Cyclic Polyolefin Plastic Ampule for Drug Stability

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Solution Overview

Problem

Plastic ampules face challenges with low moldability, water vapor permeation, and fragment scattering during opening, which affect the stability and handling of drug solutions.

Innovation Solution

A plastic ampule made of a single layer of cyclic polyolefin with a glass transition temperature between 50°C to 104°C, featuring a bung, cap, and a thinner section for easy opening, which enhances moldability, water vapor barrier properties, and reduces fragment scattering.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of manufacture

If a plastic ampule is made from conventional polyolefin materials to ensure ease of manufacture and impact resistance, then moldability and safety are improved, but water vapor barrier property deteriorates

Engineering Contradiction:
ImprovemoldabilityVSAvoidwater vapor barrier property
Core Design Contradiction:
Ease of manufactureVSReliability

Solution Approach 1:

The patent changes the material parameter by selecting cyclic polyolefin with a specific glass transition temperature range (50°C to 104°C), which fundamentally alters the material's barrier properties while maintaining its processing characteristics. This parameter change enables the material to achieve both good moldability and superior water vapor barrier performance simultaneously.

Inventive Principle:
Principle #35Parameter changes

2Ease of operation

If the ampule wall is made thinner to reduce material usage and improve ease of opening, then ease of operation is improved, but strength and resistance to piercing deteriorate

Engineering Contradiction:
Improveease of openingVSAvoidresistance to piercing
Core Design Contradiction:
Ease of operationVSStrength

Solution Approach 1:

The patent applies local quality by creating a thinner section specifically at the opening portion of the ampule, while the main body maintains sufficient thickness for strength. This localized thinning allows easy opening at the cutting portion while preserving the overall structural integrity and resistance to piercing of the ampule body.

Inventive Principle:
Principle #3Local quality

3Reliability

If glass ampules are used to ensure excellent water vapor barrier property, then reliability is improved, but strength against impact and safety deteriorate

Engineering Contradiction:
Improvewater vapor barrier propertyVSAvoidstrength against impact
Core Design Contradiction:
ReliabilityVSStrength

Solution Approach 1:

The patent employs a disposable plastic ampule that replaces fragile glass containers. The cyclic polyolefin material provides sufficient barrier properties for single-use applications while offering superior impact resistance and safety. The ampule is designed for single-use disposal, eliminating the need for sterilization and handling of fragile glass.

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

4Manufacturing precision

If a thicker cutting part is used to ensure stability of shape after opening, then manufacturing precision is improved, but ease of opening and reduction of fragment scattering deteriorate

Engineering Contradiction:
Improvestability of cutting part shapeVSAvoidease of opening
Core Design Contradiction:
Manufacturing precisionVSEase of operation

Solution Approach 1:

The patent applies local quality by making the cutting part thinner than the main body while maintaining adequate shape stability. The localized thinning at the cutting portion facilitates easy breaking and reduces fragment scattering, while the overall design ensures the cut portion maintains sufficient structural stability for handling after opening.

Inventive Principle:
Principle #3Local quality

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 prevents cracks during molding, maintains excellent moldability and water vapor barrier properties, and stabilizes the cutting part after opening, ensuring safe handling and effective drug solution storage.

Implementation Method 1

a cyclic polyolefin with a glass transition temperature of 50°C to 104°C

Methodology Applied
Scientific EffectGlass transition temperature:

Implementation Method 2

the decrease in the drug solution content due to permeation of the drug solution outside of the container can be reduced as much as possible by ensuring a certain water vapor barrier property

Methodology Applied
Scientific EffectPermeation: Permeation

Data Source

PatentEP2695594B1Plastic ampule
Publication Date: 2016.01.20 OTSUKA PHARMACEUTICAL FACTORY INC
  • EP2695594B1 patent drawingFigure 1~2
  • EP2695594B1 patent drawingFigure 3~4
  • EP2695594B1 patent drawingFigure 5

AI summary

A plastic ampule of the present invention is composed of a single layer of a plastic layer consisting only of a cyclic polyolefin with a glass transition temperature of 50°C to 104°C; integrally comprises an ampule body formed in a bottle shape with a top part and a bottom part and having a bung for discharging a drug solution on the top part, a cap attached to the ampule body so as to seal the bung, and a thinner part having a layer thickness thinner than those of the ampule body and the cap, formed along a circumferential direction of the bung and connecting between the ampule body and the cap; and is opened by breaking off or twisting off the thinner part as a cutting part between the ampule body and the cap.