Wang Siling, Ye Guanhao, Heng Paul Wan Sia, Ma Mingxin
Department of Pharmaceutics, Shenyang Pharmaceutical University, People's Republic of China.
Chem Pharm Bull (Tokyo). 2008 Jan;56(1):22-7. doi: 10.1248/cpb.56.22.
This study compared the granulation processes for different formulations using a laboratory-scale high shear mixer. The effects of critical process parameters (impeller speed, chopper speed and kneading time) on granule characteristics were evaluated. The characteristics of the granules studied included the size distribution, friability and morphological properties. The flow profiles of the wet mass and material deposition during the process were also studied. The results obtained showed that the effect of the impeller speed was determined by the starting material system. On the other hand, chopper speeds from 1200 to 3600 rpm and kneading times from 120 to 240 s had a consistent influence on all formulations. Moreover, it was found that the toroidal flow pattern of the wet mass could be maintained for a longer period and granules with a good spherical shape were obtained by removing the chopper during the last 120 s of the granulation process. In addition, the use of the pregelatinized starch in the formulation also led to a reduction in the wall adhesion of the material. It was concluded that the effectiveness of high shear wet granulation could be improved by choosing a proper combination of starting material and process parameters and by monitoring the mass motion during the process.
本研究使用实验室规模的高剪切混合器比较了不同配方的制粒过程。评估了关键工艺参数（叶轮速度、切碎机速度和捏合时间）对颗粒特性的影响。所研究颗粒的特性包括尺寸分布、脆碎度和形态特性。还研究了湿物料的流动曲线以及过程中的物料沉积情况。所得结果表明，叶轮速度的影响取决于起始物料体系。另一方面，1200至3600转/分钟的切碎机速度和120至240秒的捏合时间对所有配方都有一致的影响。此外，发现通过在制粒过程的最后120秒去除切碎机，可以使湿物料的环形流动模式保持更长时间，并获得具有良好球形的颗粒。此外，配方中使用预胶化淀粉也导致物料在壁上的附着力降低。得出的结论是，通过选择合适的起始物料和工艺参数组合，并监测过程中的物料运动，可以提高高剪切湿法制粒的效率。
