Ion-Exchange Syringe Assembly for Comfortable pH-Adjusted Injection
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Solution Overview
Problem
Subcutaneous administration of protein-based drugs, such as Kineret ®< (anakinra), often causes discomfort and pain due to non-physiological pH, which existing solutions fail to adequately address.
Innovation Solution
A pre-filled syringe with an ion exchange material that adjusts the pH of the drug from a non-physiological to a physiological range just prior to injection, using materials like zeolite to exchange ions and raise the pH from 3-6.6 to 6.6-8.0.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Duration of action of stationary object
If the pharmaceutically acceptable solution is stored at non-physiological pH (3-6.6), then the shelf life is extended, but the patient experiences discomfort and pain during injection
Solution Approach 1:
The ion exchange material is pre-loaded into the syringe barrel before use, positioned to contact the solution only during injection. This preliminary preparation allows the pH adjustment function to be ready but inactive during storage, extending shelf life while ensuring comfort is provided when needed during administration
Solution Approach 2:
The ion exchange material acts as an intermediary substance between the non-physiological pH solution and the patient's body. It mediates the pH adjustment process by exchanging ions with the solution, transforming the harmful non-physiological pH into a comfortable physiological pH range (6.6-8.0) at the point of injection
2Object-affected harmful factors
If the pH of the solution is adjusted to physiological range before storage, then patient comfort is improved, but the shelf life is reduced
Solution Approach 1:
Instead of adjusting pH before storage, the ion exchange material is preliminarily prepared in the syringe but remains inactive during storage. The pH adjustment action is delayed until the moment of injection, allowing the solution to maintain stable non-physiological pH during storage for extended shelf life while ensuring comfort during administration
Solution Approach 2:
The system transitions from a static pH state during storage to a dynamic pH adjustment state during injection. The ion exchange material remains dormant during storage, then becomes active when the solution contacts it during ejection, dynamically adapting the pH to physiological levels only when needed for patient comfort
3Object-affected harmful factors
If ion exchange material is placed in contact with the solution during storage, then pH is adjusted, but the solution stability is compromised
Solution Approach 1:
The ion exchange material serves as an intermediary that only interacts with the solution during the brief injection process, not during storage. This controlled interaction ensures solution stability is maintained during storage while still providing pH adjustment benefits during administration through the intermediary's selective ion exchange activity
Solution Approach 2:
The ion exchange material is preliminarily positioned in the syringe but kept separated from the solution during storage. This preliminary placement without contact preserves solution stability during storage, while enabling pH adjustment to occur only during the controlled ejection phase when the material and solution come into contact
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 syringe effectively alleviates discomfort and pain by adjusting the pH during injection, maintaining shelf-life benefits of storing at non-physiological pH while ensuring comfort during administration.
Implementation Method 1
an ion exchange material provided such that the pharmaceutically acceptable solution, when contained within the barrel, does not contact the ion exchange material, wherein the ion exchange material is provided at a position to allow contact with the pharmaceutically acceptable solution upon ejection of the pharmaceutically acceptable solution from the barrel via the outlet
Data Source
Figure 1a~1b
Figure 2a~2b
Figure 3a~3b
AI summary
A pre-filled syringe is disclosed, comprising a barrel and a plunger, the barrel having an outlet, the barrel containing a pharmaceutically acceptable solution having a non-physiological pH, wherein the syringe further comprises an ion exchange material. The ion exchange material is provided at a position to allow contact with the pharmaceutically acceptable solution upon ejection of the pharmaceutically acceptable solution from the barrel via the outlet. The ion exchange material is capable of adjusting the pH of the solution from a non-physiological pH, at which the pharmaceutically acceptable solution is stored in order to ensure acceptable shelf life, to a more physiological pH at which the discomfort and/or pain experienced during injection may be alleviated.