Invention Grant
- Patent Title: High-strength testosterone undecanoate compositions
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Application No.: US14298768Application Date: 2014-06-06
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Publication No.: US09358241B2Publication Date: 2016-06-07
- Inventor: Chandrashekar Giliyar , Srinivasan Venkateshwaran , Basawaraj Chickmath , Nachiappan Chidambaram , Mahesh V Patel
- Applicant: Lipocine Inc.
- Applicant Address: US UT Salt Lake City
- Assignee: LIPOCINE INC.
- Current Assignee: LIPOCINE INC.
- Current Assignee Address: US UT Salt Lake City
- Main IPC: A61K9/48
- IPC: A61K9/48 ; A61P15/08 ; A61K31/568 ; A61K9/16

Abstract:
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.
Public/Granted literature
- US20140303130A1 HIGH-STRENGTH TESTOSTERONE UNDECANOATE COMPOSITIONS Public/Granted day:2014-10-09
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