Bicarbonate Solution Barrier Container
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Solution Overview
Problem
Conventional bicarbonate solutions in aqueous form face stability issues due to carbon dioxide loss, leading to non-physiological pH values and precipitation formation when stored in semipermeable containers, which affects their efficacy and shelf life.
Innovation Solution
A medicinal product featuring a flexible mono-chamber container with a barrier material that prevents carbon dioxide diffusion, maintaining the pH of the bicarbonate solution within physiological ranges for extended storage periods, thereby enhancing stability and shelf life.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If bicarbonate solution is stored in semipermeable containers, then the container allows gas exchange, but carbon dioxide loss occurs leading to pH increase and precipitation formation
Solution Approach 1:
The container uses a composite material structure consisting of an inner semipermeable membrane layer and an outer barrier layer. The semipermeable membrane allows physiological gas exchange while the barrier layer (made of materials like polyolefin, polyamide, or polyester with specific permeability characteristics) prevents carbon dioxide loss. This composite structure resolves the contradiction by combining the benefits of semipermeability with carbon dioxide retention capability.
2Duration of action of stationary object
If bicarbonate solution is stored for extended periods, then shelf life is extended, but pH drifts to non-physiological values and precipitations form
Solution Approach 1:
The barrier layer in the composite container material prevents carbon dioxide diffusion, thereby maintaining the bicarbonate-c carbon dioxide equilibrium and stabilizing the pH value throughout the extended shelf life. This enables long-term storage (e.g., 24 months or more) while maintaining physiological pH values.
Solution Approach 2:
The barrier layer creates an inert environment regarding gas exchange by being impermeable to carbon dioxide. This prevents external carbon dioxide from entering and internal carbon dioxide from escaping, maintaining a stable chemical environment for the bicarbonate solution during long-term storage.
3Ease of operation
If conventional bicarbonate solutions are used, then bicarbonate is directly available as treatment agent, but stability is compromised due to carbon dioxide loss
Solution Approach 1:
The composite container with its barrier layer enables direct administration of stable bicarbonate solutions. The barrier prevents carbon dioxide loss during storage and transport, ensuring that the bicarbonate remains stable and effective until administration, thus combining direct availability with reliability.
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 ensures a stable, ready-to-use bicarbonate solution with maintained pH values over 12 months, potentially up to 36 months, preventing precipitation and meeting regulatory standards, making it suitable for prolonged storage and use.
Implementation Method 1
the container comprises a first side wall and a second side wall, wherein the first side wall comprises or consists of a barrier material and/or the second side wall comprises or consists of a barrier material... capable of preventing or retarding escape of carbon dioxide from the container
Data Source
AI summary
A medicinal product, in particular a sterile medicinal product, includes a flexible mono-chamber container and an aqueous liquid containing bicarbonate and having a physiological pH value. The container includes a first side wall and a second side wall. The first side wall and the second side wall include a barrier material capable of preventing or retarding escape of carbon dioxide from the container and/or intake of carbon dioxide into the container such that the pH value of the aqueous liquid is maintained or substantially maintained during a shelf life at room temperature of the medicinal product for at least 12 months.