Formulations and methods for vaginal delivery of antiprogenstins
AssigneeAllergan Pharmaceuticals International Limited
InventorsJoseph S. Podolski, Kuang Hsu
Life of this patent
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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.
Claims17
A pharmaceutical formulation for vaginal use, comprising a mucoadhesive capsule comprising pullulan and a capsule fill formulation comprising CDB-2914 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 formulations lacking isopropyl myristate or isopropyl palmitate.
A pharmaceutical formulation for vaginal use, comprising:
- (i) a mucoadhesive capsule comprising pullulan in an amount of 86.3% by weight, potassium chloride in an amount of 1.32% by weight, carrageenan in an amount of 0.27% by weight, surfactants selected from sugar esters, sorbitan monolaurate and combinations thereof in an amount of 0.15% by weight and water;
- and,
- (ii) a capsule fill formulation comprising CDB-2914 or a pharmaceutically acceptable salt thereof, in an excipient mixture of about 4% (w/w) isopropyl myristate;
- about 95.98% PEG 1000 and between 0.01% w/w and 0.03% w/w BHT, wherein the pharmaceutical formulation is used for at least 10 weeks, and
- 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.
Dependencies are inferred from the claim text.