Patents Assigned to Lipocine, Inc.
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Publication number: 20200061191Abstract: 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: ApplicationFiled: February 28, 2019Publication date: February 27, 2020Applicant: Lipocine Inc.Inventor: Mahesh V. Patel
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Patent number: 10561615Abstract: 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: GrantFiled: September 29, 2014Date of Patent: February 18, 2020Assignee: Lipocine Inc.Inventors: Basawaraj Chickmath, Chandrashekar Giliyar, Nachiappan Chidambaram, Mahesh Patel, Srinivasan Venkateshwaran
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Publication number: 20200046731Abstract: 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: ApplicationFiled: February 12, 2019Publication date: February 13, 2020Applicant: Lipocine Inc.Inventors: Mahesh V. Patel, Nachiappan Chidambaram, Satish Kumar Nachaegari, Srinivasan Venkateshwaran, Joel Frank
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Publication number: 20200022991Abstract: 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: ApplicationFiled: August 28, 2019Publication date: January 23, 2020Applicant: Lipocine Inc.Inventors: Mahesh V. Patel, Nachiappan Chidambaram, Satish K. Nachaegari, Burke Byrne, Kilyoung Kim, Jonathan A. Baker
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Publication number: 20190388434Abstract: Disclosed herein are compositions having a lipophilic active agent and methods of their use.Type: ApplicationFiled: May 30, 2019Publication date: December 26, 2019Applicant: Lipocine Inc.Inventors: Mahesh V. Patel, Nachiappan Chidambaram, Satish Kumar Nachaegari, Srinivansan Venkateshwaran, Joel Frank, Amy Jo Portlock
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Publication number: 20190381067Abstract: 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: ApplicationFiled: January 7, 2019Publication date: December 19, 2019Applicant: Lipocine Inc.Inventors: Chandrashekar Giliyar, Basawaraj Chickmath, Nachiappan Chidambaram, Mahesh V. Patel, Srinivansan Venkateshwaran
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Publication number: 20190365780Abstract: 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: ApplicationFiled: May 14, 2019Publication date: December 5, 2019Applicant: Lipocine Inc.Inventors: Chandrashekar Giliyar, Basawaraj Chickmath, Nachiappan Chidambaram, Mahesh V. Patel, Srinivansan Venkateshwaran
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Publication number: 20190350943Abstract: Described here are substantially pure (17-?)-3-Oxoandrost-4-en-17-yl tridecanoate compositions, methods of their preparation and uses thereof.Type: ApplicationFiled: March 27, 2019Publication date: November 21, 2019Applicant: Lipocine Inc.Inventors: Mahesh V. Patel, Nachiappan Chidambaram, Satish Kumar Nachaegari, Srinivasan Venkateshwaran, Joel Frank, Amy Jo Portlock
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Publication number: 20190350942Abstract: Described herein are oral pharmaceutical compositions and their use in testosterone replacement therapy applications.Type: ApplicationFiled: March 27, 2019Publication date: November 21, 2019Applicant: Lipocine Inc.Inventors: Mahesh V. Patel, Nachiappan Chidambaram, Satish Nachaegari, Srinivasan Venkateshwaran
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Publication number: 20190321374Abstract: This application relates to methods and compositions useful for improving quality of life, sexual domain function or a combination thereof.Type: ApplicationFiled: November 19, 2018Publication date: October 24, 2019Applicant: Lipocine Inc.Inventors: Mahesh V. Patel, Nachiappan Chidambaram, Satish Nachaegari
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Publication number: 20190307775Abstract: 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: ApplicationFiled: March 28, 2019Publication date: October 10, 2019Applicant: Lipocine Inc.Inventors: Chandrashekar Giliyar, Srinivansan Venkateshwaran, Basawaraj Chickmath, Satish Kumar Nachaegari, Nachiappan Chidambaram, Mahesh V. Patel
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Publication number: 20190275060Abstract: 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: ApplicationFiled: August 6, 2018Publication date: September 12, 2019Applicant: Lipocine Inc.Inventors: Chandrashekar Giliyar, Srinivasan Venkateshwaran, Basawaraj Chickmath, Satish Nachaegari, Nachiappan Chidambaram, Mahesh Patel
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Publication number: 20190269700Abstract: Disclosed herein are compositions having a lipophilic active agent and methods of their use.Type: ApplicationFiled: August 27, 2018Publication date: September 5, 2019Applicant: Lipocine Inc.Inventors: Mahesh Patel, Nachiappan Chidambaram, Satish Nachaegari, Srinivasan Venkateshwaran, Joel Frank, Chandrashekar Giliyar
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Publication number: 20190240236Abstract: 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: ApplicationFiled: November 5, 2018Publication date: August 8, 2019Applicant: Lipocine Inc.Inventors: Nachiappan Chidambaram, Satish Kumar Nachaegari, Mahesh V. Patel, Kilyoung Kim
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Publication number: 20190240235Abstract: 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: ApplicationFiled: November 5, 2018Publication date: August 8, 2019Applicant: Lipocine Inc.Inventors: Satish Kuma Nachaegari, Chandrashekar Giliyar, Raj Patel, Nachiappan Chidambaram, Srinivasan Venkateshwaran, Mahesh V. Patel
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Publication number: 20190175615Abstract: The present disclosure is drawn to oral pharmaceutical compositions and dosage forms containing select testosterone esters 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 testosterone ester and a pharmaceutically acceptable carrier. The testosterone ester can have the structure wherein R is —C13H25O or —C14H27O. One or both of the esters can be present in the pharmaceutical composition. The composition is formulated such that upon single dose administration to a group of human subject, the composition provides a mean serum testosterone Cavg t12-t24 that is within about 35% to about 70% of the mean serum testosterone Cavg t0-t24.Type: ApplicationFiled: July 6, 2018Publication date: June 13, 2019Applicant: Lipocine Inc.Inventors: Satish Kumar Nachaegari, Chandrashekar Giliyar, Raj Patel, Nachiappan Chidambaram, Srinivansan Venkateshwaran, Mahesh V. Patel
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Publication number: 20190125760Abstract: 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: ApplicationFiled: April 24, 2018Publication date: May 2, 2019Applicant: Lipocine Inc.Inventors: Chandrashekar Giliyar, Basawaraj Chickmath, Nachiappan Chidambaram, Mahesh V. Patel, Srinivansan Venkateshwaran
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Patent number: 10226473Abstract: 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: GrantFiled: April 17, 2018Date of Patent: March 12, 2019Assignee: Lipocine Inc.Inventors: Chandrashekar Giliyar, Basawaraj Chickmath, Nachiappan Chidambaram, Mahesh V. Patel, Srinivansan Venkateshwaran
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Publication number: 20180353519Abstract: 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: ApplicationFiled: April 17, 2018Publication date: December 13, 2018Applicant: Lipocine Inc.Inventors: Chandrashekar Giliyar, Basawaraj Chickmath, Nachiappan Chidambaram, Mahesh V. Patel, Srinivansan Venkateshwaran
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Publication number: 20180333422Abstract: 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: ApplicationFiled: November 28, 2017Publication date: November 22, 2018Applicant: Lipocine Inc.Inventors: Nachiappan Chidambaram, Satish Kumar Nachaegari, Mahesh V. Patel, Kilyoung Kim