17-hydroxyprogesterone ester-containing oral compositions and related methods

US10709716B2 · kind B2 · utility

Assignee

• Lipocine, Inc. · US

Inventors

• Chandrashekar Giliyar · Plymouth, US
• Srinivasan Venkateshwaran · Salt Lake City, US
• Basawaraj Chickmath · Minneapolis, US
• Satish Kumar Nachaegari · Salt Lake City, US
• Nachiappan Chidambaram · Salt Lake City, US
• Mahesh V. Patel · Salt Lake City, US

Key dates

• Filing date: Mar 28, 2019
• Grant date: Jul 14, 2020
• Expiry date: Mar 28, 2039

Classification

• Technology area (CPC A): Human Necessities
• CPC primary: A61K2800/10
• WIPO field: Pharmaceuticals
• WIPO sector: Chemistry

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.