Rotigotine Patch Adhesive Composition for Harsh-Condition Stability

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Solution Overview

Problem

Existing rotigotine-containing patches using silicone-based, acrylic-based, or rubber-based adhesive agents face insufficient long-term stability under harsh conditions, necessitating a higher level of stabilization.

Innovation Solution

Incorporating cross-linked polyvinylpyrrolidone and alicyclic saturated hydrocarbon resin in the adhesive agent layer, along with a styrene-based thermoplastic elastomer, to stabilize rotigotine and its pharmaceutically acceptable salts for extended periods.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If silicone-based, acrylic-based, or rubber-based adhesive agents are used in rotigotine-containing patches, then the patches can be manufactured and applied, but the long-term stability of rotigotine under harsh conditions is insufficient

Engineering Contradiction:
Improvelong-term stability of rotigotineVSAvoidstability of rotigotine under harsh conditions
Core Design Contradiction:
ReliabilityVSStability of the object's composition

Solution Approach 1:

The patent introduces cross-linked polyvinylpyrrolidone as an intermediary substance between rotigotine and the adhesive agent. This mediator prevents direct interaction that causes degradation, thereby improving long-term stability without compromising the functionality of existing adhesive agents.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent creates a composite adhesive system by combining the base adhesive agent (silicone-based, acrylic-based, or rubber-based) with cross-linked polyvinylpyrrolidone and alicyclic saturated hydrocarbon resin. This composite material provides both the adhesive properties needed for patch application and the stabilization needed for long-term rotigotine stability under harsh conditions.

Inventive Principle:
Principle #40Composite materials

2Reliability

If cross-linked polyvinylpyrrolidone and alicyclic saturated hydrocarbon resin are incorporated in the adhesive agent layer, then rotigotine stability is improved, but the device complexity increases

Engineering Contradiction:
Improvestability of rotigotineVSAvoidcomplexity of adhesive agent layer composition
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent merges multiple functional components into a single integrated adhesive agent layer. The cross-linked polyvinylpyrrolidone, alicyclic saturated hydrocarbon resin, and base adhesive agent are combined in one layer, eliminating the need for separate stabilization layers and simplifying the overall patch structure while achieving enhanced stability.

Inventive Principle:
Principle #5Merging (Combining)

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 method achieves high-level stabilization of rotigotine and its salts in the adhesive agent layer, maintaining stability and skin permeability under harsh conditions.

Implementation Method 1

Incorporating cross-linked polyvinylpyrrolidone and alicyclic saturated hydrocarbon resin in the adhesive agent layer, along with a styrene-based thermoplastic elastomer, to stabilize rotigotine and its pharmaceutically acceptable salts for extended periods

Methodology Applied
Scientific EffectStabilization:

Implementation Method 2

The method achieves high-level stabilization of rotigotine and its salts in the adhesive agent layer, maintaining stability and skin permeability under harsh conditions

Methodology Applied
Scientific EffectPermeation: Permeation

Data Source

PatentEP3925606B1Rotigotine stabilization method
Publication Date: 2026.03.11 HISAMITSU PHARM CO INC
  • EP3925606B1 patent drawing
  • EP3925606B1 patent drawing

AI summary

The present invention provides a rotigotine stabilization method for stabilizing rotigotine and/or a pharmaceutically acceptable salt thereof in a rotigotine-containing patch comprising a backing layer and an adhesive agent layer, the adhesive agent layer containing the rotigotine and/or the pharmaceutically acceptable salt thereof and a styrene-based thermoplastic elastomer, the method comprising further incorporating cross-linked polyvinylpyrrolidone in the adhesive agent layer in a content of 3 to 25% by mass in the adhesive agent layer.