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03
2026
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04
Particle Size Control of Pharmaceutical-Grade Silicon Dioxide: Key Impact from Production Process to Preparation Efficiency
Particle size is the core performance indicator of pharmaceutical-grade silicon dioxide, which directly affects its glidant and disintegration efficiency in preparations, and needs to be precisely controlled through the production process.
Particle size is the core performance indicator of pharmaceutical-grade silicon dioxide, which directly affects its glidant and disintegration efficiency in preparations, and needs to be precisely controlled through the production process. The Chinese Pharmacopoeia requires that the proportion of medicinal silicon dioxide passing through the No.7 sieve (125μm) is not less than 85%, but the requirements for particle size of different preparations are significantly different: the particle size of excipients for tablets should be controlled at 10-50μm to ensure glidant and mixing uniformity; the particle size of excipients for capsules should be 5-20μm to avoid wear of the capsule shell.
In production, the particle size is controlled through the "crushing-classification" linkage process: jet crushing technology is adopted to avoid mechanical pollution, and components with different particle sizes are separated through a cyclone classifier, so that the particle size distribution span (D90/D10) is ≤3.0, which is better than the industry average (≤4.5). Particle size is negatively correlated with specific surface area. The specific surface area of 10μm particles is about 350m²/g, and that of 50μm particles is about 180m²/g. Functional adaptation can be achieved by adjusting the particle size.
The Company has significant quality control advantages: it uses a laser particle size analyzer to monitor the production process in real time, and the particle size detection data of each batch of products reaches more than 100 groups, ensuring that the difference between batches is less than 5%. For poorly soluble drug preparations, it has developed "ultra-fine particle size type" products (particle size 5-10μm), which can increase the drug dissolution rate by 15%-20% and help pharmaceutical companies solve preparation problems.
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