Biphasic Iontophoretic Patch for Controlled Drug Delivery

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Solution Overview

Problem

Current methods for pain management, such as IV and oral delivery of opioids, are ineffective for breakthrough pain, prone to addiction, and risk overdose or underdose due to unpredictable pharmacokinetics, and transdermal iontophoretic systems face issues with over-administration through passive diffusion.

Innovation Solution

A biphasic transdermal iontophoretic system with a delivery current and a holding current to control the administration of therapeutic agents, allowing for on-demand initiation and cyclical delivery, minimizing passive diffusion and preventing over-administration, using electrode assemblies and a controller to manage the delivery regimen.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If transdermal iontophoretic system delivers therapeutic agent continuously through passive diffusion, then drug delivery is simplified, but over-administration and overdose risk increase

Engineering Contradiction:
Improvedrug delivery simplicityVSAvoidover-administration risk
Core Design Contradiction:
Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The system implements periodic delivery cycles with alternating delivery phase (current off) and holding phase (current on) to control therapeutic agent delivery. The delivery phase allows passive diffusion into the skin, while the holding phase uses iontophoretic current to repel the agent back into the reservoir, preventing over-administration through continuous delivery

Inventive Principle:
Principle #19Periodic action

Solution Approach 2:

The controller monitors delivery parameters and automatically switches between delivery and holding phases based on pre-programmed protocols. This feedback control ensures precise dosing by stopping delivery when the predetermined dose is reached or time elapsed, preventing excessive administration

Inventive Principle:
Principle #23Feedback

2Measurement precision

If iontophoretic current is applied to deliver therapeutic agent, then drug delivery control is improved, but device complexity increases

Engineering Contradiction:
Improvedrug delivery control precisionVSAvoidsystem complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The system uses the patient's own skin as the delivery medium and the therapeutic agent's charge as the driving force. The iontophoretic current leverages the natural electrostatic repulsion between like charges to propel the charged therapeutic agent through the skin, eliminating the need for complex mechanical pumping or injection mechanisms

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The system replaces complex mechanical drug delivery mechanisms with electrical fields. Instead of using pumps, syringes, or mechanical pressure systems to deliver the therapeutic agent, the invention uses iontophoretic current to electrically repel charged molecules through the skin barrier, simplifying the overall device architecture

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

3Ease of operation

If oral medication is used for pain management, then administration is simple, but addiction and overdose risk increase

Engineering Contradiction:
Improveadministration simplicityVSAvoidaddiction and overdose risk
Core Design Contradiction:
Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The system extracts the therapeutic agent from the gastrointestinal tract environment and delivers it directly through the skin. By bypassing the oral route, the invention eliminates first-pass metabolism, unpredictable absorption, and the associated risks of addiction and overdose while maintaining simple patient administration through a wearable patch

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The skin serves as an intermediary delivery route between the therapeutic agent and systemic circulation. This intermediate transdermal pathway provides controlled, steady-state drug delivery with predictable pharmacokinetics, reducing the risks associated with oral administration while maintaining ease of use

Inventive Principle:
Principle #24Intermediary (Mediator)

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 system effectively delivers therapeutic agents like opioids and antiemetics while minimizing adverse effects by controlling the delivery cycles and preventing over-administration, ensuring precise and safe pain management.

Implementation Method 1

transdermal iontophoretic delivery of therapeutic agents... applying first and second patches to the skin... A first current is delivered to the skin and creates a first driving force to transport the agent into the skin

Methodology Applied
Scientific EffectIontophoresis: Iontophoresis

Implementation Method 2

The electrical charge repels ionized (i.e., charged) forms of the drug or other therapeutic agent

Methodology Applied
Scientific EffectIon repulsion: Ion Repulsion/Attraction

Implementation Method 3

A second current is delivered to the skin and creates a second driving force to oscillate the agent in a direction substantially parallel to the skin

Methodology Applied
Scientific EffectElectromotive force: Electric Field

Implementation Method 4

the pain medication continues to passively diffuse from the patch reservoir into the patient even when iontophoretic current is off due to concentration gradients between the patch and the skin

Methodology Applied
Scientific EffectPassive diffusion: Diffusion

Data Source

PatentEP2688639B1System for biphasic transdermal iontophoretic delivery of therapeutic agents
Publication Date: 2019.09.18 INCUBE LABS LLC
  • EP2688639B1 patent drawingFigure 1
  • EP2688639B1 patent drawingFigure 2
  • EP2688639B1 patent drawingFigure 3a

AI summary

Various embodiments provide methods and systems for the biphasic iontophoretic transdermal delivery of therapeutic agents. An embodiment of a method for such delivery comprises positioning at least one electrode assembly in electrical communication with a patient's skin. The assembly includes a solution comprising a therapeutic agent which passively diffuses into the skin. A dose of agent is delivered from the assembly into the skin during a first period using a first current having a characteristic e.g., polarity and magnitude, to repel the agent out of the assembly. During a second period, a second current having a characteristic to attract the agent is used to retain the agent in the assembly such that delivery of agent into skin is minimized. A dose of agent may be delivered on demand by an input from the patient. Embodiments may be used for delivery of agents which cause adverse effects from unwanted passive diffusion.