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US 10,328,022 B2Granted
Formulations and methods for vaginal delivery of antiprogestins
AssigneeRepros Therapeutics Inc.
InventorsJoseph S. Podolski, Kuang Hsu
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Abstract
The subject matter of the present invention is pertinent to the field of vaginal delivery of pharmaceutically active agents. Embodiments of the instant invention disclose methods for treating a variety of progesterone related disorders by vaginal administration of a pullulan capsule comprising one or more antiprogestins.
Claims6
A method for treating a progesterone-dependent condition in a human female comprising administering to the vaginal mucosa of the female a mucoadhesive capsule comprising:
- 85 to 90 wt % pullulan;
- potassium chloride in an amount of 1.0% to 1.5% by weight;
- carrageenan in an amount of 0.1% to 0.4% by weight;
- one or more surfactants in an amount of 0.1 to 0.2% by weights;
- and water;
- and
- a fill formulation comprising the antiprogestin CDB-4124, and excipients comprising 30% to 60% w/w fatty acid esters, 30% to 60% w/w PEG 1000 and 0.1 to 5% w/w lecithin;
- wherein the progesterone-dependent condition is selected from the group consisting of endometriosis, adenomyosis, edometriomas of the ovary, dysmenorrhea, uterine fibroids, endometrial hyperproliferation, ovarian cancer, and cervical cancer.
5 more elements
Dependencies are inferred from the claim text.