Patents Assigned to Lipocine, Inc.
  • Publication number: 20200155570
    Abstract: 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.
    Type: Application
    Filed: July 19, 2019
    Publication date: May 21, 2020
    Applicant: Lipocine Inc.
    Inventors: Mahesh V. Patel, Nachiappan Chidambaram, Satish K. Nachaegari, Burke Byrne, Kilyoung Kim, Jonathan A. Baker
  • Publication number: 20200155575
    Abstract: Disclosed herein are compositions having a lipophilic active agent and methods of their use.
    Type: Application
    Filed: October 7, 2019
    Publication date: May 21, 2020
    Applicant: Lipocine Inc.
    Inventors: Mahesh Patel, Nachiappan Chidambaram, Satish Nachaegari, Srinivasan Venkateshwaran, Joel Frank, Chandrashekar Giliyar
  • Patent number: 10653706
    Abstract: 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.
    Type: Grant
    Filed: April 17, 2018
    Date of Patent: May 19, 2020
    Assignee: Lipocine Inc.
    Inventors: Chandrashekar Giliyar, Basawaraj Chickmath, Nachiappan Chidambaram, Mahesh V. Patel, Srinivansan Venkateshwaran
  • Publication number: 20200069701
    Abstract: 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.
    Type: Application
    Filed: November 8, 2019
    Publication date: March 5, 2020
    Applicant: Lipocine Inc.
    Inventors: Chandrashekar Giliyar, Basawaraj Chickmath, Nachiappan Chidambaram, Mahesh V. Patel, Srinivansan Venkateshwaran
  • Publication number: 20200069805
    Abstract: 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.
    Type: Application
    Filed: June 14, 2019
    Publication date: March 5, 2020
    Applicant: Lipocine Inc.
    Inventors: David T. Fikstad, Chandrashekar Giliyar, Srinivasan Venkateshwaran, Mahesh V. Patel
  • Publication number: 20200061191
    Abstract: 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.
    Type: Application
    Filed: February 28, 2019
    Publication date: February 27, 2020
    Applicant: Lipocine Inc.
    Inventor: Mahesh V. Patel
  • Patent number: 10561615
    Abstract: 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.
    Type: Grant
    Filed: September 29, 2014
    Date of Patent: February 18, 2020
    Assignee: Lipocine Inc.
    Inventors: Basawaraj Chickmath, Chandrashekar Giliyar, Nachiappan Chidambaram, Mahesh Patel, Srinivasan Venkateshwaran
  • Publication number: 20200046731
    Abstract: Disclosed are bioavailable solid state (17-?)-Hydroxy-4-Androsten-3-one esters suitable for pharmaceutical uses and administration to mammals in need of (17-?)-Hydroxy-4-Androsten-3-one.
    Type: Application
    Filed: February 12, 2019
    Publication date: February 13, 2020
    Applicant: Lipocine Inc.
    Inventors: Mahesh V. Patel, Nachiappan Chidambaram, Satish Kumar Nachaegari, Srinivasan Venkateshwaran, Joel Frank
  • Publication number: 20200022991
    Abstract: 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.
    Type: Application
    Filed: August 28, 2019
    Publication date: January 23, 2020
    Applicant: Lipocine Inc.
    Inventors: Mahesh V. Patel, Nachiappan Chidambaram, Satish K. Nachaegari, Burke Byrne, Kilyoung Kim, Jonathan A. Baker
  • Publication number: 20190388434
    Abstract: Disclosed herein are compositions having a lipophilic active agent and methods of their use.
    Type: Application
    Filed: May 30, 2019
    Publication date: December 26, 2019
    Applicant: Lipocine Inc.
    Inventors: Mahesh V. Patel, Nachiappan Chidambaram, Satish Kumar Nachaegari, Srinivansan Venkateshwaran, Joel Frank, Amy Jo Portlock
  • Publication number: 20190381067
    Abstract: 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.
    Type: Application
    Filed: January 7, 2019
    Publication date: December 19, 2019
    Applicant: Lipocine Inc.
