Pharmaceutical Glass Composition for Durability and Devitrification Resistance

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Solution Overview

Problem

Existing pharmaceutical glass containers face challenges with chemical durability, transparency, and devitrification resistance, particularly when storing aqueous-based medicaments containing macromolecules, which can lead to glass component elution and formation of insoluble foreign matters, potentially causing thrombosis and pain.

Innovation Solution

A glass composition with specific ranges of SiO2, Al2O3, B2O3, Li2O, Na2O, K2O, CaO, BaO, and other components is formulated to enhance chemical durability, transparency, and devitrification resistance, with controlled ratios to maintain low working temperatures and reduce glass erosion.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If the content of SiO2 or Al2O3 is increased to improve chemical durability, then the chemical durability is improved, but the working temperature becomes high

Engineering Contradiction:

Improvechemical durabilityVSAvoidworking temperature

Core Design Contradiction:

ReliabilityVSTemperature

Solution Approach 1:

The invention changes the chemical composition parameters of the glass by introducing specific ratios of alkaline earth metal oxides (CaO: 0.1-5.0%, BaO: 0.1-3.0%) and controlling the SiO2 (60-80%) and Al2O3 (1-15%) content, which modifies the glass network structure to achieve both high chemical durability and low working temperature

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The invention creates a composite glass system combining multiple oxides (SiO2, B2O3, Al2O3, CaO, BaO, and others) in specific proportions, where each component contributes different properties: SiO2 provides chemical durability, B2O3 lowers melting point, and CaO/BaO balance chemical resistance with processability

Inventive Principle:

Principle #40Composite materials

2Reliability

If BaO is preferentially added over CaO to achieve low working temperature and improved chemical durability, then the working temperature is lowered and chemical durability is improved, but barium feldspar crystals are likely to be precipitated by reaction with alumina-based refractory during glass melting, causing devitrification resistance to deteriorate and productivity to decrease

Engineering Contradiction:

Improvechemical durabilityVSAvoidproductivity

Core Design Contradiction:

ReliabilityVSProductivity

Solution Approach 1:

The invention precisely controls the BaO content within 0.1-3.0% and maintains a specific CaO/BaO ratio, preventing the formation of barium feldspar crystals during melting while still achieving the desired chemical durability and low working temperature

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The invention applies different alkaline earth metal oxides (CaO and BaO) in specific proportions to different functional requirements: CaO provides chemical durability while BaO contributes to low melting point, with their combined ratio optimized to prevent devitrification

Inventive Principle:

Principle #3Local quality

3Difficulty of detecting and measuring

If the glass container transparency is increased to improve foreign matter inspection visibility, then the inspection capability is improved, but the content of iron and titanium contributing to coloring must be strictly controlled

Engineering Contradiction:

Improveforeign matter inspection capabilityVSAvoidcontent of iron and titanium

Core Design Contradiction:

Difficulty of detecting and measuringVSQuantity of substance

Solution Approach 1:

The invention sets strict upper limits on iron oxide (0.01-0.5%) and titanium dioxide (0.01-0.5%) content in the glass composition, and introduces MoO3 (0.01-1.0%) as a color correction agent to enhance transparency for better foreign matter detection

Inventive Principle:

Principle #35Parameter changes

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 glass composition achieves excellent chemical durability, transparency, and devitrification resistance, minimizing glass component elution and foreign matter formation, ensuring safe and effective storage of aqueous-based medicaments.

Implementation Method 1

chemical durability is high so as not to contaminate the aqueous-based medicament for filling

Methodology Applied

Scientific EffectChemical durability:

Implementation Method 2

a method of increasing a content of SiO2 or Al2O3, which is a constituent component of a network structure of the glass

Methodology Applied

Scientific EffectNetwork structure:

Data Source

PatentEP4663614A1Glass for pharmaceutical container, and glass tube for pharmaceutical container

Publication Date: 2025.12.17 NIPPON ELECTRIC GLASS CO LTD

AI summary

A glass for a pharmaceutical container having excellent chemical durability, transparency, and devitrification resistance, and a glass tube for a pharmaceutical container obtained therefrom are provided. A glass for a pharmaceutical container contains, as a glass composition, in mass%, from 65% to 80% of SiO2, from 1% to 10% of Al2O3, from 5% to 20% of B2O3, more than 0% to 0.1% of MoO3, from 0% to 10% of MgO+CaO+SrO+BaO, and from 1% to 20% of Li2O+Na2O+K2O.