Pre-Filled Syringe Resin Barrel for Low-Surfactant Protein Stability
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Solution Overview
Problem
Conventional pre-filled syringes face issues with protein aggregation and production of carcinogenic decomposition products from non-ionic surfactants during long-term storage of protein solution formulations.
Innovation Solution
A pre-filled syringe design using a barrel formed from a resin containing hydrogenated cycloolefin ring-opened polymer or copolymer of cycloolefin and chain olefin, filled with a protein solution formulation having a non-ionic surfactant concentration between 0 mg/mL and 0.05 mg/mL, and a formulation contacting region with a water contact angle of 90° or more, inhibits protein aggregation and reduces decomposition product formation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Stability of the object's composition
If a non-ionic surfactant is included in the protein solution formulation to prevent protein aggregation, then protein stability is improved, but decomposition products are generated during long-term storage
Solution Approach 1:
The patent applies parameter changes by precisely controlling the non-ionic surfactant concentration within the range of 0.003-0.05 mg/mL. This optimized concentration parameter prevents protein aggregation while minimizing surfactant decomposition during long-term storage, thus resolving the contradiction between protein stability and decomposition product generation
Solution Approach 2:
The patent uses a composite material approach by combining the protein solution with a specifically formulated non-ionic surfactant at optimized concentrations, and filling it into a barrel made of hydrogenated cycloolefin resin. This composite system works synergistically to maintain protein stability while reducing decomposition
2Stability of the object's composition
If the non-ionic surfactant concentration is increased to enhance protein stabilization, then protein aggregation is reduced, but the amount of decomposition products increases
Solution Approach 1:
The patent resolves this contradiction through parameter optimization by establishing the non-ionic surfactant concentration within the specific range of 0.003-0.05 mg/mL. This optimized parameter achieves sufficient protein stabilization while minimizing the generation of decomposition products during long-term storage
3Ease of manufacture
If a conventional resin is used for the syringe barrel, then manufacturing is simpler, but protein aggregation occurs during long-term storage
Solution Approach 1:
The patent applies composite materials by using hydrogenated cycloolefin resin for the syringe barrel. This specific resin material provides hydrophobic properties that prevent protein aggregation during long-term storage, while still allowing for practical manufacturing processes
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 effectively prevents protein aggregation and minimizes the production of harmful decomposition products in the syringe even after long-term storage, ensuring stability and safety of the protein solution.
Implementation Method 1
a vessel having a hydrophobic resin selected from 1) a cycloolefin copolymer that is a copolymer of a cycloolefin and an olefin, 2) a cycloolefin ring-opened polymer, and 3) a product obtained through hydrogenation of a cycloolefin ring-opened polymer
Implementation Method 2
The non-ionic surfactant can function as a stabilizer for erythropoietin (i.e., the protein)
Data Source
AI summary
Provided is a pre-filled syringe that can inhibit protein aggregation in a protein solution formulation while also reducing the produced amount of a decomposition product of a non-ionic surfactant after long-term storage. The pre-filled syringe includes: a barrel formed of a resin containing a hydrogenated cycloolefin ring-opened polymer and/or a copolymer of a cycloolefin and a chain olefin; a sealing member sealing a nozzle of the barrel; a gasket housed inside the barrel; and a plunger performing a movement operation of the gasket, and contains a protein solution formulation in a space defined by the sealing member, the gasket, and a region that is part of an inner wall surface of the barrel. The protein solution formulation has a non-ionic surfactant concentration of more than 0 mg/mL and less than 0.05 mg/mL.