发明名称 |
17-hydroxyprogesterone ester-containing oral compositions and related methods |
摘要 |
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° 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. |
申请公布号 |
US8951996(B2) |
申请公布日期 |
2015.02.10 |
申请号 |
US201113193571 |
申请日期 |
2011.07.28 |
申请人 |
Lipocine Inc. |
发明人 |
Giliyar Chandrashekar;Venkateshwaran Srinivasan;Chickmath Basawaraj;Nachaegari Satish Kumar;Nachiappan Chidambaram;Patel Mahesh V. |
分类号 |
A61K31/56;A61K9/48;A61K31/57;A61K9/20;A61K9/14;A61K9/16 |
主分类号 |
A61K31/56 |
代理机构 |
Thorpe North & Western LLP |
代理人 |
Thorpe North & Western LLP |
主权项 |
1. An oral pharmaceutical composition, comprising: a therapeutically effective amount of 17-hydroxyprogesterone caproate having a mean particulate diameter of about 50 μm or less, and a pharmaceutically acceptable carrier including at least one hydrophilic additive;
wherein the amount of the 17-hydroxyprogesterone caproate is from about 5% to about 80% w/w of the total composition; and wherein, when measured using a USP Type-II dissolution apparatus in 900 mL of simulated intestinal fluid having 0.5% w/w sodium lauryl sulfate at 50 RPM at 37° C., at least 20% of the 17-hydroxyprogesterone caproate is released from the oral composition at 60 minutes. |
地址 |
Salt Lake City UT US |