Sustained-Release Composition Emulsion Stabilization
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Solution Overview
Problem
Existing methods for producing sustained-release compositions with biodegradable polymers face challenges in stabilizing W/O type emulsions, leading to instability and inefficiencies in drug delivery.
Innovation Solution
A process involving mixing an aqueous solution with a physiologically active substance and a biodegradable polymer, using an excess amount of acid or base to achieve a stable W/O type emulsion, where the acid or base is added in a molar amount of 1.5 or more times that of the substance, and the mixture is then dried to form a sustained-release composition.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional methods are used to produce sustained-release compositions with biodegradable polymers, then the production process can be completed, but the W/O type emulsion becomes unstable
Solution Approach 1:
The invention changes the pH parameter of the aqueous solution by adding acid or base to create excess H+ or OH- ions. This parameter change stabilizes the emulsion by preventing polymer precipitation while maintaining production efficiency. The pH adjustment is a fundamental parameter change that resolves the contradiction between emulsion stability and productivity.
Solution Approach 2:
The invention introduces acid or base as an intermediary substance that mediates between the physiologically active substance and the biodegradable polymer. This intermediary prevents direct harmful interactions that would cause emulsion instability, allowing the emulsion to remain stable throughout the production process while maintaining high productivity.
2Ease of operation
If the mixture viscosity is reduced to 3,000 cp or less for better processing, then the ease of operation improves, but the emulsion stability may be compromised
Solution Approach 1:
The invention uses pH parameter changes to control both viscosity and stability simultaneously. By adjusting the acid or base concentration, the mixture viscosity is reduced to 3,000 cp or less for easy processing, while the same pH condition stabilizes the emulsion. This dual effect resolves the contradiction between ease of operation and emulsion stability.
3Stability of the object's composition
If a stoichiometric amount of acid or base is used relative to the physiologically active substance, then the chemical balance is maintained, but the emulsion becomes unstable
Solution Approach 1:
The invention applies excessive action by using acid or base in amounts exceeding the stoichiometric requirement. Specifically, the acid or base is used in 1.1 to 5 times the molar amount of the physiologically active substance. This excessive action creates a buffer environment that stabilizes the emulsion composition while the simple ratio calculation keeps the process complexity low.
4Reliability
If the acid or base amount is increased to stabilize the emulsion, then the emulsion stability improves, but the amount of additional chemical substances increases
Solution Approach 1:
The invention optimizes the excessive action to the minimum required level. The acid or base is used in 1.1 to 5 times the molar amount of the physiologically active substance, with the lower end of this range (1.1-2 times) being sufficient for most applications. This provides the necessary emulsion stability while minimizing the quantity of additional chemical substances added to the system.
Data Source
AI summary
A process for producing a sustained-release composition which comprises mixing an aqueous solution containing a physiologically active substance and an acid or base in a molar amount of 1.5 or more times that of the physiologically active substance with a solution of a biodegradable polymer and then drying the mixture is provided.