Thoma K, Ziegler I
Department of Pharmaceutical Technology, Ludwig-Maximilians University Munich, Munich, Germany.
Drug Dev Ind Pharm. 1998 May;24(5):401-11. doi: 10.3109/03639049809085637.
Three different extruders (the Alexanderwerk gravity feed roll extruder, the Gabler axial, single-screw extruder, and the NICA radial-screw extruder) were compared for their suitability for different placebo formulations and for fenoldopam pellets. A fourth extruder, the experimental ram extruder, was also included in some of the comparisons. Evaluation of the extrusion behavior of the three extruders showed differences as well as similarities among them, depending on the composition of the formulation. Although the NICA and Alexanderwerk units extruded all formulations successfully, the Gabler extruder failed to do so at a content of > 60% of soluble ingredients, such as lactose or mannitol. The extrudate surface improved for all extruders with an increase in water content of formulations, but was generally smoother for the Gabler than for the NICA or the Alexanderwerk units. A formulation with colloidal Avicel as spheronization aid showed an identical extrusion behavior for all of the investigated extruders. Of the three extruders, the Gabler unit showed the highest heat generation during extrusion, especially when extruding formulations with a low water content or high contents of soluble excipients. However, when the loss of water during extrusion or spheronization for various formulations was compared, only a two-way ANOVA test on the differences between the water content after extrusion and after spheronization showed a statistically significant difference between the Alexanderwerk or NICA and the Gabler extruder. The two-way ANOVA also proved that this difference is significant only for some formulations, e.g., lactose + Avicel PH 101 formulations, but not for Avicel PH 101 formulations.
比较了三种不同的挤出机（亚历山大韦尔克重力进料辊式挤出机、加布勒轴向单螺杆挤出机和尼卡径向螺杆挤出机）对不同安慰剂制剂和非诺多泮微丸的适用性。在一些比较中还包括了第四种挤出机，即实验性柱塞挤出机。对这三种挤出机挤出行为的评估表明，根据制剂的组成，它们之间既有差异也有相似之处。尽管尼卡和亚历山大韦尔克的设备成功挤出了所有制剂，但加布勒挤出机在可溶性成分（如乳糖或甘露醇）含量超过60%时未能成功挤出。随着制剂含水量的增加，所有挤出机的挤出物表面都有所改善，但加布勒挤出机的挤出物表面通常比尼卡或亚历山大韦尔克的设备更光滑。一种以胶体微晶纤维素作为滚圆助剂的制剂，在所有研究的挤出机上表现出相同的挤出行为。在这三种挤出机中，加布勒设备在挤出过程中产生的热量最高，尤其是在挤出含水量低或可溶性辅料含量高的制剂时。然而，当比较各种制剂在挤出或滚圆过程中的水分损失时，只有对挤出后和滚圆后含水量差异进行的双向方差分析表明，亚历山大韦尔克或尼卡挤出机与加布勒挤出机之间存在统计学上的显著差异。双向方差分析还证明，这种差异仅对某些制剂（如乳糖+微晶纤维素PH 101制剂）显著，而对微晶纤维素PH 101制剂不显著。
