3D-Printed Intravaginal Ring Architectures for Tunable Drug Release
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Solution Overview
Problem
Current intravaginal ring (IVR) manufacturing technologies face limitations in drug stability, design complexity, drug diffusion rate, and the inability to simultaneously deliver multiple drugs effectively for HIV prevention and other health indications, necessitating the development of geometrically complex IVRs with tunable drug release.
Innovation Solution
Geometrically complex intravaginal rings (IVRs) fabricated using 3D printing technologies, such as CLIP, allowing precise control over drug release rates, loading capacity, and integration of multiple drugs, with customizable designs for extended drug delivery.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional injection molding or hot-melt extrusion is used to manufacture intravaginal rings, then the manufacturing process is established and scalable, but the high temperatures and pressures compromise drug stability and limit design complexity
Solution Approach 1:
The patent replaces traditional mechanical manufacturing processes (injection molding, hot-melt extrusion) with 3D printing technology. This substitution eliminates the need for high temperatures and pressures, thereby preserving drug stability while enabling geometrically complex intravaginal ring designs with customized architectures for controlled drug release
Solution Approach 2:
The patent changes the manufacturing parameters from high temperature and pressure conditions to ambient or controlled low-temperature conditions enabled by 3D printing. This parameter change allows drugs to maintain stability while the process accommodates complex geometries and customized drug delivery profiles
2Ease of manufacture
If conventional matrix IVR design is used, then the manufacturing process is simplified, but the drug diffusion rate is limited and cannot be tuned
Solution Approach 1:
The patent segments the intravaginal ring into geometrically complex structures with varying architectures. This segmentation enables different regions to have tailored porosity and drug diffusion rates, allowing precise control over drug release kinetics while maintaining manufacturability through 3D printing
Solution Approach 2:
The patent employs porous materials and structures within the intravaginal ring design. The porous architecture increases surface area and facilitates controlled drug diffusion, enabling tunable release rates that can be optimized for specific therapeutic needs while remaining compatible with 3D printing manufacturing
3Ease of manufacture
If single-drug IVRs are manufactured, then the device design and manufacturing are straightforward, but the ability to prevent multiple conditions (HIV, STDs, unwanted pregnancies) is limited
Solution Approach 1:
The patent designs intravaginal rings with multi-functionality by integrating multiple drugs into a single device. The 3D printing approach enables complex multi-chamber or gradient structures that can deliver different drugs at different rates, allowing one device to address HIV prevention, STD prevention, and contraception simultaneously
Solution Approach 2:
The patent uses composite material systems containing multiple drugs with different properties. The 3D printing process enables spatial distribution of different drug-loaded materials within the ring structure, creating a composite system that provides multifunctional protection while maintaining manufacturing feasibility
4Reliability
If oral PrEP with daily dosing is used, then the drug can reach the FGT, but adherence is variable and liver metabolism reduces efficacy
Solution Approach 1:
The patent implements sustained-release intravaginal rings that deliver drugs at controlled rates over extended periods (weeks to months). This partial dosing approach maintains therapeutic drug levels at the target site without requiring daily user action, thereby improving adherence while achieving reliable drug delivery to the female genital tract
Solution Approach 2:
The intravaginal ring is designed as a self-service device that automatically delivers drugs at predetermined rates without requiring user intervention after insertion. This self-service mechanism ensures consistent drug delivery over the device's lifespan, eliminating adherence issues associated with daily dosing while maintaining reliable therapeutic levels
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 3D printed IVRs provide enhanced drug release control, enabling long-term delivery of multiple drugs, improving HIV prevention and addressing other health issues like STDs and unwanted pregnancies, with improved patient adherence and cost-effectiveness compared to traditional methods.
Implementation Method 1
3D printing technologies, such as CLIP
Implementation Method 2
a plurality of unit cells, the unit cells comprising a macroscopic and/or microscopic architecture, wherein the plurality of unit cells together form the body of the ring structure
Data Source
AI summary
Geometrically complex intravaginal rings, systems and methods of making the same are provided herein. Disclosed herein are geometrically complex intravaginal rings with tunable and enhanced drug release, which in some embodiments can be fabricated by 3D printing technologies. The disclosed IVRs include a ring structure comprising a plurality of unit cells or macroscopic and/or microscopic architecture, which can be tuned to control the loading capacity of an active compound within the IVR, the diffusion of an active compound from the IVR, the surface area of the IVR, and/or the mechanical properties of the IVR. The disclosed geometrically complex IVRs can provide superior control over drug loading and drug release compared to conventional IVRs fabricated by injection molding or hot-melt extrusion.