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公开(公告)号：US20200155570A1
公开(公告)日：2020-05-21
申请号：US16517533
申请日：2019-07-19
申请人： Lipocine Inc.
发明人： Mahesh V. Patel , Nachiappan Chidambaram , Satish K. Nachaegari , Burke Byrne , Kilyoung Kim , Jonathan A. Baker
IPC分类号： A61K31/568 , A61K31/355 , A61P1/16
摘要： Methods of treating a liver disease or condition, or a symptom thereof, in a subject in need of treatment, are disclosed and described. One method comprises orally administering to a subject, a pharmaceutical composition having an amount of a testosterone, or an ester thereof, sufficient to treat the liver disease or condition, or symptom thereof.
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公开(公告)号：US20240173334A1
公开(公告)日：2024-05-30
申请号：US18437438
申请日：2024-02-09
申请人： Lipocine Inc.
发明人： Kilyoung Kim , Mahesh V. Patel , Nachiappan Chidambaram , Satish K. Nachaegari , Burke Byrne , Jonathan A. Baker
IPC分类号： A61K31/568 , G01N33/74
CPC分类号： A61K31/568 , G01N33/743 , G01N2800/52
摘要： Disclosed are pharmaceutical compositions and oral dosage forms including capsules containing (17-ß)-3-oxoandrost-4-en-17-yl tridecanoate, and related methods. The capsule fill can include an additive and about 14 wt % to about 42 wt % for androst-4-en-17β-ol-3-one esters that comprise (17-ß)-3-oxoandrost-4-en-17-yl tridecanoate or a combination of (17-ß)-3-oxoandrost-4-en-17-yl undecanoate, (17-ß)-3-oxoandrost-4-en-17-yl dodecanoate, and (17-ß)-3-oxoandrost-4-en-17-yl tridecanoate. A single oral administration to a male subject of one or more dosage forms with a total androst-4-en-17β-ol-3-one equivalent dose of about 150 mg to about 895 mg is provided. In another embodiment, a method for providing a serum concentration of androst-4-en-17β-ol-3-one within a target PK performance for a male subject is provided. In a further embodiment, the pharmaceutical compositions and methods comprising androst-4-en-17β-ol-3-one ester loading of 14 wt % to 42 wt % achieve androst-4-en-17β-ol-3-one PK performance targets and require titration(s) to show therapeutic effectiveness for treatment of hypogonadism.
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公开(公告)号：US12097207B1
公开(公告)日：2024-09-24
申请号：US17547496
申请日：2021-12-10
申请人： Lipocine Inc.
发明人： Mahesh V. Patel , Nachiappan Chidambaram , Satish K. Nachaegari , Burke Byrne , Kilyoung Kim , Jonathan A. Baker
IPC分类号： A61K31/568 , A61K31/201 , A61K31/355 , A61P1/16 , G01N33/92 , A61K45/06
CPC分类号： A61K31/568 , A61K31/201 , A61K31/355 , A61P1/16 , G01N33/92 , A61K45/06 , G01N2800/085 , G01N2800/52
摘要： Methods of treating a liver disease or condition, or a symptom thereof, in a subject in need of treatment, are disclosed and described. One method comprises orally administering to a subject, a pharmaceutical composition having an amount of a testosterone, or an ester thereof, sufficient to treat the liver disease or condition, or symptom thereof.
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公开(公告)号：US11672807B1
公开(公告)日：2023-06-13
申请号：US17132167
申请日：2020-12-23
申请人： Lipocine Inc.
IPC分类号： A61K31/568 , A61K9/00 , A61K9/48 , A61P5/24
CPC分类号： A61K31/568 , A61K9/0053 , A61K9/48 , A61P5/24 , A61K9/4858
摘要： Disclosed are methods and compositions for testosterone replacement therapy, especially for use in administration to hypogonadal males. The methods and compositions employ a fixed dose dosing regimen that does not require titration or dose adjustments and that can provide a therapeutically effective amount of a non-undecanoate testosterone ester while avoiding unacceptably high testosterone levels.
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公开(公告)号：US20200022991A1
公开(公告)日：2020-01-23
申请号：US16554444
申请日：2019-08-28
申请人： Lipocine Inc.
发明人： Mahesh V. Patel , Nachiappan Chidambaram , Satish K. Nachaegari , Burke Byrne , Kilyoung Kim , Jonathan A. Baker
IPC分类号： A61K31/568 , G01N33/92 , A61P1/16 , A61K31/201 , A61K31/355
摘要： Methods of treating a liver disease or condition, or a symptom thereof, in a subject in need of treatment, are disclosed and described. One method comprises orally administering to a subject, a pharmaceutical composition having an amount of a testosterone, or an ester thereof, sufficient to treat the liver disease or condition, or symptom thereof.
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公开(公告)号：US20160361322A1
公开(公告)日：2016-12-15
申请号：US15183691
申请日：2016-06-15
申请人： Lipocine Inc.
CPC分类号： A61K31/568 , A61J1/035 , A61J1/06 , A61J1/10 , A61J7/0076 , A61K9/0053 , A61K9/4858 , A61K9/4866
摘要： Provided oral testosterone undecanoate compositions can be administered to hypogonadal males with a meal without the fat content of the meal substantially effecting bioavailability.
摘要翻译： 提供口服的十一酸睾丸酮组合物可以以不含基本上影响生物利用度的膳食的脂肪含量的膳食施用于性腺功能减退的男性。
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公开(公告)号：US11992496B1
公开(公告)日：2024-05-28
申请号：US18310784
申请日：2023-05-02
申请人： Lipocine Inc.
IPC分类号： A61K31/568 , A61K9/00 , A61K9/48 , A61P5/24
CPC分类号： A61K31/568 , A61K9/0053 , A61K9/48 , A61P5/24 , A61K9/4858
摘要： Disclosed are methods and compositions for testosterone replacement therapy, especially for use in administration to hypogonadal males. The methods and compositions employ an untitrated dose dosing regimen that does not require titration or dose adjustments and that can provide a therapeutically effective amount of a testosterone ester, such as a non-undecanoate testosterone ester, while avoiding unacceptably high testosterone levels.
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公开(公告)号：US20200222425A1
公开(公告)日：2020-07-16
申请号：US16726572
申请日：2019-12-24
申请人： Lipocine Inc.
摘要： Provided oral testosterone undecanoate compositions can be administered to hypogonadal males with a meal without the fat content of the meal substantially effecting bioavailability.
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公开(公告)号：US20180221387A1
公开(公告)日：2018-08-09
申请号：US15861492
申请日：2018-01-03
申请人： Lipocine Inc.
CPC分类号： A61K31/568 , A61J1/035 , A61J1/06 , A61J1/10 , A61J7/0076 , A61K9/0053 , A61K9/4858 , A61K9/4866
摘要： Provided oral testosterone undecanoate compositions can be administered to hypogonadal males with a meal without the fat content of the meal substantially effecting bioavailability.
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