Intravaginal Ring Hydrophilic Elastomers for Zero-Order Drug Release
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Solution Overview
Problem
Current intravaginal drug delivery devices, particularly intravaginal rings, face limitations in delivering hydrophilic drugs and macromolecules due to the hydrophobic nature of existing polymers, leading to high manufacturing costs and user discomfort, and are not suitable for thermal-sensitive biologics.
Innovation Solution
Intravaginal devices utilizing hydrophilic elastomers, such as hydrophilic polyurethanes, surround a drug reservoir to enable zero-order release of a wide range of substances, including hydrophilic and hydrophobic drugs and macromolecules, without the need for thermal processing, thus overcoming solubility and mechanical stiffness issues.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If silicone or pEVA polymers are used in intravaginal rings, then the device can be manufactured with existing technology, but the device cannot deliver hydrophilic drugs and macromolecules effectively
Solution Approach 1:
The patent changes the fundamental parameter of polymer hydrophobicity to hydrophilicity by selecting polymers with water contact angles less than 90 degrees. This parameter change enables the polymer matrix to effectively deliver hydrophilic drugs and macromolecules while maintaining controlled release characteristics.
Solution Approach 2:
The patent employs composite material systems combining hydrophilic polymers with specific drug formulations. The composite structure includes the hydrophilic polymer matrix, drug payload, and potentially surfactants or pore-forming agents to optimize drug release kinetics for different drug types.
2Force
If silicone IVRs are fabricated with larger cross-sectional diameters to achieve retractive forces, then the device can be retained in the vaginal cavity, but the manufacturing costs increase
Solution Approach 1:
The patent changes the material parameter from hydrophobic silicone to hydrophilic elastomers, which provides different mechanical properties including adequate retractive force. This material substitution allows for optimized device dimensions that reduce manufacturing complexity and cost while maintaining sufficient retention force.
3Strength
If thermoplastics are used instead of silicone, then the mechanical stiffness is improved, but the device cannot deliver hydrophilic drugs effectively
Solution Approach 1:
The patent changes the polymer parameter from hydrophobic to hydrophilic character while maintaining elastomeric properties. This enables the material to provide both adequate mechanical stiffness and compatibility with hydrophilic drugs and macromolecules through its water-attracting properties.
4Device complexity
If conventional polymers are used, then the device structure is simple, but thermal processing is required which degrades biologics
Solution Approach 1:
The patent changes the processing parameter from thermal to non-thermal fabrication methods. This allows the incorporation of heat-sensitive biologics into the device without degradation, while the device structure remains relatively simple through alternative manufacturing approaches such as solvent casting or extrusion at lower temperatures.
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 devices provide a cost-effective, user-compliant, and sustained delivery of drugs, including biologics, with a zero-order release profile, suitable for various drugs, including antivirals and contraceptives, addressing the limitations of existing technologies.
Implementation Method 1
the drug is released by diffusion through the polymer matrix
Implementation Method 2
hydrophilic elastomer... capable of providing a zero order release of loaded drugs
Data Source
AI summary
Intravaginal drug delivery devices, including intravaginal rings, are provided herein. The devices include a reservoir of at least one vaginally administrable drug wherein the reservoir is surrounded at least in part by a hydrophilic elastomer. The devices are capable of exhibiting a substantially zero order release profile of drug over extended periods of time. Also disclosed are methods for making the devices and methods of using the devices to prevent or treat a biological condition.