硅化微晶纤维素粉体流动性评价

Flowability evaluation of silicified microcrystalline cellulose

评价硅化微晶纤维素与其同源微晶纤维-微粉硅胶二元混合物的流动性能差异,考察硅化后造成流动性改变的原因,并初步研究其在直接压片工艺中对制剂特性的影响。以粉体流动性不同评价方法考察硅化微晶纤维素与其同源微晶纤维素-微粉硅胶二元混合物的休止角、豪森比、川北方程参数等指标,通过扫描电子显微镜和X线光电子能谱等方法分析引起流动性差异的原因,并选择模型药物考察两种粉体对片剂含量均匀度的影响。硅化微晶纤维素的流动性要略优于相应的物理混合物。硅化微晶纤维素的流动性能优化机制与其相应的物理混合物存在差异,相同条件下,硅化微晶纤维素能更好地控制低剂量药物的含量均匀度。结果表明,硅化微晶纤维素是一种优良的预混辅料,对促进和提高固体制剂工业水平有重要意义。

The flowability of silicified microcrystalline cellulose was compared with a mixture of standard grade of microcrystalline cellulose and silicon dioxide in order to elucidate the flowability changes of materials due to the silicification process and effects on the preparation characteristics in the direct compression process. The flow- ability, angle of repose, Hausner ratio and parameters in Kawakita equation were determined. Flowability differ- ences were analyzed using scanning electron microscopy and X-ray microanalysis. Also, model drug was selected to investigate the content uniformity under desirable compressing performance. The flowability of silicified micro- crystalline cellulose was better than the corresponding physical mixture, and the mechanism of flowability improvement was different. Silicified microcrystalline cellulose had better ability to improve the content uniformity of low dosage formulations. In conclusion, silicified microcrystalline cellulose is an excellent co-processed excipient, helpful to promote and improve the tablet manufacturing level.