System for providing birth control
The present disclosure relates to a vaginal system that prevents pregnancy comprised of segesterone acetate and ethinyl estradiol and is configured for thirteen 28-day product-use cycles.
1. A reusable vaginal ring system for preventing pregnancy comprising:
a) a silicone elastomer ring body, having a platinum concentration of approximately 3 ppm to approximately 10 ppm and a hydride/vinyl ratio from approximately 1:1 to approximately 1.3:1 before curing, the ring body comprising
i. a first cylindrical channel comprising a first circumferential wall, wherein the first cylindrical channel is adapted to receive a first cylindrical core;
ii. a second cylindrical channel comprising a second circumferential wall, wherein the second cylindrical channel is adapted to receive a second cylindrical core;
b) a medical adhesive for adhering cores in the first and second cylindrical channels;
c) a first cylindrical core comprising first and second condensation-cure silicone elastomers, dibutyltin dilaurate, and a viscosity agent and further comprising a first circumferential surface and at least a first circumferential face, the first cylindrical core being disposed within the first cylindrical channel, wherein approximately all of the first circumferential surface is in adhesive communication with the first circumferential wall;
d) a second cylindrical core comprising a third condensation-cure silicone elastomer and dibutyltin dilaurate and further comprising a second circumferential surface and at least a second circumferential face, the second cylindrical core being disposed within the second cylindrical channel, wherein approximately all of the second circumferential surface is in adhesive communication with the second circumferential wall;
e) approximately 103 mg of segesterone acetate and approximately 17.4 mg of ethinyl estradiol, wherein both the segesterone acetate and the ethinyl estradiol are contained within the cores of the vaginal ring;
wherein the system releases an approximate average of 0.15 mg/day of segesterone acetate and an approximate average of 0.013 mg/day of ethinyl estradiol, or bioequivalent amounts thereof, for up to 13 cycles of 21 days each; and
wherein approximately 80% to approximately 90% of the ethinyl estradiol is recoverable from the system after approximately 18 months of storage at 25° C. and 60% relative humidity.
2. The vaginal ring system of claim 1 , wherein the first and second channels contain, in total, approximately 160 mg to about 220 mg of medical adhesive.
3. The vaginal ring system of claim 2 , wherein the first channel contains approximately 90 mg to approximately 130 mg of medical adhesive and wherein the second channel contains approximately 30 mg to approximately 90 mg of medical adhesive.
4. The vaginal ring system of claim 1 , wherein all of the first circumferential surface is in adhesive communication with the first circumferential wall and all of the second circumferential surface is in adhesive communication with the second circumferential wall.
5. The vaginal ring system of claim 1 , wherein approximately all of the first circumferential face is in adhesive communication at least with the first circumferential wall and wherein approximately all of the second circumferential face is in adhesive communication with at least the second circumferential wall.
6. The vaginal ring system of claim 1 , wherein one of the two cores contains segesterone acetate and the other contains segesterone acetate and ethinyl estradiol.