Multi-layered Vaginal Ring with Continuous Silicone Body
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Solution Overview
Problem
Existing vaginal drug delivery systems face issues with inconsistent release ratios of pharmaceutical actives over time due to diffusion through the device's material, leading to variable and often burst-like release patterns, which can affect efficacy and safety.
Innovation Solution
A multi-layered vaginal ring constructed from silicone elastomers with uniformly dispersed pharmaceutically active ingredients across layers, allowing for unimpeded diffusion and a continuous release profile, achieved through simultaneous extrusion and curing of layers to form a contiguous solid body.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If separate cured layers are joined to form a multi-layered vaginal ring, then the structural integrity and layer definition are improved, but the diffusion of pharmaceutical actives is impeded at the junctions between layers
Solution Approach 1:
The patent merges the layer formation and curing processes into a single simultaneous operation. Multiple layers of silicone elastomer containing different pharmaceutical actives are extruded and cured together in one continuous process, eliminating the separate curing and joining steps that create diffusion barriers. This results in a multi-layered ring where drug molecules can diffuse freely across what would otherwise be junction interfaces.
Solution Approach 2:
The patent performs the layer assembly action before the curing action. The different silicone elastomer layers are positioned and configured in their final multi-layered arrangement while still in the uncured, pliable state, allowing for easy assembly. Only after the layers are properly positioned are they cured simultaneously to lock in the structure, ensuring no diffusion barriers are created during assembly.
2Ease of manufacture
If separate layers are cured and joined together, then the manufacturing process can be simplified, but the release ratio of pharmaceutical actives changes over time
Solution Approach 1:
The patent combines multiple curing operations into a single simultaneous curing step. All layers are cured together in one process operation, eliminating the need for separate curing cycles for each layer and the subsequent joining operations. This single-step approach maintains composition stability by ensuring uniform curing across all layers and eliminating junctions where diffusion rates would differ.
Solution Approach 2:
The patent changes the curing parameter from sequential (different times for different layers) to simultaneous (all layers cured at the same time). This parameter change ensures that all layers reach their final cured state under identical conditions, preventing differential shrinkage or property changes that would alter the release ratios of pharmaceutical actives over time.
3Adaptability or versatility
If multiple separate curing steps are used for each layer, then each layer can be optimized independently, but the overall device complexity and manufacturing time increase
Solution Approach 1:
The patent merges the formulation and curing optimization into a single integrated process. By extruding and curing all layers simultaneously, the manufacturing process achieves the flexibility of independent layer optimization (through separate extrusion formulations) while avoiding the complexity of multiple curing cycles and assembly steps. The process complexity is reduced to a single coordinated operation.
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 solution provides a reduced burst effect and a more consistent release rate of pharmaceutical actives, enabling effective delivery of multiple ingredients with improved safety profiles and prolonged release durations.
Implementation Method 1
the plurality of layers comprising a continuous silicone body providing unimpeded diffusion of the pharmaceutically active ingredient from the at least one layer to the outer surface of the outer layer
Data Source
AI summary
Multi-layered vaginal rings 2 comprising silicone elastomers and pharmaceutically active ingredients are disclosed. The rings comprise a number of layers, at least one of which contains a pharmaceutically active ingredient, and each of which is a silicone elastomer. The multiple layers preferably are produced from these layers of different compositions, including an inner layer 4, a middle layer 5, and an outer layer 6. After extrusion and simultaneous curing, however, the ring 2 includes a contiguous body which comprises a continuous silicone body providing unimpeded diffusion of the pharmaceutically active ingredient from the inner layer (s) 4 to the outer layer (s) 6. Methods of producing these vaginal rings and of using them are also disclosed.