Delamination-Resistant Pharmaceutical Glass Containers
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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
Development of a delamination-resistant glass composition with a compressive stress greater than or equal to 150 MPa and a depth of layer greater than 10 µm, specifically designed for pharmaceutical containers like those holding PREVNAR 13 vaccine, using an alkali aluminosilicate glass formulation without boron and phosphorous, enhancing chemical and mechanical durability through ion exchange strengthening.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Stability of the object's composition
If glass is used for pharmaceutical packaging to provide hermeticity and chemical durability, then chemical stability is improved, but mechanical strength deteriorates
Solution Approach 1:
The glass composition parameters are changed by adjusting the ratio of network formers (SiO2, B2O3) to network modifiers (Na2O, CaO, MgO) and adding specific amounts of Al2O3 and P2O5. This optimization allows the glass to achieve both chemical durability and mechanical strength suitable for pharmaceutical packaging.
Solution Approach 2:
The patent creates a composite glass system combining multiple oxides (SiO2, B2O3, Na2O, CaO, MgO, Al2O3, P2O5) in specific proportions. This composite formulation synergistically provides both chemical resistance to pharmaceutical contents and mechanical strength to prevent breakage.
2Reliability
If glass composition is optimized for chemical durability, then delamination resistance is improved, but manufacturing complexity increases
Solution Approach 1:
The glass composition parameters are optimized by controlling the content ranges of specific oxides: SiO2 (50-70 wt%), B2O3 (10-30 wt%), Na2O (5-15 wt%), CaO (5-15 wt%), MgO (2-10 wt%), Al2O3 (2-10 wt%), and P2O5 (0.1-5 wt%). These parameter optimizations reduce delamination while maintaining manufacturability.
3Ease of manufacture
If glass thickness is reduced to enable complex geometries, then ease of manufacture is improved, but mechanical strength deteriorates
Solution Approach 1:
The glass composition is formulated with optimal ratios of network formers and modifiers that enhance strength-to-thickness ratio. This allows thin-walled complex geometries to maintain adequate mechanical strength for pharmaceutical packaging applications.
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 increased stability, product integrity, and efficacy of pharmaceutical compositions by preventing delamination and mechanical failure, ensuring the safety and effectiveness of the active ingredients during storage and delivery.
Implementation Method 1
enhancing chemical and mechanical durability through ion exchange strengthening
Data Source
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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, PREVNAR 13 (Pneumococcal 13-valent Conjugate Vaccine).