Patents Assigned to Lipocine, Inc.
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Publication number: 20180071312Abstract: 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 20, 2017Publication date: March 15, 2018Applicant: Lipocine Inc.Inventors: Chandrashekar Giliyar, Basawaraj Chickmath, Nachiappan Chidambaram, Mahesh V. Patel, Srinivansan Venkateshwaran
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Publication number: 20180055854Abstract: 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 3, 2017Publication date: March 1, 2018Applicant: Lipocine Inc.Inventors: Chandrashekar Giliyar, Basawaraj Chickmath, Nachiappan Chidambaram, Mahesh V. Patel, Srinivansan Venkateshwaran
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Publication number: 20170354663Abstract: 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: ApplicationFiled: May 16, 2017Publication date: December 14, 2017Applicant: Lipocine Inc.Inventors: Chandrashekar Giliyar, Nachiappan Chidambaram, Mahesh V. Patel, Srinivasan Venkateshwaran
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Patent number: 9757390Abstract: 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 11, 2017Date of Patent: September 12, 2017Assignee: Lipocine Inc.Inventors: Chandrashekar Giliyar, Basawaraj Chickmath, Nachiappan Chidambaram, Mahesh V. Patel, Srinivansan Venkateshwaran
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Patent number: 9757389Abstract: 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: GrantFiled: September 26, 2016Date of Patent: September 12, 2017Assignee: Lipocine Inc.Inventors: Mahesh V. Patel, Nachiappan Chidambaram, Satish Kumar Nachaegari, Srinivasan Venkateshwaran, Joel Frank
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Publication number: 20170252357Abstract: 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: ApplicationFiled: May 16, 2017Publication date: September 7, 2017Applicant: Lipocine Inc.Inventors: Chandrashekar Giliyar, Nachiappan Chidambaram, Mahesh V. Patel, Srinivasan Venkateshwaran
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Publication number: 20170246186Abstract: 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 12, 2017Publication date: August 31, 2017Applicant: Lipocine Inc.Inventors: Chandrashekar Giliyar, Basawaraj Chickmath, Nachiappan Chidambaram, Mahesh V. Patel, Srinivansan Venkateshwaran
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Publication number: 20170246187Abstract: Described here are substantially pure (17-?)-3-Oxoandrost-4-en-17-yl tridecanoate compositions, methods of their preparation and uses thereof.Type: ApplicationFiled: August 28, 2015Publication date: August 31, 2017Applicant: Lipocine Inc.Inventors: Mahesh V. Patel, Nachiappan Chidambaram, Satish Kumar Nachaegari, Srinivasan Venkateshwaran, Joel Frank, Amy Jo Portlock
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Publication number: 20170216311Abstract: 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 11, 2017Publication date: August 3, 2017Applicant: Lipocine Inc.Inventors: Chandrashekar Giliyar, Basawaraj Chickmath, Nachiappan Chidambaram, Mahesh V. Patel, Srinivansan Venkateshwaran
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Publication number: 20170216312Abstract: 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: ApplicationFiled: April 20, 2017Publication date: August 3, 2017Applicant: Lipocine Inc.Inventors: Chandrashekar Giliyar, Nachiappan Chidambaram, Mahesh V. Patel, Srinivasan Venkateshwaran
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Publication number: 20170035781Abstract: 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: June 22, 2016Publication date: February 9, 2017Applicant: Lipocine Inc.Inventors: Chandrashekar Giliyar, Srinivasan Venkateshwaran, Basawaraj Chickmath, Satish Nachaegari, Nachiappan Chidambaram, Mahesh Patel
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Publication number: 20170020893Abstract: 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: April 26, 2016Publication date: January 26, 2017Applicant: Lipocine Inc.Inventors: Satish Kuma Nachaegari, Chandrashekar Giliyar, Raj Patel, Nachiappan Chidambaram, Srinivasan Venkateshwaran, Mahesh V. Patel
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Publication number: 20170007623Abstract: 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: September 15, 2016Publication date: January 12, 2017Applicant: Lipocine Inc.Inventors: Chandrashekar Giliyar, Srinivasan Venkateshwaran, Basawaraj Chickmath, Satish Kumar Nachaegari, Nachiappan Chidambaram, Mahesh V. Patel
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Publication number: 20160367569Abstract: The present disclosure is drawn to pharmaceutical compositions and oral dosage capsules containing testosterone undecanoate, as well as related methods of treatment. In one embodiment, the present invention provides for a pharmaceutical composition that includes a therapeutically effective amount of testosterone undecanoate and a solubilizer. The testosterone undecanoate is solubilized in the composition and is present in an amount such that it comprises about 14 wt % to about 35 wt % of the total composition.Type: ApplicationFiled: August 14, 2015Publication date: December 22, 2016Applicant: Lipocine Inc.Inventors: Chandrashekar Giliyar, Basawaraj Chickmath, Nachiappan Chidambaram, Mahesh V. Patel, Srinivansan Venkateshwaran
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Publication number: 20160361322Abstract: Provided oral testosterone undecanoate compositions can be administered to hypogonadal males with a meal without the fat content of the meal substantially effecting bioavailability.Type: ApplicationFiled: June 15, 2016Publication date: December 15, 2016Applicant: Lipocine Inc.Inventors: Mahesh V. Patel, Nachiappan Chidambaram, Satish K. Nachaegari
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Patent number: 9498485Abstract: 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: GrantFiled: August 28, 2015Date of Patent: November 22, 2016Assignee: LIPOCINE INC.Inventors: Mahesh V. Patel, Nachiappan Chidambaram, Satish Kumar Nachaegari, Srinivasan Venkateshwaran, Joel Frank
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Patent number: 9480690Abstract: 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: November 25, 2015Date of Patent: November 1, 2016Assignee: Lipocine Inc.Inventors: Chandrashekar Giliyar, Basawaraj Chickmath, Nachiappan Chidambaram, Mahesh V. Patel, Srinivansan Venkateshwaran
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Patent number: 9399069Abstract: 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: February 27, 2015Date of Patent: July 26, 2016Assignee: Lipocine Inc.Inventors: Chandrashekar Giliyar, Srinivasan Venkateshwaran, Basawaraj Chickmath, Satish Kumar Nachaegari, Nachiappan Chidambaram, Mahesh V. Patel
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Publication number: 20160193228Abstract: 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: 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: 20160193225Abstract: Disclosed herein are compositions having a lipophilic active agent and methods of their use.Type: ApplicationFiled: August 31, 2015Publication date: July 7, 2016Applicant: Lipocine Inc.Inventors: Mahesh V. Patel, Nachiappan Chidambaram, Satish Kumar Nachaegari, Srinivasan Venkateshwaran, Joel Frank, Amy Jo Portlock