Transdermal Permeant Delivery System With Electrical Microporation
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Solution Overview
Problem
Current methods for transdermal drug delivery face challenges in efficiently overcoming the barrier of the stratum corneum, particularly in providing continuous and convenient administration of drugs over extended periods without causing discomfort or harm.
Innovation Solution
A transdermal permeant delivery system that creates microscopic holes (micropores) in the skin using a substrate with a filament array and a patch reservoir, allowing for the controlled release of drugs through formed micropores, enhancing permeability and facilitating the transport of therapeutic substances.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If thermal microporation techniques are used to form micropores in the stratum corneum, then transdermal permeability is enhanced, but thermal damage and pain may occur
Solution Approach 1:
The patent replaces thermal energy with electrical energy (electrical discharge) to create micropores in the stratum corneum. Instead of using heat to denature proteins and create pores, the invention uses controlled electrical discharges to mechanically rupture the lipid matrix, thereby avoiding thermal damage to surrounding tissues while achieving effective transdermal permeability enhancement.
Solution Approach 2:
The invention changes the energy parameter from thermal to electrical by applying controlled electrical discharges with specific voltage, current, and pulse duration parameters. This parameter change allows pore formation through electrical field-induced lipid disruption rather than thermal denaturation, eliminating the harmful thermal effects while maintaining pore formation efficacy.
2Reliability
If pyrotechnic elements are used to create artificial openings in the biological membrane, then permeability is enhanced, but tissue trauma and pain are caused
Solution Approach 1:
The patent replaces mechanical/pyrotechnical methods with electrical discharge methods. Instead of using exploding pins or mechanical puncture devices that physically tear tissue, the invention uses controlled electrical discharges to non-mechanically disrupt the lipid bilayer structure, creating pores without mechanical trauma to the underlying viable tissue.
Solution Approach 2:
The invention introduces electrical energy as an intermediary mechanism between the external device and the biological membrane. The electrical discharge acts as a mediator that transfers energy to disrupt lipid structures without requiring direct mechanical contact or force application to the tissue, thereby avoiding trauma while achieving permeability enhancement.
3Duration of action of moving object
If oral or injection routes are used for drug delivery, then continuous delivery over extended periods is achieved, but convenience and comfort are reduced
Solution Approach 1:
The invention segments the drug delivery system into two functional components: a microporation device that creates transient pores and a transdermal patch that delivers the drug. This segmentation allows the pore-forming step to be brief and painless, while the drug delivery phase can continue over extended periods through the created pores, combining the advantages of both short-term and long-term delivery methods.
Solution Approach 2:
The invention performs preliminary action by creating micropores in the stratum corneum before applying the drug-containing patch. This preliminary pore formation step enables subsequent continuous drug delivery through the pre-opened pathways, eliminating the need for repeated injection or oral administration while providing prolonged convenient delivery.
4Reliability
If the stratum corneum barrier function is maintained, then protection from exogenous substances is provided, but transdermal flux of drugs is limited
Solution Approach 1:
The invention applies local quality by creating micropores only in the stratum corneum layer where drug delivery is needed, while leaving the underlying viable tissue and its protective functions intact. The electrical discharges are confined to the superficial lipid-rich stratum corneum, selectively disrupting barrier function locally at the application site without compromising overall skin protection or causing deep tissue damage.
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
Enables rapid and painless delivery of drugs and bio-active compositions across the skin, overcoming the barrier of the stratum corneum, allowing for extended and controlled release of therapeutic agents, including macromolecules like peptides and proteins.
Implementation Method 1
Each filament is configured for conductively delivering thermal energy via direct contact to the tissue membrane to cause ablation of a portion of the membrane
Implementation Method 2
cause ablation of a portion of the membrane... enabling rapid and painless delivery of a permeant across the skin
Data Source
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AI summary
A transdermal permeant delivery system for delivery of at least one permeant composition into a tissue membrane of a subject including a disposable substrate having at least a portion of a bottom surface of a first release liner connected to an upper surface of the substrate and a patch having a backing layer and a reservoir that is selectively removable from the top surface of the first release liner. In a connected position, a first portion of the backing layer of the patch is releaseably mounted to a top surface of the first release liner in spaced registration with a poration area of the substrate.