Patents by Inventor Mahesh V. Patel
Mahesh V. Patel has filed for patents to protect the following inventions. This listing includes patent applications that are pending as well as patents that have already been granted by the United States Patent and Trademark Office (USPTO).
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Publication number: 20200390785Abstract: 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 25, 2020Publication date: December 17, 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: 20200383997Abstract: 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 8, 2020Publication date: December 10, 2020Applicant: Lipocine Inc.Inventors: Chandrashekar Giliyar, Basawaraj Chickmath, Nachiappan Chidambaram, Mahesh V. Patel, Srinivansan Venkateshwaran
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Publication number: 20200383998Abstract: 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 25, 2020Publication date: December 10, 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: 20200383999Abstract: 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: March 13, 2020Publication date: December 10, 2020Applicant: Lipocine Inc.Inventors: Chandrashekar Giliyar, Nachiappan Chidambaram, Mahesh V. Patel, Srinivasan Venkateshwaran
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Publication number: 20200360402Abstract: 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 30, 2020Publication date: November 19, 2020Applicant: Lipocine Inc.Inventors: Chandrashekar Giliyar, Basawaraj Chickmath, Nachiappan Chidambaram, Mahesh V. Patel, Srinivansan Venkateshwaran
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Patent number: 10799513Abstract: 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: October 13, 2020Assignee: Lipocine Inc.Inventors: Chandrashekar Giliyar, Basawaraj Chickmath, Nachiappan Chidambaram, Mahesh V. Patel, Srinivansan Venkateshwaran
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Publication number: 20200282061Abstract: Pharmaceutical compositions and dosage forms for administration of hydrophobic drugs, particularly steroids, are provided. The pharmaceutical compositions include a therapeutically effective amount of a hydrophobic drug, preferably a steroid; a solubilizer, preferably a vitamin E substance; and a surfactant. The synergistic effect between the hydrophobic drug and the vitamin E substance 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: March 13, 2020Publication date: September 10, 2020Applicant: Lipocine Inc.Inventors: Feng-Jing Chen, Mahesh V. Patel, David T. Fikstad, Huiping Zhang, Chandrashekar Gilyar
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Publication number: 20200237782Abstract: 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 8, 2020Publication date: July 30, 2020Applicant: Lipocine Inc.Inventors: Chandrashekar Giliyar, Basawaraj Chickmath, Nachiappan Chidambaram, Mahesh V. Patel, Srinivansan Venkateshwaran
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Publication number: 20200237781Abstract: 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 8, 2020Publication date: July 30, 2020Applicant: Lipocine Inc.Inventors: Chandrashekar Giliyar, Basawaraj Chickmath, Nachiappan Chidambaram, Mahesh V. Patel, Srinivansan Venkateshwaran
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Publication number: 20200230152Abstract: 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 8, 2020Publication date: July 23, 2020Applicant: Lipocine Inc.Inventors: Chandrashekar Giliyar, Basawaraj Chickmath, Nachiappan Chidambaram, Mahesh V. Patel, Srinivansan Venkateshwaran
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Patent number: 10716794Abstract: 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 24, 2018Date of Patent: July 21, 2020Assignee: Lipocine Inc.Inventors: Chandrashekar Giliyar, Basawaraj Chickmath, Nachiappan Chidambaram, Mahesh V. Patel, Srinivansan Venkateshwaran
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Publication number: 20200222426Abstract: 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: December 26, 2019Publication date: July 16, 2020Applicant: Lipocine Inc.Inventors: Nachiappan Chidambaram, Satish Kumar Nachaegari, Mahesh V. Patel, Kilyoung Kim
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Publication number: 20200222425Abstract: 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: December 24, 2019Publication date: July 16, 2020Applicant: Lipocine Inc.Inventors: Mahesh V. Patel, Nachiappan Chidambaram, Satish K. Nachaegari
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Patent number: 10709716Abstract: 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: March 28, 2019Date of Patent: July 14, 2020Assignee: Lipocine Inc.Inventors: Chandrashekar Giliyar, Srinivasan Venkateshwaran, Basawaraj Chickmath, Satish Kumar Nachaegari, Nachiappan Chidambaram, Mahesh V. Patel
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Publication number: 20200188304Abstract: 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: ApplicationFiled: November 13, 2019Publication date: June 18, 2020Applicant: Lipocine Inc.Inventors: Basawaraj Chickmath, Chandrashekar Giliyar, Nachiappan Chidambaram, Mahesh V. Patel, Srinivasan Venkateshwaran
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Publication number: 20200155570Abstract: 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: July 19, 2019Publication date: May 21, 2020Applicant: Lipocine Inc.Inventors: Mahesh V. Patel, Nachiappan Chidambaram, Satish K. Nachaegari, Burke Byrne, Kilyoung Kim, Jonathan A. Baker
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Patent number: 10653706Abstract: 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: May 19, 2020Assignee: Lipocine Inc.Inventors: Chandrashekar Giliyar, Basawaraj Chickmath, Nachiappan Chidambaram, Mahesh V. Patel, Srinivansan Venkateshwaran
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Publication number: 20200069805Abstract: 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: ApplicationFiled: June 14, 2019Publication date: March 5, 2020Applicant: Lipocine Inc.Inventors: David T. Fikstad, Chandrashekar Giliyar, Srinivasan Venkateshwaran, Mahesh V. Patel
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Publication number: 20200069701Abstract: 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 8, 2019Publication date: March 5, 2020Applicant: Lipocine Inc.Inventors: Chandrashekar Giliyar, Basawaraj Chickmath, Nachiappan Chidambaram, Mahesh V. Patel, Srinivansan Venkateshwaran
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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