Formulations and methods for vaginal delivery of antiprogestins
AssigneeAllergan Pharmaceuticals International Limited
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 and a fill formulation comprising one or more antiprogestins dispersed in a mixture of isopropyl palmitate or isopropyl myristate and a polyethylene glycol.
Claims21
-22. (canceled)
A formulation for vaginal use, comprising a mucoadhesive capsule comprising pullulan and a capsule fill formulation comprising a SPRM or a pharmaceutically acceptable salt thereof dispersed in an excipient mixture comprising (a) isopropyl myristate or isopropyl palmitate and (b) a polyethylene glycol, wherein the capsule fill formulation produces an increased AUC with vaginal administration as compared to a capsule fill formulation lacking isopropyl myristate or isopropyl palmitate.
A method of treating a progesterone-dependent condition in a subject in need thereof, the method comprising:
- administering a mucoadhesive capsule comprising pullulan and a capsule fill formulation to the vaginal mucosa of the subject,
- wherein the capsule fill formulation comprises a SPRM or a pharmaceutically acceptable salt thereof dispersed in an excipient mixture comprising (a) isopropyl myristate or isopropyl palmitate and (b) a polyethylene glycol, wherein the capsule fill formulation produces an increased AUC with vaginal administration as compared to a capsule fill formulation lacking isopropyl myristate or isopropyl palmitate to the vaginal mucosa of the patient, and
- wherein the progesterone-dependent condition is selected from the group consisting of endometriosis, adenomyosis, endometriomas of the ovary, dysmenorrhea, uterine fibroids, endometrial hyperproliferation, ovarian cancer, and cervical cancer.
Dependencies are inferred from the claim text.