Lipocine Inc.

Other

Spriaso LLC

Satish Kumar Nachaegari

Mahesh V Patel

Nachiappan Chidambaram

Srinivasan Venkateshwaran

Chandrashekar Giliyar

Basawaraj Chickmath

Kilyoung Kim

Joel Frank

Srinivansan Venkateshwaran

Chidambaram Nachiappan

Jonathan Baker

Burke Byrne

Raj Patel

Chidambaram Machiappan

Amy Jo Portlock

Provided oral testosterone undecanoate compositions can be administered to hypogonadal males with a meal without the fat content of the meal substantially effecting bioavailability.

Composition and method for oral delivery of androgen prodrugs

Disclosed are methods and compositions for testosterone replacement therapy, especially for use in administration to hypogonadal males. The methods and compositions employ an untitrated dose dosing regimen that does not require titration or dose adjustments and that can provide a therapeutically effective amount of a testosterone ester, such as a non-undecanoate testosterone ester, while avoiding unacceptably high testosterone levels.

Oral testosterone therapy

Disclosed are bioavailable solid state (17-β)-Hydroxy-4-Androsten-3-one esters suitable for pharmaceutical uses and administration to mammals in need of (17-β)-Hydroxy-4-Androsten-3-one. Pharmaceutical compositions and the dosage forms of the bioavailable solid state (17-β)-Hydroxy-4-Androsten-3-one esters can be used to treat any condition associated with testosterone deficiency, including complete absence of endogenous testosterone in male or female subjects.

Bioavailable solid state (17-beta)-hydroxy-4-androsten-3-one esters

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.

Liver disease

Bioavailable solid state (17-β)-Hydroxy-4-Androsten-3-one esters

Described here are substantially pure (17-&#x3b2;)-3-Oxoandrost-4-en-17-yl tridecanoate compositions, methods of their preparation and uses thereof.

(17-&#xdf;)-3-oxoandrost-4-en-17YL tridecanoate compositions and methods of their preparation and use

Disclosed are methods and compositions for testosterone replacement therapy, especially for use in administration to hypogonadal males. 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 non-undecanoate testosterone ester while avoiding unacceptably high testosterone levels.

Oral testosterone non-undecanoate therapy

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&#xb0; 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.

17-hydroxyprogesterone ester-containing oral compositions and related methods

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.

Oral testosterone undecanoate therapy

Disclosed are bioavailable solid state (17-&#x3b2;)-Hydroxy-4-Androsten-3-one esters suitable for pharmaceutical uses and administration to mammals in need of (17-&#x3b2;)-Hydroxy-4-Androsten-3-one.

Growing community of inventors

Salt Lake City, UT, United States of America

Satish Kumar Nachaegari