Patents Assigned to Lipocine, Inc.
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Publication number: 20160193227Abstract: 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 t0-424.Type: ApplicationFiled: February 4, 2016Publication date: July 7, 2016Applicant: Lipocine Inc.Inventors: Satish Kumar Nachaegari, Chandrashekar Giliyar, Raj Patel, Nachiappan Chidambaram, Srinivansan Venkateshwaran, Mahesh V. Patel
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Publication number: 20160184435Abstract: Pharmaceutical compositions and dosage forms for administration of hydrophobic drugs are provided. The pharmaceutical compositions include a therapeutically effective amount of a hydrophobic drug, preferably a steroid; a solubilizer, and a surfactant. The synergistic effect between the hydrophobic drug and the solubilizer results in a pharmaceutical formulation with improved dispersion of both the active agent and the solubilizer. As a result of the improved dispersion, the pharmaceutical composition has improved bioavailability upon administration. Methods of improving the bioavailability of hydrophobic drugs administered to a patient are also provided.Type: ApplicationFiled: December 18, 2015Publication date: June 30, 2016Applicant: Lipocine Inc.Inventors: Feng-Jing Chen, Mahesh V. Patel, David T. Fikstad, Huiping Zhang, Chandrashekar Giliyar
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Publication number: 20160184321Abstract: Described herein are oral pharmaceutical compositions and their use in testosterone replacement therapy applications.Type: ApplicationFiled: September 24, 2015Publication date: June 30, 2016Applicant: Lipocine Inc.Inventors: Mahesh Patel, Nachiappan Chidambaram, Satish Nachaegari, Srinivasan Venkateshwaran
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Publication number: 20160184320Abstract: 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: August 28, 2015Publication date: June 30, 2016Applicant: Lipocine Inc.Inventors: Mahesh V. Patel, Nachiappan Chidambaram, Satish Kumar Nachaegari, Srinivasan Venkateshwaran, Joel Frank
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Publication number: 20160184324Abstract: Disclosed herein are compositions having a lipophilic active agent and methods of their use.Type: ApplicationFiled: August 28, 2015Publication date: June 30, 2016Applicant: LIPOCINE INC.Inventors: Mahesh Patel, Nachiappan Chidambaram, Satish Nachaegari, Srinivasan Venkateshwaran, Joel Frank, Chandrashekar Giliyar
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Patent number: 9375437Abstract: The present invention provides for progesterone containing pharmaceutical oral dosage forms, pharmaceutical kits, and related methods. In one embodiment, an oral dosage form formulated for on-going administration is provided. The oral dosage form includes an amount of progesterone and a pharmaceutically acceptable carrier. The oral dosage form is formulated such that upon single dose administration to a non-pregnant woman in follicular phase, the oral dosage form provides a serum progesterone C24h of at least 0.20 ng/mL.Type: GrantFiled: October 4, 2012Date of Patent: June 28, 2016Assignee: LIPOCINE INC.Inventors: Satish Kumar Nachaegari, Chandrashekar Giliyar, Chidambaram Nachiappan, Mahesh V. Patel, Srinivasan Venkateshwaran
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Publication number: 20160166584Abstract: Described herein are oral pharmaceutical compositions and their use in testosterone replacement therapy applications.Type: ApplicationFiled: January 22, 2016Publication date: June 16, 2016Applicant: Lipocine Inc.Inventors: Mahesh V. Patel, Nachiappan Chidambaram, Satish Nachaegari, Srinivasan Venkateshwaran
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Publication number: 20160166585Abstract: Described herein are oral pharmaceutical compositions and their use in testosterone replacement therapy applications.Type: ApplicationFiled: January 22, 2016Publication date: June 16, 2016Applicant: Lipocine Inc.Inventors: Mahesh V. Patel, Nachiappan Chidambaram, Satish Nachaegari, Srinivasan Venkateshwaran
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Patent number: 9364547Abstract: 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: GrantFiled: April 24, 2014Date of Patent: June 14, 2016Assignee: LIPOCINE INC.Inventors: Chandrashekar Giliyar, Srinivasan Venkateshwaran, Basawaraj Chickmath, Satish Kumar Nachaegari, Nachiappan Chidambaram, Mahesh V. Patel
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Patent number: 9358241Abstract: 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: June 6, 2014Date of Patent: June 7, 2016Assignee: LIPOCINE INC.Inventors: Chandrashekar Giliyar, Srinivasan Venkateshwaran, Basawaraj Chickmath, Nachiappan Chidambaram, Mahesh V Patel
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Patent number: 9358298Abstract: 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: GrantFiled: September 4, 2014Date of Patent: June 7, 2016Assignee: LIPOCINE INC.Inventors: Chandrashekar Giliyar, Srinivasan Venkateshwaran, Basawaraj Chickmath, Satish Kumar Nachaegari, Nachiappan Chidambaram, Mahesh V. Patel
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Patent number: 9358299Abstract: 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: GrantFiled: July 16, 2015Date of Patent: June 7, 2016Assignee: LIPOCINE INCInventors: Chandrashekar Giliyar, Srinivansan Venkateshwaran, Basawaraj Chickmath, Satish Kumar Nachaegari, Nachiappan Chidambaram, Mahesh V. Patel
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Publication number: 20160074416Abstract: 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: November 25, 2015Publication date: March 17, 2016Applicant: Lipocine Inc.Inventors: Chandrashekar Giliyar, Basawaraj Chickmath, Chidambaram Nachiappan, Mahesh V. Patel, Srinivansan Venkateshwaran
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Patent number: 9205057Abstract: 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 20, 2015Date of Patent: December 8, 2015Assignee: Lipocine Inc.Inventors: Chandrashekar Giliyar, Basawaraj Chickmath, Chidambaram Nachiappan, Mahesh V. Patel, Srinivansan Venkateshwaran
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Publication number: 20150320768Abstract: 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: July 16, 2015Publication date: November 12, 2015Applicant: LIPOCINE INC.Inventors: Chandrashekar Giliyar, Srinivansan Venkateshwaran, Basawaraj Chickmath, Satish Kumar Nachaegari, Chidambaram Nachiappan, Mahesh V. Patel
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Publication number: 20150320765Abstract: 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: July 16, 2015Publication date: November 12, 2015Applicant: Lipocine Inc.Inventors: Chandrashekar Giliyar, Basawaraj Chickmath, Chidambaram Nachiappan, Mahesh V. Patel, Srinivansan Venkateshwaran
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Publication number: 20150273067Abstract: 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: May 15, 2015Publication date: October 1, 2015Applicant: Lipocine Inc.Inventor: Mahesh V. Patel
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Patent number: 9034858Abstract: 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: May 31, 2012Date of Patent: May 19, 2015Assignee: Lipocine Inc.Inventors: Chandrashekar Giliyar, Basawaraj Chickmath, Chidambaram Nachiappan, Mahesh V. Patel, Srinivansan Venkateshwaran
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Patent number: 8951996Abstract: 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: GrantFiled: July 28, 2011Date of Patent: February 10, 2015Assignee: Lipocine Inc.Inventors: Chandrashekar Giliyar, Srinivasan Venkateshwaran, Basawaraj Chickmath, Satish Kumar Nachaegari, Chidambaram Nachiappan, Mahesh V. Patel
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Patent number: 8865695Abstract: 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.Type: GrantFiled: February 26, 2014Date of Patent: October 21, 2014Assignee: Lipocine Inc.Inventors: Chandrashekar Giliyar, Nachiappan Chidambaram, Mahesh V. Patel, Srinivasan Venkateshwaran