公开(公告)号：US20230390304A1

公开(公告)日：2023-12-07

申请号：US18328388

申请日：2023-06-02

申请人： Lipocine Inc.

发明人： Benjamin J. Bruno ,  Nachiappan Chidambaram ,  Jonathan Ogle ,  Kongnara Papangkorn ,  Mahesh V. Patel

IPC分类号： A61K31/57 ,  A61K9/00

CPC分类号： A61K31/57 ,  A61K9/0053

摘要： Disclosed is a method and composition for treating CNS disorders in a subject. In an embodiment, the method preferably comprises the ordered steps of identifying a subject having or being predisposed to epilepsy, and orally administering to the subject an AED. The administration preferably comprises an administration regimen of a predetermined quantity of the AED, at a predetermined frequency, and for a predetermined duration. The subject preferably comprises a subject experiencing seizure clusters, WWE, and more especially a WWE of childbearing age. The composition preferably comprises a NAS, and more especially an ENAS. The method preferably results in the prevention, or reduced frequency or magnitude of epileptic seizures.

公开(公告)号：US20230321116A1

公开(公告)日：2023-10-12

申请号：US17706210

申请日：2022-03-28

申请人： Lipocine Inc.

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

IPC分类号： A61K31/57

CPC分类号： A61K31/57

摘要： Disclosed are methods and oral compositions for treating CNS disorders. An embodiment of the invention comprises orally administering a 3α-OH-5β-pregnan-20-one containing composition to a subject having a CNS disorder. The composition preferably exhibits a fast release rate of the 3α-OH-5β-pregnan-20-one. The current compositions may provide desired serum levels of 3α-OH-5β-pregnan-20-one to effectively treat CNS disorders. The oral compositions and methods disclosed herein may be administered to a subject in need of CNS disorder therapy, to deliver therapeutically effective amounts of 3α-OH-5β-pregnan-20-one for treating CNS disorders.

公开(公告)号：US11364249B2

公开(公告)日：2022-06-21

申请号：US16843810

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 ,  A61K9/00 ,  A61K9/48 ,  A61K47/12 ,  A61K47/22 ,  G01N33/74 ,  A61P15/08 ,  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：US11311555B2

公开(公告)日：2022-04-26

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 ,  A61K9/00 ,  A61K9/48 ,  A61K47/12 ,  A61K47/22 ,  A61K47/44 ,  G01N33/74

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：US20210177865A1

公开(公告)日：2021-06-17

申请号：US17183506

申请日：2021-02-24

申请人： Lipocine Inc.

发明人： Chandrashekar Giliyar ,  Nachiappan Chidambaram ,  Mahesh V. Patel ,  Srinivasan Venkateshwaran

IPC分类号： A61K31/569 ,  A61K9/48 ,  A61K31/568 ,  A61K9/00 ,  A61K47/10 ,  A61K47/14 ,  A61K47/44

摘要： Provided herein are steroid containing compositions suitable for providing therapeutically effective amounts of at least one steroid to individuals. Also provided herein are compositions comprising testosterone and/or testosterone derivatives suitable for providing therapeutically effective and safe amounts of testosterone over periods of time. Further provided are methods of treating andro- and/or testosterone deficiency in individuals by administering to the individuals compositions described herein.

公开(公告)号：US10716794B2

公开(公告)日：2020-07-21

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

IPC分类号： A61K9/48 ,  A61K31/568 ,  A61K9/00 ,  A61P15/08 ,  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：US10709716B2

公开(公告)日：2020-07-14

申请号：US16368431

申请日：2019-03-28

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 ,  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.

公开(公告)号：US20200069805A1

公开(公告)日：2020-03-05

申请号：US16442294

申请日：2019-06-14

申请人： Lipocine Inc.

发明人： David T. Fikstad ,  Chandrashekar Giliyar ,  Srinivasan Venkateshwaran ,  Mahesh V. Patel

IPC分类号： A61K47/44 ,  A61K31/568 ,  A61K31/4709 ,  A61K31/404 ,  A61K31/403 ,  A61K9/00 ,  A61K47/40 ,  A61K47/34 ,  A61K47/26 ,  A61K47/22 ,  A61K47/14 ,  A61K47/12 ,  A61K47/10 ,  A61K31/724 ,  A61K31/66 ,  A61K31/401 ,  A61K31/366 ,  A61K31/355 ,  A61K31/35 ,  A61K31/34 ,  A61K31/28 ,  A61K31/265 ,  A61K31/225 ,  A61K31/17 ,  A61K9/48 ,  A61K9/20 ,  A61K9/16

摘要： Pharmaceutical compositions with synchronized solubilizer release as well as various methods associated therewith, are disclosed and described. More specifically, the aqueous solubility of a drug is enhanced by synchronized release of a solubilizer.

公开(公告)号：US10561615B2

公开(公告)日：2020-02-18

申请号：US14500498

申请日：2014-09-29

申请人： Lipocine Inc.

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

IPC分类号： A61K9/20 ,  A61K31/568 ,  A61K47/10 ,  A61K47/36 ,  A61K9/14 ,  A61K9/16 ,  A61K9/28 ,  A61K9/48 ,  A61K47/40 ,  A61K47/38

摘要： The present disclosure is drawn to pharmaceutical compositions and oral dosage forms containing testosterone undecanoate, as well as related methods of treatment. In one embodiment, the oral dosage form can include a therapeutically effective amount of testosterone undecanoate and a pharmaceutically acceptable carrier. The dosage form can be formulated such that, when measured using a USP Type II apparatus in 1000 mL of 8 wt % Triton X-100 in water at 37° C. and 100 rpm, the oral dosage form releases at least 20% more testosterone undecanoate after the first 120 minutes than an equivalent dose testosterone undecanoate containing oral dosage form without the pharmaceutically acceptable carrier.

公开(公告)号：US20190269700A1

公开(公告)日：2019-09-05

申请号：US16114135

申请日：2018-08-27

申请人： Lipocine Inc.

发明人： Mahesh Patel ,  Nachiappan Chidambaram ,  Satish Nachaegari ,  Srinivasan Venkateshwaran ,  Joel Frank ,  Chandrashekar Giliyar

IPC分类号： A61K31/575 ,  A61P15/08 ,  A61K9/48 ,  A61K31/568 ,  A61K47/44 ,  A61K9/00 ,  A61K47/12 ,  A61K47/10 ,  A61K47/14

摘要： Disclosed herein are compositions having a lipophilic active agent and methods of their use.