Vaginal Ring Drug Delivery System with Core-Skin Architecture
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Solution Overview
Problem
Current intra-vaginal ring (IVR) designs face challenges in simultaneously releasing multiple therapeutic agents, such as CCR5 inhibitors and HIV integrase inhibitors, due to stability issues, difficulty in adjusting release rates, manufacturing complexity, and inability to meet therapeutic release criteria, particularly in achieving high release rates for anti-viral drugs.
Innovation Solution
The vaginal ring drug delivery system features a core with a first therapeutic agent dissolved in a thermoplastic polymer and a skin surrounding the core with a second therapeutic agent in solid form, allowing for independent adjustment of release rates and higher diffusion rates due to reduced diffusion length, thereby overcoming the limitations of previous systems.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If a skin surrounds the core in the IVR system, then the release rate of therapeutic agents can be controlled, but the diffusion length increases and release rate decreases
Solution Approach 1:
The IVR system is segmented into distinct functional layers: a core layer containing therapeutic agents and a skin layer with controlled permeability. This segmentation allows the core to provide high concentration of drugs while the skin controls release rate, effectively resolving the contradiction between diffusion length and release rate by separating the reservoir function from the rate-control function.
Solution Approach 2:
Different regions of the IVR system have different properties optimized for their specific functions. The core region has high drug concentration and permeability for maximum availability, while the skin region has controlled permeability and appropriate thickness for rate control. This local optimization allows simultaneous achievement of high release rate and controlled diffusion.
2Adaptability or versatility
If multiple therapeutic agents are released from a single IVR device, then comprehensive HIV prevention is achieved, but the device complexity and manufacturing difficulty increase
Solution Approach 1:
Multiple therapeutic agents with different release requirements are merged into a single IVR device with a unified multi-layer structure. The core layer accommodates multiple drugs while the skin layer provides unified rate control, enabling comprehensive HIV prevention through combination therapy without requiring multiple separate devices.
Solution Approach 2:
The IVR system is designed as a universal platform capable of delivering multiple therapeutic agents simultaneously. The multi-layer architecture with core and skin components can accommodate various drug combinations for HIV prevention, making the device versatile and adaptable to different treatment protocols without increasing fundamental structural complexity.
3Reliability
If the skin thickness is increased to control release rate, then release rate decreases, but stability upon storage and transport improves
Solution Approach 1:
The skin thickness parameter is optimized to specific ranges that balance storage stability and release rate requirements. By carefully selecting and controlling the skin thickness parameter during manufacturing, the system achieves both adequate protection during storage/transport and sufficient drug release during use, resolving the contradiction between these two requirements.
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
This configuration enables sustained release of therapeutic agents over an extended period, achieving the desired therapeutic effect by allowing higher release rates and independent adjustment of drug release, addressing the limitations of previous IVR designs.
Implementation Method 1
higher diffusion rates due to reduced diffusion length
Implementation Method 2
a skin surrounding the core with a second therapeutic agent in solid form, allowing for independent adjustment of release rates
Data Source
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AI summary
Described herein is a vaginal ring drug delivery system comprising (i) a core comprising a first thermoplastic polymer and a first therapeutic agent, wherein the first therapeutic agent is dissolved in the first thermoplastic polymer, and (ii) a skin surrounding the core comprising a second thermoplastic polymer and a second therapeutic agent, wherein the second therapeutic agent is in solid form.