Biodegradable Reservoir Membrane for Zero-Order Subcutaneous Drug Release
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Solution Overview
Problem
Current long-acting (LA) drug delivery systems for biomedical interventions, such as HIV PrEP, face challenges with adherence to time- or event-driven regimens and potential adverse drug-related events, while existing implants do not achieve zero-order drug release kinetics for sustained, user-independent delivery.
Innovation Solution
A biodegradable, permeable polymer membrane reservoir device with a thickness of at least 45 μm allows for zero-order release of active agents, such as Tenofovir alafenamide fumarate (TAF), 4′-ethynyl-2-fluoro-2′-deoxyadenosine (EFdA), or Levonorgestrel (LNG), providing sustained delivery over at least 60 days subcutaneously.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Duration of action of moving object
If a biodegradable polymer membrane with thickness of at least 45 μm is used, then zero-order drug release kinetics is achieved providing sustained delivery over at least 60 days, but the device complexity increases
Solution Approach 1:
The patent applies parameter changes by optimizing the polymer membrane thickness to at least 45 μm and selecting specific biodegradable polymers (PLA, PGA, PLGA, PCL) with controlled degradation rates. These parameter adjustments enable zero-order release kinetics while maintaining structural integrity for sustained delivery over 60+ days, resolving the contradiction between duration and complexity.
Solution Approach 2:
The patent utilizes composite material systems combining biodegradable polymers (PLA, PGA, PLGA, PCL) with active pharmaceutical ingredients. This composite approach enables controlled drug release through the polymer matrix while the biodegradation process naturally provides the sustained delivery mechanism, achieving zero-order kinetics without complex mechanical structures.
2Productivity
If injectable formulations are used for long-acting delivery, then bi-monthly dosing regimen is achieved, but the potential exists for long plasma tail of sub-therapeutic drug levels and cannot be removed in event of adverse event
Solution Approach 1:
The patent extracts the drug delivery function from systemic circulation by using a localized subcutaneous reservoir device. This extraction approach eliminates the plasma tail effect and enables controlled local release, resolving the reliability issue while maintaining bi-monthly dosing productivity.
Solution Approach 2:
The patent implements preliminary action by pre-formulating drugs in biodegradable polymer reservoirs designed for sustained release. The device is prepared in advance with controlled release characteristics, ensuring consistent drug levels over bi-monthly periods and enabling removal if adverse events occur, thus resolving both productivity and reliability concerns.
3Reliability
If daily or on-demand dosing of Tenofovir-based PrEP is used, then effective prevention is achieved, but adherence to time- or event-driven regimens remains a struggle
Solution Approach 1:
The patent applies self-service by designing a biodegradable reservoir device that automatically delivers Tenofovir-based PrEP without user intervention. The device self-regulates drug release through polymer degradation and diffusion mechanisms, maintaining effective prevention while eliminating adherence challenges associated with daily or on-demand dosing regimens.
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 device achieves a flat PK profile with minimal drug tail after depletion, enabling effective, long-term delivery of various active agents with high stability and adherence, suitable for a wide range of therapeutics and preventatives.
Implementation Method 1
The membrane allows for diffusion of an active agent of the formulation there through when positioned subcutaneously in a body of a subject
Data Source
AI summary
A reservoir device comprising an active agent formulation contained within a reservoir is described. The reservoir is defined by a biodegradable, permeable polymer membrane having a thickness of at least 45 μm. The membrane allows for diffusion of an active agent of the formulation there through when positioned subcutaneously in a body of a subject.