Emulsion Homogenization Apparatus With Under-Blade Droplet Injection

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Solution Overview

Problem

Conventional methods for manufacturing sustained-release microspheres face challenges in homogeneously mixing high-viscosity polymer oil and aqueous solutions, leading to reduced drug encapsulation efficiency due to layer separation and increased viscosity, which results in inefficient emulsification.

Innovation Solution

An emulsion homogenization apparatus that injects the main ingredient aqueous solution in the form of droplets under stirring blades while stirring the polymer oil solution, utilizing a medicinal fluid injection part and controlled stirring speeds to disperse and homogenize the W1/O emulsion.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Manufacturing precision

If the rotation speed and stirring time of the conventional stirring apparatus are increased to achieve homogeneous mixing of high-viscosity polymer oil solution and aqueous solution, then mixing homogeneity is improved, but heat generation causes the solvent (methylene chloride) to boil and volatilize, changing the concentration of the polymer oil solution and reducing drug encapsulation efficiency

Engineering Contradiction:
Improvemixing homogeneityVSAvoiddrug encapsulation efficiency
Core Design Contradiction:
Manufacturing precisionVSReliability

Solution Approach 1:

The patent replaces the conventional mechanical stirring system with an ultrasonic homogenization system. The ultrasonic waves generate cavitation bubbles that collapse violently, creating intense local mixing without requiring high mechanical shear forces. This substitution of mechanical stirring with ultrasonic cavitation-based mixing resolves the contradiction by achieving homogeneous mixing without excessive heat generation that would cause solvent volatilization and concentration changes.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The patent changes the physical parameters of the mixing process by using ultrasonic frequency vibrations instead of mechanical rotation. The ultrasonic homogenizer operates at high frequency (typically 20 kHz or higher) with low amplitude, creating cavitation effects that mix the high-viscosity polymer oil solution and aqueous solution homogeneously without generating excessive heat, thus maintaining solvent stability and drug encapsulation efficiency.

Inventive Principle:
Principle #35Parameter changes

2Productivity

If the volume of the mixture of polymer oil phase solution and main ingredient aqueous solution is increased for practical production, then productivity is improved, but mixing homogeneity decreases due to high viscosity, making emulsification difficult and reducing drug encapsulation efficiency

Engineering Contradiction:
Improvevolume of mixtureVSAvoidmixing homogeneity
Core Design Contradiction:
ProductivityVSManufacturing precision

Solution Approach 1:

The ultrasonic homogenization system replaces mechanical stirring, enabling effective mixing of large volumes of high-viscosity mixture. The cavitation effect penetrates throughout the entire volume, creating uniform distribution of aqueous droplets in the oil phase even at scale-up volumes, thus maintaining mixing homogeneity while increasing productivity.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The ultrasonic homogenizer creates dynamic cavitation bubbles that form and collapse rapidly throughout the mixture volume. This dynamic process generates intense local turbulence and shear forces that effectively mix high-viscosity materials at any scale, allowing the system to maintain mixing homogeneity while processing larger volumes for practical production.

Inventive Principle:
Principle #15Dynamics

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 apparatus significantly enhances drug encapsulation rate by approximately twice compared to conventional methods, achieving improved homogeneity and reduced particle size in the microspheres.

Implementation Method 1

an ultrasonic homogenizer that ultrasonic-waves-cavitates a W1/O emulsion

Methodology Applied
Scientific EffectUltrasonic cavitation: Cavitation

Implementation Method 2

a stirring unit including a stirring shaft and stirring blades mounted on the stirring shaft, the stirring blades being rotatably provided within the stirring container

Methodology Applied
Scientific EffectMechanical stirring: Stirring

Implementation Method 3

a medicinal fluid injection part having a discharge port through which a main ingredient aqueous solution including a drug is discharged in the form of droplets

Methodology Applied
Scientific EffectFluid discharge:

Data Source

PatentEP4631610A1Emulsion homogenization apparatus and method for manufacturing sustained-release microspheres having improved drug encapsulation rate
Publication Date: 2025.10.15 DAEWOONG PHARM CO LTD
  • EP4631610A1 patent drawingFigure 1
  • EP4631610A1 patent drawingFigure 2
  • EP4631610A1 patent drawingFigure 3

AI summary

An emulsion homogenization apparatus, according to an embodiment of the present invention, comprises: a stirring container; a stirring unit provided with a stirring shaft and stirring blades and installed in the stirring container so as to be able to rotate; and a medicinal fluid injection part having a discharge port through which a main ingredient aqueous solution containing a drug is discharged in the form of droplets, the discharge port being installed in the stirring container, between the bottom surface of the stirring container and the stirring blades, so as to face the stirring blades.