Continuous Microsphere Preparation via Simultaneous Emulsion Injection
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Solution Overview
Problem
Conventional discontinuous processes for preparing microspheres face challenges in achieving uniform particle size distribution and reproducibility, especially when scaling up from laboratory to production levels, due to difficulties in controlling particle size and shape, and require high energy input which becomes impractical as production volume increases.
Innovation Solution
A continuous process involving the simultaneous injection of first and second emulsions, followed by high-pressure application to form microspheres instantly, allowing for precise control of particle size and distribution, and enabling mass production of uniform microspheres from nano to micro sizes.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If a discontinuous process is used to prepare microspheres by injecting first emulsion into a second solution, then particle formation can be achieved, but the particle size distribution becomes very wide (1 to 400 μm) and reproducibility is poor
Solution Approach 1:
The patent applies continuous injection of both first and second emulsions through injection nozzles, replacing the traditional discontinuous batch process. This continuous action ensures uniform mixing and consistent particle formation, achieving narrow particle size distribution (0.1 to 10 μm) while maintaining scalability for mass production without the wide size variation (1 to 400 μm) seen in discontinuous processes.
2Manufacturing precision
If high energy input methods (high-speed circulation, homogenization, ultrasonication) are used to control fast curing of particles, then particle size can be controlled, but the energy requirement becomes impractical when production volume increases
Solution Approach 1:
The patent controls particle size by adjusting process parameters including injection rates of the first and second emulsions, composition ratios, and applied pressure (0.1 to 10 MPa), rather than relying on high-energy input methods. This parameter-based control achieves uniform particle sizes (0.1 to 10 μm) without the excessive energy requirements of homogenization or ultrasonication, making the process scalable to mass production.
3Productivity
If the volume of the second emulsion is increased to match production scale, then mass production can be achieved, but the fast curing of particles becomes more difficult to control and particle uniformity decreases
Solution Approach 1:
The patent maintains particle uniformity at scale by continuously injecting both emulsions simultaneously through nozzles, ensuring consistent mixing ratios and immediate uniform distribution throughout the reaction volume. This continuous co-injection method prevents the curing control problems that occur when simply scaling up batch volumes, maintaining narrow particle size distribution (0.1 to 10 μm) regardless of production volume.
Solution Approach 2:
The patent prepares both first and second emulsions in advance with optimized compositions and injection rates before the actual particle formation process. This preliminary preparation ensures that when the emulsions are injected together, the curing process proceeds uniformly throughout the entire volume, preventing the loss of particle uniformity that typically occurs during scale-up of traditional batch processes.
4Manufacturing precision
If multiple parameters (injection time, temperature, volume ratio, concentration, location, circulation, evaporation time) are adjusted to control particle formation, then particle characteristics can be optimized, but the process complexity increases and scaling becomes very difficult
Solution Approach 1:
The patent optimizes particle characteristics by systematically adjusting key parameters including injection rates of first and second emulsions, temperature (0 to 50°C), pressure (0.1 to 10 MPa), and composition ratios. This controlled parameter adjustment achieves desired particle properties (size 0.1 to 10 μm, spherical shape, narrow distribution) while maintaining process simplicity and scalability, avoiding the complexity of controlling numerous independent parameters in traditional batch 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
This approach enables the reproducible production of microspheres with consistent particle sizes, improving uniformity and encapsulation efficiency, and allows for scalable production without the need for significant changes in process conditions, even at increased volumes, by adjusting pressure to achieve target particle sizes.
Implementation Method 1
dissolving a water-soluble drug in the aqueous phase to form a first emulsion, and injecting the first emulsion into a second solution of poly(vinyl alcohol) (PVA) to form microspheres
Implementation Method 2
applying high pressure to the microspheres formed
Data Source
AI summary
The present invention relates to a continuous process for preparing microspheres and microspheres prepared thereby, and in particular, a process for preparing microspheres comprising steps of injecting a first emulsion and a second emulsion at the same time to form microspheres instantaneously, applying high pressure to the microspheres formed, and injecting the microspheres into an agitator, wherein the steps can be carried out continuously, and microspheres prepared thereby.When microspheres are prepared using the method of the present invention, scale variables, which have been the biggest disadvantage in existing preparation methods of microspheres, can be significantly reduced, drug encapsulation efficiency can be improved, and small and uniform particles can be obtained.