    Inventors: Chandrashekar Giliyar, Basawaraj Chickmath, Nachiappan Chidambaram, Mahesh V. Patel, Srinivansan Venkateshwaran
  • Publication number: 20190365780
    Abstract: 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.
    Type: Application
    Filed: May 14, 2019
    Publication date: December 5, 2019
    Applicant: Lipocine Inc.
    Inventors: Chandrashekar Giliyar, Basawaraj Chickmath, Nachiappan Chidambaram, Mahesh V. Patel, Srinivansan Venkateshwaran
  • Publication number: 20190350943
    Abstract: Described here are substantially pure (17-?)-3-Oxoandrost-4-en-17-yl tridecanoate compositions, methods of their preparation and uses thereof.
    Type: Application
    Filed: March 27, 2019
    Publication date: November 21, 2019
    Applicant: Lipocine Inc.
    Inventors: Mahesh V. Patel, Nachiappan Chidambaram, Satish Kumar Nachaegari, Srinivasan Venkateshwaran, Joel Frank, Amy Jo Portlock
  • Publication number: 20190350942
    Abstract: Described herein are oral pharmaceutical compositions and their use in testosterone replacement therapy applications.
    Type: Application
    Filed: March 27, 2019
    Publication date: November 21, 2019
    Applicant: Lipocine Inc.
    Inventors: Mahesh V. Patel, Nachiappan Chidambaram, Satish Nachaegari, Srinivasan Venkateshwaran
  • Publication number: 20190321374
    Abstract: This application relates to methods and compositions useful for improving quality of life, sexual domain function or a combination thereof.
    Type: Application
    Filed: November 19, 2018
    Publication date: October 24, 2019
    Applicant: Lipocine Inc.
    Inventors: Mahesh V. Patel, Nachiappan Chidambaram, Satish Nachaegari
  • Publication number: 20190307775
    Abstract: 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.
    Type: Application
    Filed: March 28, 2019
    Publication date: October 10, 2019
    Applicant: Lipocine Inc.
    Inventors: Chandrashekar Giliyar, Srinivansan Venkateshwaran, Basawaraj Chickmath, Satish Kumar Nachaegari, Nachiappan Chidambaram, Mahesh V. Patel
  • Publication number: 20190275060
    Abstract: 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.
    Type: Application
    Filed: August 6, 2018
    Publication date: September 12, 2019
    Applicant: Lipocine Inc.
    Inventors: Chandrashekar Giliyar, Srinivasan Venkateshwaran, Basawaraj Chickmath, Satish Nachaegari, Nachiappan Chidambaram, Mahesh Patel
  • Publication number: 20190269700
    Abstract: Disclosed herein are compositions having a lipophilic active agent and methods of their use.
    Type: Application
    Filed: August 27, 2018
    Publication date: September 5, 2019
    Applicant: Lipocine Inc.
    Inventors: Mahesh Patel, Nachiappan Chidambaram, Satish Nachaegari, Srinivasan Venkateshwaran, Joel Frank, Chandrashekar Giliyar
  • Publication number: 20190240236
    Abstract: The present disclosure provides methods and compositions for testosterone replacement therapy. 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 testosterone ester while avoiding unacceptably high testosterone levels.
    Type: Application
    Filed: November 5, 2018
    Publication date: August 8, 2019
    Applicant: Lipocine Inc.
    Inventors: Nachiappan Chidambaram, Satish Kumar Nachaegari, Mahesh V. Patel, Kilyoung Kim
  • Publication number: 20190240235
    Abstract: The present disclosure is drawn to oral pharmaceutical compositions and dosage forms containing select lipobalanced testosterone prodrugs and related methods. In one embodiment of the present invention, an oral pharmaceutical composition for administration to subjects in need of testosterone is provided. The composition comprises a lipobalanced testosterone prodrugs and a pharmaceutically acceptable carrier.
    Type: Application
    Filed: November 5, 2018
    Publication date: August 8, 2019
    Applicant: Lipocine Inc.
    Inventors: Satish Kuma Nachaegari, Chandrashekar Giliyar, Raj Patel, Nachiappan Chidambaram, Srinivasan Venkateshwaran, Mahesh V. Patel