Delamination-Resistant Pharmaceutical Glass Containers
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Conventional glass pharmaceutical containers suffer from mechanical fragility, delamination issues, and chemical instability, leading to safety concerns and product degradation, which compromises the efficacy and stability of active pharmaceutical ingredients.
Innovation Solution
A delamination-resistant glass composition with specific alkali and alkaline earth oxide ratios, ion exchange strengthening, and a compressive stress layer to enhance mechanical durability and chemical stability, preventing silica-rich flake shedding and maintaining the integrity of pharmaceutical compositions.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If glass is used for pharmaceutical packaging, then chemical durability and hermeticity are improved, but mechanical strength and resistance to breakage deteriorate
Solution Approach 1:
The patent applies parameter changes by modifying the glass composition parameters (specific ratios of SiO2, B2O3, Al2O3, Na2O, K2O, CaO, and MgO) to achieve optimal balance between chemical durability and mechanical strength. The glass composition is specifically engineered with SiO2 (65-75 wt%), B2O3 (10-20 wt%), Al2O3 (5-15 wt%), and controlled amounts of alkali and alkaline earth oxides to create a material that resists both chemical degradation and mechanical breakage.
Solution Approach 2:
The patent creates a composite glass material that combines multiple oxide components in specific proportions to achieve properties that individual components cannot provide alone. The composite nature of the glass, incorporating network formers (SiO2, B2O3), network modifiers (Na2O, K2O, CaO, MgO), and intermediate oxides (Al2O3), enables simultaneous improvement of chemical durability and mechanical strength.
2Reliability
If glass composition is optimized for chemical durability, then resistance to pharmaceutical solution degradation is improved, but susceptibility to delamination worsens
Solution Approach 1:
The patent applies parameter changes by precisely controlling the composition parameters of the glass, particularly the ratios of alkali oxides (Na2O, K2O) to alumina and the amounts of alkaline earth oxides (CaO, MgO). The glass composition is formulated with specific ranges: SiO2 (65-75 wt%), B2O3 (10-20 wt%), Al2O3 (5-15 wt%), Na2O (5-15 wt%), K2O (0-5 wt%), CaO (0-5 wt%), and MgO (0-5 wt%). These parameter optimizations reduce delamination while maintaining chemical durability.
Solution Approach 2:
The patent applies local quality by creating a glass composition with differentiated functional regions at the molecular level. The network structure is designed with B2O3-rich regions providing chemical durability and SiO2-Al2O3 regions providing structural integrity and delamination resistance. The controlled distribution of alkali and alkaline earth oxides creates local modifications that prevent delamination while maintaining overall chemical durability.
3Strength
If glass is thermally tempered to improve mechanical strength, then resistance to breakage is improved, but applicability to complex geometries and thin walls deteriorates
Solution Approach 1:
The patent replaces the mechanical thermal tempering system with a chemical strengthening system. Instead of using thermal gradients to induce compressive stress, the glass composition is chemically engineered to inherently provide mechanical strength through its molecular structure. The high SiO2 content (65-75 wt%) and optimized B2O3-Al2O3 network create a naturally stronger glass that can be formed into complex geometries and thin walls without requiring thermal tempering.
Solution Approach 2:
The patent applies parameter changes by modifying the glass composition parameters to achieve lower thermal expansion coefficient and higher chemical durability. The glass is formulated with specific oxide ratios that enable it to withstand complex forming processes without thermal tempering. The composition parameters (SiO2: 65-75 wt%, B2O3: 10-20 wt%, Al2O3: 5-15 wt%) are optimized to provide inherent mechanical strength suitable for complex geometries and thin-walled pharmaceutical containers.
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 provides a robust and chemically stable glass container that minimizes delamination, maintains the stability and efficacy of pharmaceuticals, and reduces the risk of product recalls by ensuring the integrity of active ingredients during storage and delivery.
Implementation Method 1
chemical tempering also strengthens glass by the introduction of surface compressive stress. The stress is introduced by submerging the article in a molten salt bath. As ions from the glass are replaced by larger ions from the molten salt, a compressive stress is induced in the surface of the glass
Implementation Method 2
glasses having suitable chemical durability include those glass compositions within the ASTM standard 'Type 1B' glass compositions which have a proven history of chemical durability
Data Source
Figure 1~2
Figure 3~4
Figure 5~6
AI summary
The present invention is based, at least in part, on the identification of a pharmaceutical container formed, at least in part, of a glass composition which exhibits a reduced propensity to delaminate, i.e., a reduced propensity to shed glass particulates. As a result, the presently claimed containers are particularly suited for storage of pharmaceutical compositions and, specifically, a pharmaceutical solution comprising a pharmaceutically active ingredient, for example, FORTEO® (recombinant human teriparatide), DULAGLUTIDE® (LY2189265), recombinant insulin glargine, RAMUCIRUMAB® (IMC-1121B), SOLANEZUMAB® (LY2062430), IXEKIZUMAB® (LY2439821), TABALUMAB® (LY2127399), NECITUMUMAB® (IMC-11F8), or CIXUTUMUMAB® (IMC-A12).