Transdermal Patch Backing Film Overlap Prevents Leakage

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Solution Overview

Problem

Transdermal application systems face issues with active substance leakage and degradation due to cold-flowing matrices, leading to contamination risks and reduced efficacy over time, especially during storage.

Innovation Solution

The design incorporates an active substance-containing matrix between an impermeable backing layer and a removable protective film, with the backing layer overlapping the matrix edges to prevent escape and include a cover layer that adheres to the protective film, ensuring the matrix remains contained and stable.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Stability of the object's composition

If a planar self-adhesive patch with an adhesive core surrounded by an adhesive ring is used to prevent cold-flowing, then the adhesive stability is improved, but the device complexity increases

Engineering Contradiction:
Improveadhesive stabilityVSAvoiddevice complexity
Core Design Contradiction:
Stability of the object's compositionVSDevice complexity

Solution Approach 1:

The adhesive system is segmented into an adhesive core and an adhesive ring with different properties. The adhesive core provides the necessary adhesion while the adhesive ring with reduced flowability prevents cold-flowing. This segmentation allows each part to perform its specific function independently, resolving the contradiction between adhesive stability and device complexity.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

Different regions of the adhesive system have different qualities: the adhesive ring has reduced flowability compared to the adhesive core. This local quality differentiation prevents cold-flowing at the edges while maintaining adhesion in the core area, solving the stability issue without requiring complex overall device architecture.

Inventive Principle:
Principle #3Local quality

2Reliability

If the backing layer overlaps the matrix edges to prevent active substance leakage, then the containment reliability is improved, but the manufacturing precision requirements increase

Engineering Contradiction:
Improvecontainment reliabilityVSAvoidmanufacturing precision
Core Design Contradiction:
ReliabilityVSManufacturing precision

Solution Approach 1:

The backing layer is designed to overlap the matrix edges in advance, creating a preventive barrier against active substance leakage before any leakage can occur. This preliminary geometric configuration ensures containment reliability without requiring complex real-time control mechanisms during manufacturing.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The backing layer functions as a flexible impermeable film that extends beyond the matrix edges. This thin film approach provides effective containment while being tolerant to reasonable manufacturing variations, reducing the stringency of precision requirements compared to tight-fit designs.

Inventive Principle:
Principle #30Flexible shells and thin films

3Stability of the object's composition

If a protruding backing film design is used to prevent matrix flow and active ingredient leakage, then the storage stability is improved, but the device complexity increases

Engineering Contradiction:
Improvestorage stabilityVSAvoiddevice complexity
Core Design Contradiction:
Stability of the object's compositionVSDevice complexity

Solution Approach 1:

The backing layer extends in the lateral dimension beyond the matrix edges, creating a three-dimensional overlapping structure. This dimensional extension provides effective containment of the matrix and active ingredients during storage without requiring complex mechanical or chemical control systems.

Inventive Principle:
Principle #17Another dimension (Dimensionality change)

Solution Approach 2:

The system combines the matrix material with an impermeable backing layer material to create a composite structure. The backing layer material provides the necessary barrier properties and structural support to prevent cold-flowing and leakage, while the overall design remains relatively simple.

Inventive Principle:
Principle #40Composite materials

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

This configuration effectively prevents active substance leakage and matrix degradation, maintaining the active ingredient content and stability during storage and use, reducing contamination risks and ensuring consistent drug delivery.

Implementation Method 1

the backing layer is designed to overlap the edges of the matrix

Methodology Applied
Scientific EffectPhysical containment: Physical Containment

Implementation Method 2

the active ingredient is delivered into the patient's skin by diffusion along the drug concentration gradient that exists between the TDS matrix and the area of the skin supplied by the blood vessels

Methodology Applied
Scientific EffectDiffusion: Diffusion

Implementation Method 3

The overtape is applied to the side of the TDS facing away from the skin, over the laminate of drug-containing matrix and drug-impermeable backing layer

Methodology Applied
Scientific EffectAdhesion: Adhesive

Data Source

PatentEP2658532B1Transdermal application system comprising a protruding backing film
Publication Date: 2019.12.11 LUYE PHARMA AG
  • EP2658532B1 patent drawingFigure 1a~2b
  • EP2658532B1 patent drawingFigure 3a~4

AI summary

The invention relates to a transdermal application system in which a matrix (1) containing active substance is arranged between a backing layer (2) that is impermeable to the active substance and a peelable protective film (3). The backing layer (2) is designed in such a way as to overlap the edges of the matrix (1).