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    High-strength testosterone undecanoate compositions
    5.
    发明授权
    High-strength testosterone undecanoate compositions 有权

    公开(公告)号：US11364250B2

    公开(公告)日：2022-06-21

    申请号：US16944008

    申请日：2020-07-30

    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 ,  A61K9/00 ,  A61K9/48 ,  A61K47/12 ,  A61K47/22 ,  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.

    Compositions and methods for treating central nervous system disorders
    6.
    发明授权
    Compositions and methods for treating central nervous system disorders 有权

    公开(公告)号：US11337987B1

    公开(公告)日：2022-05-24

    申请号：US17314883

    申请日：2021-05-07

    申请人： Lipocine Inc.

    发明人： Mahesh V. Patel ,  Nachiappan Chidambaram ,  Kilyoung Kim ,  Kongnara Papangkorn ,  Benjamin J. Bruno ,  Kiran Kumar Vangara

    IPC分类号： A61K31/57 ,  A61K9/00 ,  A61P25/24 ,  A61K9/48

    摘要： The present disclosure is drawn to compositions and methods for treating CNS disorders. In one embodiment, an oral pharmaceutical composition can comprise a therapeutically effective amount of pregn-4-ene-3,20-dione; and a pharmaceutically acceptable carrier that provides formation of either 3α-OH-5α-pregnan-20-one, or 3α-OH-5β-pregnan-20-one, or both in an amount sufficient to treat a CNS disorder when orally administered to a subject. In another embodiment, a method of treating a CNS disorder can comprise orally administering to a subject, a therapeutically effective amount of pregn-4-ene-3,20-dione that provides an amount of GABA receptor binding pregn-4-ene-3,20-dione metabolites that is sufficient to treat the CNS disorder. In another embodiment, a method of treating a CNS disorder can comprise orally administering to the subject, a therapeutically effective amount of pregn-4-ene-3,20-dione that provides an amount of 3α-OH-5α-pregnan-20-one, or 3α-OH-5β-pregnan-20-one, or both that is sufficient to treat the CNS disorder.

    17-HYDROXYPROGESTERONE ESTER-CONTAINING ORAL COMPOSITIONS AND RELATED METHODS
    7.
    发明申请
    17-HYDROXYPROGESTERONE ESTER-CONTAINING ORAL COMPOSITIONS AND RELATED METHODS 有权

    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.

    HIGH-STRENGTH TESTOSTERONE UNDECANOATE COMPOSITIONS
    9.
    发明申请
    HIGH-STRENGTH TESTOSTERONE UNDECANOATE COMPOSITIONS 有权

    公开(公告)号：US20210052604A1

    公开(公告)日：2021-02-25

    申请号：US16843837

    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 ,  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.

    Solid Carriers for Improved Delivery of Active Ingredients in Pharmaceutical Compositions
    10.
    发明申请
    Solid Carriers for Improved Delivery of Active Ingredients in Pharmaceutical Compositions 有权

    公开(公告)号：US20210008212A1

    公开(公告)日：2021-01-14

    申请号：US16917731

    申请日：2020-06-30

    申请人： Lipocine Inc.

    发明人： Mahesh V. Patel

    IPC分类号： A61K47/14 ,  A61K9/16 ,  A61K9/48 ,  A61K9/50 ,  B82Y5/00 ,  A61K31/352 ,  A61K31/4709 ,  A61K31/496 ,  A61K31/5383 ,  A61K31/5513 ,  A61K31/568 ,  A61K31/7048 ,  A61K47/10

    摘要： The present invention provides solid pharmaceutical compositions for improved delivery of a wide variety of pharmaceutical active ingredients contained therein or separately administered. In one embodiment, the solid pharmaceutical composition includes a solid carrier, the solid carrier including a substrate and an encapsulation coat on the substrate. The encapsulation coat can include different combinations of pharmaceutical active ingredients, hydrophilic surfactant, lipophilic surfactants and triglycerides. In another embodiment, the solid pharmaceutical composition includes a solid carrier, the solid carrier being formed of different combinations of pharmaceutical active ingredients, hydrophilic surfactants, lipophilic surfactants and triglycerides. The compositions of the present invention can be used for improved delivery of hydrophilic or hydrophobic pharmaceutical active ingredients, such as drugs, nutritional agents, cosmeceuticals and diagnostic agents.