Rupturing Controlled Release Device Subcoat
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Solution Overview
Problem
Existing controlled release drug delivery devices with semipermeable membranes that rupture during use exhibit variability in release profiles, leading to inconsistent drug delivery.
Innovation Solution
Incorporating a rupture-controlling subcoat between the core and the semipermeable membrane to regulate the extent of membrane rupture and control drug release, reducing variability in release profiles to less than 15%, 10%, or 5% on a batch-to-batch or lot-to-lot basis.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If a semipermeable membrane ruptures during use to increase release rate, then complete delivery of active substance is achieved, but variability in release profiles increases
Solution Approach 1:
A subcoat layer is introduced as an intermediary between the core and the semipermeable membrane. This subcoat controls the extent and manner of membrane rupture, mediating between the internal pressure buildup and the external release environment. The subcoat ensures that rupture occurs in a controlled manner rather than catastrophically, thereby reducing variability in release profiles while maintaining the benefits of increased release rate.
Solution Approach 2:
The invention changes the physical and mechanical parameters of the membrane system by adding a subcoat with specific properties (thickness, composition, adhesion characteristics). This modifies the rupture behavior of the membrane, transforming it from an unpredictable catastrophic failure mode to a controlled, standardized release mechanism with reduced batch-to-batch variability.
2Reliability
If a subcoat is added to control membrane rupture, then release profile variability is reduced, but device complexity increases
Solution Approach 1:
The device is segmented into distinct functional layers: the core containing the active substance, the subcoat layer for controlling rupture, and the semipermeable membrane for selective permeability. This segmentation allows each layer to perform its specific function optimally, with the subcoat acting as a dedicated control element that simplifies the overall system behavior by standardizing the rupture process.
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 subcoat provides a reproducible drug release profile by controlling the extent and rate of membrane rupture, ensuring consistent and standardized drug delivery from the device.
Implementation Method 1
a semipermeable membrane surrounding the core
Implementation Method 2
the internal pressure of the device increases during use
Data Source
AI summary
The present invention provides a simple and improved rupturing controlled release device that is capable of providing a controlled release of active agent contained in the core first through a preformed passageway and then through an in situ formed second passageway into an environment of use in a standardized release profile manner. The rupturing controlled release device comprises a core comprising at least one drug and at least one osmopolymer, a semipermeable membrane enclosing the core and having at least one preformed passageway there through, wherein the semipermeable membrane ruptures during use to form a second passageway in the semipermeable membrane at a location spaced away from the preformed passageway, and a release-controlling subcoat between the core and the semipermeable membrane.