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首页> 外文期刊>Powder Technology: An International Journal on the Science and Technology of Wet and Dry Particulate Systems >Comparison of granule properties produced using Twin Screw Extruder and High Shear Mixer: A step towards understanding the mechanism of twin screw wet granulation
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Comparison of granule properties produced using Twin Screw Extruder and High Shear Mixer: A step towards understanding the mechanism of twin screw wet granulation

机译：使用双螺杆挤出机和高剪切混合机生产的颗粒特性的比较：迈向理解双螺杆湿法制粒机理的一步

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摘要

The wet granulation process plays an important role in the pharmaceutical industry. With the introduction of a Twin Screw Extruder (TSE), it allows the possibility of wet granulation to be run continuously in contrast to a conventional batch process using a High Shear Mixer (HSM). However, the mechanism of Twin Screw Extruder wet granulation is not well understood and the aim of this study is to investigate this process and compare it with the High Shear Mixer granulation process with regard to the granule properties. Granules of pure microcrystalline cellulose (MCC) were produced using a Twin Screw Extruder and a High Shear Mixer with water as liquid binder under different process conditions and formulations. The properties (particle size distribution, shape, surface morphology, internal structure, internal porosity and strength) of the granules were then compared. It was found that the granules produced by the two methods have different physical properties. Granules produced by the HSM are spherical in shape and are made up of smaller granules through coalescence process. It is believed that the granules produced by HSM in the present study are over-granulated which leads to the production of strong dense granules. On the other hand, granules produced by TSE have irregular shapes with tiny pores spread uniformly throughout the granules. The granules produced by HSM are affected by process conditions and are stronger at higher impeller speed. However, granules made by TSE are consistent in strength and relatively independent of process conditions. Due to over-granulation in HSM process, the granules produced result in the production of weak tablets whilst granules made by TSE manage to produce stronger tablets. Finally, by observing the structure of the granules, it is believed that the mechanism of HSM and TSE granulation is different. Although the granules made by HSM were over-granulated, it shows the existence of consolidation process that is apparently absent in TSE granulation. Nevertheless, more work will be needed to further understand the mechanism in continuous TSE wet granulation process.
机译：湿法制粒过程在制药行业中起着重要作用。与双螺杆挤出机（TSE）的引入相比，与使用高剪切混合机（HSM）的常规分批工艺相比，它可以连续进行湿法制粒。但是，对双螺杆挤出机湿法制粒的机理尚不十分了解，本研究的目的是研究该工艺并将其与高剪切混合机制粒工艺的颗粒性质进行比较。使用双螺杆挤出机和高剪切混合机，以水为液体粘合剂，在不同的工艺条件和配方下生产纯微晶纤维素（MCC）颗粒。然后比较颗粒的性质（粒度分布，形状，表面形态，内部结构，内部孔隙率和强度）。发现通过两种方法生产的颗粒具有不同的物理性质。由HSM生产的颗粒是球形的，并且通过聚结过程由较小的颗粒组成。据信，由HSM在本研究中生产的颗粒是过度颗粒化的，这导致产生强致密颗粒。另一方面，TSE生产的颗粒具有不规则形状，细孔均匀分布在整个颗粒中。 HSM生产的颗粒受工艺条件的影响，并且在较高的叶轮速度下会更坚固。但是，TSE制成的颗粒强度一致，并且相对不受工艺条件的影响。由于HSM过程中的过度制粒，产生的颗粒导致产生的片剂较弱，而TSE制得的颗粒设法产生的颗粒更牢固。最后，通过观察颗粒的结构，可以认为HSM和TSE制粒的机理是不同的。尽管由HSM制得的颗粒被过度制粒，但它表明存在固结过程，而固结过程在TSE制粒中显然不存在。然而，将需要更多的工作来进一步了解连续TSE湿法制粒过程中的机理。

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