Invention Grant
- Patent Title: High-strength testosterone undecanoate compositions
-
Application No.: US16412360Application Date: 2019-05-14
-
Publication No.: US11433083B2Publication Date: 2022-09-06
- Inventor: Chandrashekar Giliyar , Basawaraj Chickmath , Nachiappan Chidambaram , Mahesh V. Patel , Srinivansan Venkateshwaran
- 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
- Agency: Thorpe North and Western, LLP
- Agent Michael R. Schramm; David W. Osborne
- Main IPC: A61K31/568
- IPC: A61K31/568 ; A61K9/00 ; A61K9/48 ; A61K47/12 ; A61K47/22 ; A61K47/44 ; G01N33/74

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.
Information query