Adhesive Patch Package Bag with Oxygen Scavenger

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Solution Overview

Problem

Existing package bags for ropinirole-containing adhesive patches suffer from issues such as crystal precipitation and drug decomposition, leading to coloration and reduced efficacy.

Innovation Solution

A package bag design featuring a sealant layer, a barrier layer of aluminum, and an oxygen scavenger, with a relative humidity of 35% or higher at 4°C, using resins like polyacrylonitrile, polyethylene, or polyester, and an outer layer of polyethylene terephthalate or cellophane, to prevent crystal precipitation and inhibit drug decomposition.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional package bags are used to store ropinirole-containing adhesive patches, then the patches can be stored, but crystal precipitation and drug decomposition occur leading to coloration and reduced efficacy

Engineering Contradiction:
Improvedrug stabilityVSAvoidcrystal precipitation and decomposition
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent applies an inert atmosphere by incorporating an oxygen scavenger inside the package bag to remove oxygen and create an oxygen-free environment. This prevents oxidative decomposition of ropinirole and eliminates the harmful effects of oxygen exposure during storage, directly resolving the contradiction between maintaining drug stability and preventing decomposition.

Inventive Principle:
Principle #39Inert atmosphere (Inert environment)

Solution Approach 2:

The package bag uses a multi-layer composite structure combining different materials: a sealant layer (polyacrylonitrile, polyethylene, or polyester), an aluminum barrier layer, and an outer layer (polyethylene terephthalate or cellophane). This composite structure provides superior barrier properties against moisture and oxygen compared to conventional single-layer bags, preventing crystal precipitation and drug decomposition while maintaining reliability.

Inventive Principle:
Principle #40Composite materials

2Reliability

If the package bag uses a multi-layer structure with barrier layers, then drug protection is improved, but manufacturing complexity increases

Engineering Contradiction:
Improveprotection against decompositionVSAvoidpackage bag structure
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The package bag is segmented into distinct functional layers: a sealant layer for sealing and inner protection, an aluminum barrier layer for blocking moisture and oxygen, and an outer layer for mechanical strength and exterior protection. This segmentation allows each layer to perform its specific function optimally while maintaining overall reliability against decomposition.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The multi-layer package bag structure serves multiple functions simultaneously: the sealant layer provides sealing and chemical compatibility, the aluminum layer provides barrier protection, and the outer layer provides mechanical strength. This multi-functionality achieves superior drug protection without requiring additional separate components, thereby managing complexity through integrated design.

Inventive Principle:
Principle #6Universality (Multi-functionality)

3Reliability

If oxygen scavenger is added to the package bag, then drug decomposition is inhibited, but device complexity and cost increase

Engineering Contradiction:
Improveprevention of drug decompositionVSAvoidpackage bag components
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The oxygen scavenger operates autonomously inside the package bag, automatically absorbing oxygen without requiring external intervention, power sources, or complex control systems. This self-service mechanism provides reliable prevention of drug decomposition while adding minimal complexity, as the scavenger simply needs to be placed inside the bag and performs its function passively over time.

Inventive Principle:
Principle #25Self-service

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 solution effectively prevents crystal precipitation and suppresses coloration, maintaining the drug's stability and efficacy within the adhesive patch during storage.

Implementation Method 1

the package bag further comprises an oxygen scavenger as deoxygenation means

Methodology Applied
Scientific EffectOxygen scavenging: Absorption (physical)

Implementation Method 2

a barrier layer made of aluminum between the sealant layer and the outer layer

Methodology Applied
Scientific EffectBarrier layer blocking: Physical Containment

Data Source

PatentEP2431034B1Adhesive patch-containing package bag and method for storing adhesive patch
Publication Date: 2016.08.10 HISAMITSU PHARM CO INC
  • EP2431034B1 patent drawingFigure 1
  • EP2431034B1 patent drawingFigure 2

AI summary

The present invention relates to an adhesive patch-containing package bag 1, having: a package bag 8; and an adhesive patch 10 stored inside the package bag 8, wherein the adhesive patch 10 has a backing 12, an adhesive layer 14 laminated on at least one side of the backing 12 and containing ropinirole and/or a pharmaceutically acceptable salt thereof, and a release liner 16 covering the adhesive layer 14, and a relative humidity at 4°C is maintained at 35% or higher inside the package bag 8.