Roller compaction of moist pharmaceutical powders.

The compression behaviour of powders during roller compaction is dominated by a number of factors, such as process conditions (roll speed, roll gap, feeding mechanisms and feeding speed) and powder properties (particle size, shape, moisture content). The moisture content affects the powder properties, such as the flowability and cohesion, but it is not clear how the moisture content will influence the powder compression behaviour during roller compaction. In this study, the effect of moisture contents on roller compaction behaviour of microcrystalline cellulose (MCC, Avicel PH102) was investigated experimentally. MCC samples of different moisture contents were prepared by mixing as-received MCC powder with different amount of water that was sprayed onto the powder bed being agitated in a rotary mixer. The flowability of these samples were evaluated in terms of the poured angle of repose and flow functions. The moist powders were then compacted using the instrumented roller compactor developed at the University of Birmingham. The flow and compression behaviour during roller compaction and the properties of produced ribbons were examined. It has been found that, as the moisture content increases, the flowability of moist MCC powders decreases and the powder becomes more cohesive. As a consequence of non-uniform flow of powder into the compaction zone induced by the friction between powder and side cheek plates, all produced ribbons have a higher density in the middle and lower densities at the edges. For the ribbons made of powders with high moisture contents, different hydration states across the ribbon width were also identified from SEM images. Moreover, it was interesting to find that these ribbons were split into two halves. This is attributed to the reduction in the mechanical strength of moist powder compacts with high moisture contents produced at high compression pressures.

The effect of lubrication on density distributions of roller compacted ribbons.

Roller compaction is a continuous dry granulation process for producing free flowing granules in order to increase the bulk density and uniformity of pharmaceutical formulations. It is a complicated process due to the diversity of powder blends and processing parameters involved. The properties of the produced ribbon are dominated by a number of factors, such as the powder properties, friction, roll speed, roll gap, feeding mechanisms and feeding speed, which consequently determine the properties of the granules (size distribution, density and flow behaviour). It is hence important to understand the influence of these factors on the ribbon properties. In this study, an instrumented roller press developed at the University of Birmingham is used to investigate the effect of lubrication on the density distribution of the ribbons. Three different cases are considered: (1) no lubrication, (2) lubricated press, in which the side cheek plates of the roller press are lubricated, and (3) lubricated powder, for which a lubricant is mixed into the powder. In addition, how the powders are fed into the entry region of the roller press and its influence on ribbon properties are also investigated. It is found that the method of feeding the powder into the roller press plays a crucial role in determining the homogeneity of the ribbon density. For the roller press used in this study, a drag angle (i.e., the angle formed when the powder is dragged into the roller press) is introduced to characterise the powder flow pattern in the feeding hopper. It is shown that a sharper drag angle results in a more heterogeneous ribbon. In addition, the average ribbon density depends upon the peak pressure and nip angle. The higher the peak pressure and nip angle are, the higher the average ribbon density is. Furthermore, the densification behaviour of the powder during roller compaction is compared to that during die compaction. It has been shown that the densification behaviour during these two processes is similar if the ribbons and the tablets have the same thickness.