公开(公告)号：US20130029957A1

公开(公告)日：2013-01-31

申请号：US13193571

申请日：2011-07-28

Applicant: Chandrashekar Giliyar ,  Srinivasan Venkateshwaran ,  Basawaraj Chickmath ,  Satish Kumar Nachaegari ,  Chidambaram Nachiappan ,  Mahesh V. Patel

Inventor： Chandrashekar Giliyar ,  Srinivasan Venkateshwaran ,  Basawaraj Chickmath ,  Satish Kumar Nachaegari ,  Chidambaram Nachiappan ,  Mahesh V. Patel

IPC: A61K31/56 ,  A61P15/00

CPC classification number: A61K31/57 ,  A61K8/63 ,  A61K9/0053 ,  A61K9/14 ,  A61K9/145 ,  A61K9/1617 ,  A61K9/1623 ,  A61K9/1635 ,  A61K9/1641 ,  A61K9/1652 ,  A61K9/1676 ,  A61K9/2013 ,  A61K9/2018 ,  A61K9/2031 ,  A61K9/2054 ,  A61K9/2059 ,  A61K9/4841 ,  A61K9/4858 ,  A61K9/4866 ,  A61K47/10 ,  A61K47/12 ,  A61K47/14 ,  A61K47/20 ,  A61K47/22 ,  A61K47/26 ,  A61K47/32 ,  A61K47/44 ,  A61K2800/10 ,  A61Q11/00

Abstract: 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.