Estriol vaginal ring
AssigneeVaRi Bioscience GmbH
InventorKlaus NICKISCH
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Abstract
Disclosed is a vaginal ring delivering estriol. The ring is suitable for use in the treatment of vaginal and vulva atrophy. It has a core-shell structure of ethylene vinyl acetate copolymers. Both the core and the shell are loaded with estriol, with the concentration of estriol in the core exceeding that in the shell. The core and shell have a different copolymer composition, with the vinyl acetate in the core being higher than that in the shell.
Claims20
A vaginal ring loaded with estriol as the sole active pharmaceutical ingredient, said vaginal ring comprising a core made of ethylene vinyl acetate random copolymer having a vinyl acetate content in a range of from 20 wt. % to 40 wt. %, said core being surrounded by a shell made of ethylene vinyl acetate random copolymer having a vinyl acetate content in a range of from 4 wt. % to 28 wt. %, wherein both the core and the shell are loaded with estriol.
A method of treatment of vaginal and vulva atrophy, the method comprising administering to a woman in need thereof estriol in a dosage regimen comprising an initial hypertherapeutic dosing and a subsequent maintenance dosing, wherein the estriol is provided by administering a vaginal ring according to claim 20.
A blend comprising estriol blended into ethylene vinyl acetate random copolymer, wherein the copolymer has a vinyl acetate content in a range of from 4 wt. % to 19 wt. % and the estriol is present in a concentration in a range of from 0.01 wt. % to 1.5 wt. %.
A vaginal ring loaded with estriol as the sole active pharmaceutical ingredient, said vaginal ring comprising
- a core made of ethylene vinyl acetate random copolymer having a vinyl acetate content in a range of from 20 wt. % to 40 wt. %, said core being surrounded by a shell made of ethylene vinyl acetate random copolymer having a vinyl acetate content in a range of from 4 wt. % to 28 wt. %,
- wherein both the core and the shell are loaded with estriol,
- wherein the core is loaded with estriol in a concentration in a range of from 0.2 wt. % to 5 wt. % and wherein the shell is loaded with estriol in a concentration in a range of from 0.01 wt. % to 1 wt. %,
- wherein the shell thickness ranges from 80 μm to 120 μm, and
- wherein the ring cross-sectional diameter ranges from 2.5 mm to 7.5 mm.
Dependencies are inferred from the claim text.