PECVD-Coated Plastic Syringes for Sterilizable VEGF Packages
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Solution Overview
Problem
Traditional glass pre-filled syringes for intravitreal injections are prone to breakage and degradation, leading to the introduction of particles and impurities into the eye, and plastic syringes are not suitable for sterilization due to gas permeability, which compromises drug stability.
Innovation Solution
A pre-filled pharmaceutical package with a plastic wall coated using Plasma Enhanced Chemical Vapor Deposition (PECVD) techniques, featuring a quadlayer or trilayer coating set that prevents sterilization gases from penetrating, ensuring minimal particulates and maintaining drug stability.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If traditional glass pre-filled syringes are used, then drug delivery is enabled, but breakage and degradation occur leading to particle introduction
Solution Approach 1:
The patent changes the material parameter of the syringe from traditional glass to plastic (cyclic olefin polymer or polypropylene), fundamentally altering the mechanical properties to eliminate breakage and particle generation while maintaining functional integrity for drug delivery
Solution Approach 2:
The patent creates a composite structure by coating plastic syringes with multiple layers including silicon oxide and fluoropolymer coatings, combining the durability of plastic with the surface properties needed for drug compatibility and sterilization resistance
2Object-affected harmful factors
If plastic syringes are used, then particle introduction is reduced, but gas permeability compromises drug stability during sterilization
Solution Approach 1:
The patent applies thin film coatings (silicon oxide layer and fluoropolymer coating) to the plastic syringe surface, creating a barrier that prevents gas penetration while maintaining the underlying plastic's particle-free advantage
Solution Approach 2:
The patent creates a composite structure by coating plastic syringes with multiple layers including silicon oxide and fluoropolymer coatings, combining the durability of plastic with the surface properties needed for drug compatibility and sterilization resistance
3Ease of operation
If silicone coating is applied to glass syringes, then stopper movement is facilitated, but silicone particles are introduced into the drug
Solution Approach 1:
The patent uses a disposable pre-filled syringe system where the entire syringe is discarded after single use, eliminating the need for reusable components that require silicone coating for stopper movement, thereby avoiding silicone particle contamination
Solution Approach 2:
The patent changes the syringe material from glass to plastic, which inherently provides different surface properties that facilitate stopper movement without requiring silicone coating, thus eliminating the source of silicone particle contamination
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 PECVD-coated plastic syringes prevent gas penetration, reducing particle introduction and maintaining drug stability during sterilization, making them suitable for intravitreal injections while minimizing the risk of microbial contamination.
Implementation Method 1
A pre-filled pharmaceutical package with a plastic wall coated using Plasma Enhanced Chemical Vapor Deposition (PECVD) techniques
Data Source
AI summary
A pre-filled pharmaceutical package comprising a liquid formulation of a VEGF-antagonist, for example Ranibizumab, inside the package. A nonlimiting example of the package can be a syringe, cartridge, or vial, made in part or in whole of a thermoplastic polymer, coated on the interior with a tie coating or layer, a barrier coating or layer, a pH protective coating or layer, and optionally a lubricity coating or layer. Optionally, the package further comprises a bag, a blister, a pouch or any other vessel. Stability performance of the VEGF-antagonist packaged in the coated COP vessel comparable to or better than glass was obtained. The said pre-filled pharmaceutical package comprising a liquid formulation of a VEGF-antagonist is suitable for sterilization (such as for surface and/or terminal sterilization) with sterilization gas residuals being minimal and/or lower than required by ISO 10993-7.