Biodegradable Microsphere Solvent Extraction Stability
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Solution Overview
Problem
Conventional methods for producing biodegradable polymer microspheres often result in high residual solvent levels, which compromise the stability and safety of the final product due to the use of toxic solvents like dichloromethane and chloroform, leading to decomposition during storage.
Innovation Solution
A method involving the formation of a biodegradable polymer solution in an organic solvent, followed by uniform mixing with a surfactant-containing aqueous solution to create an emulsion, where the organic solvent is extracted and replaced with a new continuous phase, minimizing residual solvent and maintaining microsphere shape and stability.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Stability of the object's composition
If toxic solvents like dichloromethane or chloroform are used to dissolve biodegradable polymers and active agents, then homogeneous dissolution is achieved, but residual solvent levels increase causing toxicity and decomposition during storage
Solution Approach 1:
The patent changes the solvent system from toxic organic solvents (dichloromethane, chloroform) to safer alternative solvents that achieve homogeneous dissolution without leaving harmful residues. This parameter change in solvent composition resolves the contradiction by maintaining dissolution effectiveness while eliminating toxicity and improving storage stability.
Solution Approach 2:
The patent extracts and removes residual organic solvents from the microsphere formulation through purification processes. By taking out the harmful residual solvents after microsphere formation, the invention eliminates the toxic effects while preserving the microsphere structure and drug encapsulation.
2Stability of the object's composition
If organic solvent mixtures are used to dissolve biodegradable polymer and active agent simultaneously, then homogeneous solution is formed, but insufficient solvent removal leads to adverse effects on product stability
Solution Approach 1:
The patent implements extraction processes to remove organic solvents from the microsphere formulation. By extracting the harmful organic solvents after the dissolution and microsphere formation steps, the invention reduces residual solvent amounts while maintaining product stability and preventing decomposition during storage.
Solution Approach 2:
The patent changes the solvent removal parameters by using alternative removal methods or conditions that more effectively eliminate organic solvents. This may include changes in temperature, pressure, or using alternative solvents that are more easily removed, thereby reducing residual solvent amounts and improving product stability.
3Object-affected harmful factors
If conventional solvent extraction and evaporation methods are used, then organic solvent is removed from dispersed phase, but morphological changes and molecular weight reduction occur
Solution Approach 1:
The patent changes the parameters of the solvent removal process by using milder conditions or alternative methods that prevent morphological changes and molecular weight reduction. This may involve controlling temperature, pressure, or time parameters during solvent removal to maintain microsphere integrity while still achieving adequate solvent elimination.
Solution Approach 2:
The patent uses an intermediary substance or method during the solvent removal process to protect the microsphere structure. This intermediary may be a protective coating, a stabilizing agent, or a controlled environment that prevents direct damage to the microsphere morphology and polymer molecular weight during solvent extraction and evaporation.
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
This approach effectively reduces residual solvent levels, enhances storage stability, and maintains the structural integrity of biodegradable polymer microspheres by efficiently removing organic solvents, ensuring safety and prolonged shelf life.
Implementation Method 1
extracting and evaporating the organic solvent from the dispersed phase in the emulsion of step (b) to the continuous phase
Implementation Method 2
extracting and evaporating the organic solvent from the dispersed phase in the emulsion of step (b) to the continuous phase
Data Source
AI summary
The present invention relates to a method for producing biodegradable microspheres having improved safety and storage stability, and a method for producing the same. The present invention provides a method for preparing said biodegradable microspheres while minimizing the morphological changes of microspheres and significantly reducing residual solvents.