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AssigneeLipocine Inc.
InventorsChandrashekar Giliyar, Srinivasan Venkateshwaran, Basawaraj Chickmath, Satish Kumar Nachaegari, Chidambaram Nachiappan, Mahesh V Patel
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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.
1-54. (canceled)
A method of treating a pregnant female subject at risk of preterm birth, comprising, administering to the female subject an oral pharmaceutical composition comprising:
A method of treating a pregnant female subject at risk of preterm birth, comprising, administering to the female subject a pharmaceutically acceptable oral dosage form comprising:
A method of treating a pregnant female subject at risk of preterm birth, comprising, administering to the female subject the pharmaceutically acceptable oral dosage form comprising:
Dependencies are inferred from the claim text.