Chevalier E, Viana M, Pouget C, Chulia D
GEFSoD EA 2631, Faculté de Pharmacie, Laboratoire de Pharmacie Galénique, Limoges Cedex, France.
Pharm Dev Technol. 2007;12(2):133-44. doi: 10.1080/10837450701212461.
The aim of the study was to prepare porous pellets several hundred micrometers in diameter into or onto which drug substances could be embedded. Wet granulation was carried out on a powder mix of alpha-lactose and polyvinylpyrrolidone in a Mi-Pro high-shear granulator. The process parameters were investigated to point out their influence on pellet physical properties. The reference conditions of granulation that gave the most satisfactory pellets in size and shape were determined by adjusting the volume and the distribution rate of water. Increasing impeller speed resulted in an increase in granule size and granulation yield and in a decrease in proportion of fines. The granules showed easy flowing for all granulation conditions. Adjusting process parameters enabled control of size, shape, surface area, and porosity of the granules and thus the design of ready to use granules to which drug substances could be associated by deposition or inclusion.
本研究的目的是制备直径为几百微米的多孔微丸，药物可包埋于其中或附着于其表面。在Mi-Pro高剪切制粒机中，对α-乳糖和聚乙烯吡咯烷酮的粉末混合物进行湿法制粒。研究了工艺参数以指出它们对微丸物理性质的影响。通过调节水的体积和分布速率，确定了在尺寸和形状方面能得到最令人满意微丸的制粒参考条件。提高搅拌桨速度会导致颗粒尺寸增大、制粒收率提高以及细粉比例降低。在所有制粒条件下，颗粒均表现出良好的流动性。调节工艺参数能够控制颗粒的尺寸、形状、表面积和孔隙率，从而设计出可通过沉积或包合与药物结合的即用型颗粒。
