Borosilicate Glass Ion Release Reduction
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Solution Overview
Problem
Current borosilicate glasses used in the pharmaceutical sector have high ion release when in contact with aqueous medicaments, leading to potential health risks and instability of medicaments due to excessive alkali metal and alkaline earth metal ion extraction, which is not adequately addressed by existing compositions.
Innovation Solution
A borosilicate glass composition with a specific range of potassium oxide content (0.1-0.9% by weight) is developed, which reduces total alkali metal and ion release, enhancing hydrolytic resistance and minimizing health risks, while maintaining processability and chemical resistance.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If conventional borosilicate glass compositions are used, then chemical resistance is maintained, but ion release to aqueous medicaments is excessive
Solution Approach 1:
The patent applies parameter changes by precisely controlling the potassium oxide content within 0.1-0.9% by weight and aluminum oxide within 5.5-8% by weight. This specific parameter range optimization resolves the contradiction by achieving both low ion release (improving harmful factors) and high hydrolytic resistance (improving reliability), unlike conventional compositions that do not specify these narrow ranges.
Solution Approach 2:
The patent creates an optimized composite glass material by combining specific ratios of potassium oxide (0.1-0.9%), aluminum oxide (5.5-8%), silicon dioxide (71-77%), and boron oxide (9-12%). This composite approach resolves the contradiction by synergistically combining multiple components in precise proportions to achieve both low ion release and high hydrolytic resistance simultaneously.
2Ease of manufacture
If potassium oxide content is increased to improve glass properties, then processability improves, but total alkali metal ion release increases
Solution Approach 1:
The patent resolves this contradiction by establishing an optimal parameter range for potassium oxide (0.1-0.9% by weight). This specific range provides sufficient processability benefits while limiting alkali metal ion release, whereas conventional compositions use broader or higher ranges that increase ion release.
Solution Approach 2:
The patent applies local quality by strategically positioning potassium oxide at specific concentration levels (0.1-0.9%) within the glass composition. This localized optimization ensures potassium provides its beneficial effects on processability while its concentration is controlled to minimize harmful ion release into medicaments.
3Object-affected harmful factors
If aluminum oxide content is increased to reduce ion release, then hydrolytic resistance improves, but manufacturing complexity increases
Solution Approach 1:
The patent resolves this contradiction by specifying a precise parameter range for aluminum oxide (5.5-8% by weight). This optimized range achieves effective ion release reduction and improved hydrolytic resistance while avoiding excessive manufacturing complexity that would result from broader or more extreme compositional ranges.
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 significantly lower ion release, particularly reducing aluminum ion release, thereby minimizing health risks and ensuring the stability of aqueous medicaments, making it suitable for pharmaceutical primary packaging.
Implementation Method 1
Borosilicate glass having improved hydrolytic resistance for preferred use in the pharmaceutical sector
Data Source
AI summary
Borosilicate glasses, preferably for use in the pharmaceutical sector, are provided. The borosilicate glasses are outstandingly suitable for the use as pharmaceutical primary packaging, such as phials or ampoules, since the aqueous or water-containing medicaments kept in the containers do not attack the glass significantly, and so the glass releases no, or only few, ions. The borosilicate glasses have the following composition in % by weight or consist thereof:SiO271-77;B2O39-12;Al2O35.5-8;Na2O6-8;K2O0.1-0.9;Li2O0-0.3;CaO0-1.5;BaO0-1;F0-0.3;Cl-0-0.3; andMgO + CaO + BaO + SrO 0-2.