Transdermal Patch Elastic Porous Backing Adhesion Irritation

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Solution Overview

Problem

Extended wear dermal delivery patches face issues with inadequate adhesion and skin irritation, particularly due to the use of skin permeation enhancers like dimethyl sulfoxide and long chain aliphatic compounds, which can cause irritation and detachment problems.

Innovation Solution

The design of a transdermal drug delivery patch with a polymeric matrix comprising a pressure-sensitive adhesive and an elastic, porous backing material, which minimizes irritation and enhances adhesion by reducing physical stress and moisture buildup, allowing for extended wear without significant irritation or detachment.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If skin permeation enhancers (DMSO, long chain aliphatic compounds) are used to enhance transdermal delivery, then drug penetration through skin is improved, but skin irritation increases

Engineering Contradiction:
Improvetransdermal delivery rateVSAvoidskin irritation
Core Design Contradiction:
ProductivityVSObject-affected harmful factors

Solution Approach 1:

The patent introduces an intermediary substance (such as a carrier oil, cream base, or formulation excipient) that facilitates the delivery of the skin permeation enhancer while simultaneously reducing its direct contact with and irritation to the skin. This intermediary acts as a buffer between the harmful enhancer and the skin surface, allowing enhanced drug penetration while mitigating irritation effects.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent modifies parameters of the skin permeation enhancer formulation, such as changing the concentration, molecular weight, or chemical structure of the enhancer, or adjusting the formulation's pH, viscosity, or composition. These parameter changes allow the enhancer to maintain its permeation-enhancing capability while reducing its irritant potential through optimized formulation characteristics.

Inventive Principle:
Principle #35Parameter changes

2Duration of action of moving object

If extended wear patches are designed for 3 or more days, then treatment duration is improved, but adhesion reliability deteriorates

Engineering Contradiction:
Improvewear periodVSAvoidadhesion
Core Design Contradiction:
Duration of action of moving objectVSReliability

Solution Approach 1:

The patent applies preliminary actions to the adhesive layer or backing material during manufacturing, such as pre-treating the surface with primers, coatings, or chemical modifications that enhance adhesion performance over extended wear periods. This preliminary preparation ensures that the adhesive maintains strong bonding throughout the entire wear duration, preventing detachment before it occurs.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent employs composite materials in the patch construction, combining multiple layers or materials with complementary properties. For example, using a composite adhesive system that includes both a pressure-sensitive adhesive and additional bonding agents, or a multi-layer backing structure that provides both flexibility and adhesion, thereby achieving reliable attachment throughout extended wear periods.

Inventive Principle:
Principle #40Composite materials

3Reliability

If pressure sensitive adhesive is used in the active ingredient layer, then adhesion to skin is improved, but skin irritation from the adhesive increases

Engineering Contradiction:
ImproveadhesionVSAvoidadhesive-induced irritation
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent introduces an intermediary layer or substance between the pressure-sensitive adhesive and the skin, such as a protective coating, barrier layer, or formulation matrix that reduces direct skin contact with the adhesive while maintaining adhesion functionality. This intermediary protects the skin from adhesive-induced irritation while preserving the patch's bonding capability.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent modifies the parameters of the pressure-sensitive adhesive formulation, such as adjusting the adhesive's chemical composition, molecular weight, or concentration to reduce its irritant properties while maintaining adequate adhesion performance. This parameter optimization allows the adhesive to bond effectively without causing excessive skin irritation.

Inventive Principle:
Principle #35Parameter changes

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 patch achieves cumulative moderate irritation of less than 5% and a meaningful degree of detachment of less than 20% over a seven-day wear period, improving adhesion and reducing skin irritation through careful formulation and design, eliminating the need for irritation inhibitors and rate-controlling membranes.

Implementation Method 1

an active ingredient (AI) layer... comprising a pressure sensitive adhesive

Methodology Applied
Scientific EffectAdhesion: Adhesive

Implementation Method 2

an elastic and porous backing material

Methodology Applied
Scientific EffectElasticity: Elasticity

Implementation Method 3

an elastic and porous backing material

Methodology Applied
Scientific EffectDiffusion: Diffusion

Data Source

PatentUS20240390289A1Dermal Delivery Device
Publication Date: 2024.11.28 AGILE THERAPEUTICS INC
  • US20240390289A1 patent drawing
  • US20240390289A1 patent drawing

AI summary

A transdermal drug delivery device is disclosed. Over an extended wear period, the device causes cumulative moderate irritation plus significant irritation of less than 5% and/or achieves a meaningful degree of detachment over a seven day period of less than 20%.