公开(公告)日：2022-10-18
申请号：US16926506
申请日：2020-07-10
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： A61K31/57 , A61K9/48 , A61K9/00 , A61K9/14 , A61K9/16 , A61K9/20 , A61K8/63 , A61Q11/00 , A61K47/10 , A61K47/12 , A61K47/14 , A61K47/20 , A61K47/22 , A61K47/26 , A61K47/32 , A61K47/44
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.
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公开(公告)号：US11433083B2
公开(公告)日：2022-09-06
申请号：US16412360
申请日：2019-05-14
申请人： Lipocine Inc.
发明人： Chandrashekar Giliyar , Basawaraj Chickmath , Nachiappan Chidambaram , Mahesh V. Patel , Srinivansan Venkateshwaran
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.
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公开(公告)号：US20210106596A1
公开(公告)日：2021-04-15
申请号：US16926506
申请日：2020-07-10
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： A61K31/57 , A61K9/48 , A61K9/00 , A61K9/14 , A61K9/16 , A61K9/20 , A61K8/63 , A61Q11/00 , A61K47/10 , A61K47/12 , A61K47/14 , A61K47/20 , A61K47/22 , A61K47/26 , A61K47/32 , A61K47/44
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.
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公开(公告)号：US20190125760A1
公开(公告)日：2019-05-02
申请号：US15961691
申请日：2018-04-24
申请人： Lipocine Inc.
发明人： Chandrashekar Giliyar , Basawaraj Chickmath , Nachiappan Chidambaram , Mahesh V. Patel , Srinivansan Venkateshwaran
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.
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公开(公告)号：US20180228816A1
公开(公告)日：2018-08-16
申请号：US15955429
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
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.
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公开(公告)号：US09757390B2
公开(公告)日：2017-09-12
申请号：US15485154
申请日：2017-04-11
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
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.
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公开(公告)号：US20170216311A1
公开(公告)日：2017-08-03
申请号：US15485154
申请日：2017-04-11
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 , G01N33/74 , A61K9/00
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.
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公开(公告)号：US20160367569A1
公开(公告)日：2016-12-22
申请号：US14827137
申请日：2015-08-14
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 , A61K47/12
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％。
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公开(公告)号：US09358241B2
公开(公告)日：2016-06-07
申请号：US14298768
申请日：2014-06-06
申请人： Lipocine Inc.
发明人： Chandrashekar Giliyar , Srinivasan Venkateshwaran , Basawaraj Chickmath , Nachiappan Chidambaram , Mahesh V Patel
IPC分类号： A61K9/48 , A61P15/08 , A61K31/568 , A61K9/16
CPC分类号： A61K31/568 , A61K9/1664 , A61K9/4875
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.
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