The influence of plate design on the properties of pellets produced by extrusion and spheronization.
The influence of plate design on the properties of pellets produced by extrusion and spheronization.
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板设计对挤出和滚圆生产的颗粒性能的影响。
DOI：
10.1016/j.ijpharm.2012.05.050
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发表时间：
2012
影响因子：
5.8
通讯作者：
J. Newton
中科院分区：
文献类型：
--
作者：
H. Michie;F. Podczeck;J. Newton
这项工作的目的是通过挤压和滚圆的方法，使用标准配方生产微丸。采用了三种不同的摩擦片模式(即交叉型、放射型、条纹型)，考察了摩擦片模式对微丸的粒度分布、成形率、形状、机械强度、密度和药物溶出度等物理性能的影响。用筛分挤出机进行挤压，改变筛分尺寸，以确定所产生的挤出物是否会影响颗粒的物理性质。平板载荷也不同。双氯芬酸钠被选为模型药物。挤出物的滚圆化过程中使用的摩擦板的形状影响了颗粒的性能。成品值的差异高达20%，对于其他优化的配方，使用条纹边板在这方面似乎是有利的。然而，尽管这些颗粒的孔隙率较低，但其机械强度降低，这可能是不利的。此外，其他因素，如装入球化机的挤出物的量、球化机内保持恒定的水分含量以及挤出机筛网的大小，对这些结果都有显著的影响。颗粒的唯一物理性质不响应颗粒的制造过程中的各种变化是颗粒形状，其保持为球形。药物的溶出度似乎与微丸的中位数大小有关，并且只受到滚圆过程的改变的轻微影响。
The aim of this work was to produce pellets using a standard formulation by means of extrusion and spheronization. Three different spheroniser friction plate patterns (i.e. cross-hatch, radial, striated edge pattern) have been used in order to investigate whether the plate pattern affects physical properties of the pellets such as pellet size distribution, yield, shape, mechanical strength, density and drug dissolution. Extrusion was performed with a screen extruder and the screen size was varied to determine whether the extrudate produced could affect the physical properties of pellets. The plate load was also varied. Diclofenac sodium was chosen as a model drug. The pattern of the friction plate used in the spheronization of extrudates affected the properties of the pellets. Yield values varied by up to 20%, and for an otherwise optimised formulation the use of a striated edge plate appeared advantageous in this respect. However, these pellets had a reduced mechanical strength despite their lower porosity, which might be disadvantageous. In addition, other factors such as the amount of extrudate loaded into the spheroniser, the maintenance of a constant moisture content within the spheroniser and the size of the extruder screen influenced these findings significantly. The only physical property of the pellets that did not respond to the various changes in the manufacturing process of the pellets is the pellet shape, which remained spherical. The dissolution of the drug appeared to be related to the median pellet size and was only marginally affected by changes in the spheronization process.