Reusable Vaginal Ring with Segesterone Acetate and Ethinyl Estradiol Cores
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Solution Overview
Problem
Current contraceptive methods, such as oral pills and subcutaneous implants, face compliance issues due to daily reminders and the need for frequent refills, while intravaginal rings like NuvaRing require regular prescription refills and have limitations in duration and convenience.
Innovation Solution
A reusable vaginal system comprising a silicone elastomer ring body with cores containing segesterone acetate and ethinyl estradiol, designed to release specific amounts of these hormones for up to 13 cycles of 21 days each, with a high percentage of ethinyl estradiol recoverability after storage, and compatibility with various condom materials.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If oral contraception pills are used, then contraception effectiveness is maintained, but user compliance deteriorates due to daily pill reminder and frequent refill requirements
Solution Approach 1:
The contraceptive system is segmented into a reusable ring body and replaceable drug cores. The ring body serves as a permanent implant that remains in the vagina for extended periods (up to 13 cycles), while only the drug cores need replacement. This segmentation allows the majority of the system to remain in place continuously, eliminating daily compliance issues, while only requiring periodic core replacement every few months.
Solution Approach 2:
The ring body is pre-inserted and remains in place for extended periods, performing the function of hormone delivery preparation in advance. The drug cores are pre-loaded into the ring body during manufacturing or initial setup, so that the system is ready for continuous operation without requiring daily user intervention or frequent refills.
2Duration of action of moving object
If subcutaneous implants or IUDs are used, then contraception duration is extended beyond one year, but medical professional intervention deteriorates due to insertion and removal requirements
Solution Approach 1:
The vaginal ring system is designed for self-insertion and self-removal by the user, eliminating the need for medical professional intervention. The flexible ring body can be easily inserted into the vagina by the user themselves, and similarly removed when needed. This self-service capability extends contraception duration to up to 13 cycles while avoiding the medical intervention requirement of implants and IUDs.
3Ease of operation
If NuvaRing is used, then monthly refill convenience is improved, but refill frequency deteriorates due to 21-day discard and new insertion requirement
Solution Approach 1:
Multiple drug cores are combined into a single reusable ring body that remains in place for extended periods. Instead of discarding the entire ring after 21 days as with NuvaRing, this system keeps the ring body in place and simply replaces the drug cores periodically. This merging of the permanent ring structure with replaceable drug supplies reduces refill frequency from monthly to every few months, saving time and improving convenience.
4Reliability
If the vaginal system uses high ethinyl estradiol content, then contraception effectiveness is improved, but drug stability deteriorates during storage due to hydrosilylation reactions
Solution Approach 1:
The drug cores are formulated with specific local compositions and protective structures that isolate the ethinyl estradiol from reactive components in the ring body. The cores may have specialized coatings or matrix structures that prevent direct contact between the hormone and hydrosilane groups in the silicone elastomer, allowing high drug content to be maintained while preventing degradation reactions during storage.
Solution Approach 2:
An intermediary protective layer or coating is introduced between the ethinyl estradiol drug and the reactive hydrosilane groups in the silicone elastomer ring body. This intermediary prevents direct interaction and hydrosilylation reactions, allowing the system to maintain both high drug content for effectiveness and chemical stability during extended storage periods.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The system provides effective contraception for extended periods with minimal user intervention, maintaining hormone release efficacy and compatibility with secondary contraception methods, enhancing user convenience and reducing the need for frequent refills.
Implementation Method 1
the system is configured to release an approximate average of 0.15 mg/day of segesterone acetate and an approximate average of 0.013 mg/day of ethinyl estradiol
Data Source
AI summary
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.