- 专利标题: High-strength testosterone undecanoate compositions
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申请号: US16412360申请日: 2019-05-14
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公开(公告)号: US11433083B2公开(公告)日: 2022-09-06
- 发明人: Chandrashekar Giliyar , Basawaraj Chickmath , Nachiappan Chidambaram , Mahesh V. Patel , Srinivansan Venkateshwaran
- 申请人: Lipocine Inc.
- 申请人地址: US UT Salt Lake City
- 专利权人: Lipocine Inc.
- 当前专利权人: Lipocine Inc.
- 当前专利权人地址: US UT Salt Lake City
- 代理机构: Thorpe North and Western, LLP
- 代理商 Michael R. Schramm; David W. Osborne
- 主分类号: A61K31/568
- IPC分类号: A61K31/568 ; A61K9/00 ; A61K9/48 ; A61K47/12 ; A61K47/22 ; A61K47/44 ; G01N33/74
摘要:
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.
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