High-strength testosterone undecanoate compositions
US10881671B2 · kind B2 · utility
Inventors
Key dates
| Filing date | Apr 8, 2020 |
| Grant date | Jan 5, 2021 |
| Priority date | — |
| Expiry date | Apr 8, 2040 |
Classification
- Technology area (CPC G)Physics
- CPC primaryG01N33/743
- WIPO fieldPharmaceuticals
- WIPO sectorChemistry
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.
Source: USPTO / EPO open patent data. Objective bibliographic and citation counts.