Adhesive Patch with Diflucortolone Valerate for Skin Irritation

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Solution Overview

Problem

Transdermal patches often cause skin irritation and atrophy due to drugs, which existing multi-layered patches fail to adequately mitigate, and also face issues with detachment and adhesion during use.

Innovation Solution

A patch design featuring an adhesive layer with diflucortolone valerate and specific skin irritant drugs, such as asenapine or rivastigmine, within a rubber, acrylic, or silicone-based adhesive base, optimized to reduce skin irritation and atrophy by controlling the drug concentration and ratio, thereby enhancing adhesion and reducing side effects.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Object-affected harmful factors

If a multi-layered patch structure is used to separate the drug from the skin, then skin irritation is reduced, but the patch thickness increases leading to detachment and adhesion problems

Engineering Contradiction:
Improveskin irritationVSAvoidpatch thickness
Core Design Contradiction:
Object-affected harmful factorsVSLength of stationary object

Solution Approach 1:

The patent combines the drug-containing layer and adhesive layer into a single integrated adhesive layer, eliminating the need for a separate drug retaining layer. The skin irritant drug and diflucortolone valerate are incorporated directly into the adhesive layer, allowing the drug to be delivered while maintaining a thin profile that prevents detachment and adhesion issues.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The adhesive layer uses a composite formulation containing both a skin irritant drug and diflucortolone valerate (a corticosteroid). This composite material approach allows the drug to provide its therapeutic effect while diflucortolone valerate mitigates skin irritation, achieving both drug delivery and skin protection within a single thin layer.

Inventive Principle:
Principle #40Composite materials

2Object-affected harmful factors

If the adhesive layer contains both skin irritant drug and diflucortolone valerate, then skin irritation is mitigated, but the adhesive performance may be affected

Engineering Contradiction:
Improveskin irritationVSAvoidadhesive performance
Core Design Contradiction:
Object-affected harmful factorsVSReliability

Solution Approach 1:

The patent optimizes the concentration parameters of both the skin irritant drug and diflucortolone valerate within the adhesive layer. By carefully controlling the amounts of each component, the formulation achieves effective skin irritation mitigation while maintaining sufficient adhesive performance for reliable patch attachment.

Inventive Principle:
Principle #35Parameter changes

3Object-affected harmful factors

If diflucortolone valerate is added to reduce skin irritation, then skin atrophy is prevented, but the formulation complexity increases

Engineering Contradiction:
Improveskin atrophyVSAvoidformulation complexity
Core Design Contradiction:
Object-affected harmful factorsVSDevice complexity

Solution Approach 1:

The patent merges the drug delivery function and skin protection function into a single adhesive layer formulation. Diflucortolone valerate is incorporated directly into the adhesive layer along with the skin irritant drug, eliminating the need for separate protective layers and simplifying the overall patch structure while preventing skin atrophy.

Inventive Principle:
Principle #5Merging (Combining)

Data Source

PatentUS12151030B2Adhesive patch
Publication Date: 2024.11.26 HISAMITSU PHARM CO INC

AI summary

The present invention provides a patch comprising an adhesive layer on a backing, wherein the adhesive layer contains a adhesive base, a skin irritant drug or a pharmaceutically acceptable salt thereof, and diflucortolone valerate, and the content of the diflucortolone valerate is 0.0009 to 0.08% by mass based on the total mass of the adhesive layer.