Flaky Sodium Stearyl Fumarate Recrystallization for Uniform Powder
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Existing refining methods for sodium stearyl fumarate result in poor particle size uniformity, wide particle size distribution, destruction of flaky structure, and easy-caking, making it inconvenient for formulation use.
Innovation Solution
A recrystallization method involving heating in ethanol, filtering, adding crystal seeds, and controlled cooling to achieve a homogeneous pharmaceutical excipient with a flaky structure, using ethanol concentrations of 10% to 70% and controlled cooling rates to ensure uniform particle size and integrity.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If beating and washing with organic solvent followed by milling is used to refine sodium stearyl fumarate, then impurities are removed, but particle size uniformity deteriorates and flaky structure is destroyed
Solution Approach 1:
The patent applies phase transition by dissolving sodium stearyl fumarate in hot ethanol and then cooling the solution to induce controlled crystallization. This phase change process naturally forms uniform flaky crystals without mechanical destruction, resolving the contradiction between removing impurities and preserving structure.
Solution Approach 2:
The patent changes physical parameters (temperature, solvent concentration) to control the crystallization process. By adjusting ethanol concentration to 10-70% and controlling cooling rate, uniform flaky particles with narrow size distribution are obtained, improving both particle size uniformity and structural integrity.
2Manufacturing precision
If milling is used to control particle size, then particle size range is reduced, but flaky structure is seriously destroyed
Solution Approach 1:
Instead of mechanical milling, the patent uses controlled phase transition during cooling crystallization to form particles of desired size. The slow cooling process allows uniform crystal growth, achieving narrow particle size distribution while preserving the natural flaky structure.
3Ease of manufacture
If conventional refining method is used, then processing is simple, but product cakes after long period
Solution Approach 1:
The patent changes the physical state and morphology of the product through controlled crystallization. The resulting uniform flaky structure with narrow size distribution has improved flow properties and reduced caking tendency, enhancing long-term stability while maintaining reasonable processing complexity.
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 method produces sodium stearyl fumarate with a narrow particle size range of 5-15 μm, intact flaky structure, and improved uniformity, preventing caking and enhancing formulation convenience.
Implementation Method 1
heating and dissolving the sodium stearyl fumarate to be treated in ethanol
Implementation Method 2
cooling down the obtained solution with circulating water from 10 to 50° C., conducting recrystallization of the sodium stearyl fumarate during the cooling down
Implementation Method 3
adding crystal seeds for recrystallization
Data Source
AI summary
The present disclosure discloses a homogeneous pharmaceutical excipient sodium stearyl fumarate with flaky structure and preparation method thereof, which belongs to the field of pharmaceutical excipient refining technology. The method of the present disclosure includes: heating and dissolving sodium stearyl fumarate to be treated in an ethanol solution and filtering to remove impurities, then adding crystal seeds for recrystallization. The crystallized sodium stearyl fumarate with flaky structure has narrow particle size distribution, average particle size of 5-15 μm, intact flaky structure, good uniformity and purity up to 99.6% or more, and it is not easy-caking and can keep the powder state for a long time.