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 |
US9399069(B2) |
申请公布日期 |
2016.07.26 |
申请号 |
US201514633545 |
申请日期 |
2015.02.27 |
申请人 |
Lipocine Inc. |
发明人 |
Giliyar Chandrashekar;Venkateshwaran Srinivasan;Chickmath Basawaraj;Nachaegari Satish Kumar;Chidambaram Nachiappan;Patel Mahesh V. |
分类号 |
A61K31/56;A61K47/44;A61K9/48;A61K31/57;A61K9/20;A61K9/14;A61K9/16;A61K8/63;A61Q11/00;A61K47/10;A61K47/12;A61K47/14;A61K47/20;A61K47/22;A61K47/26;A61K47/32 |
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 micron or less, and a pharmaceutically acceptable carrier including at least one lipophilic 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 said oral pharmaceutical composition being in the form of a tablet or capsule. |
地址 |
Salt Lake City UT US |