Department of Chemical Engineering, University of Birmingham, Birmingham, UK.
Drug Dev Ind Pharm. 2012 Jan;38(1):111-22. doi: 10.3109/03639045.2011.594802. Epub 2011 Aug 3.
A systematic evaluation on the effect of magnesium stearate on the transmission of a placebo formulation from the hopper to the rolls during screw fed roller compaction has been carried out. It is demonstrated that, for a system with two 'knurled' rollers, addition of 0.5% w/w magnesium stearate can lead to a significant increase in ribbon mass throughput, with a consequential increase in roll gap, compared to an unlubricated formulation (manufactured at equivalent process conditions). However, this effect is reduced if one of the rollers is smooth. Roller compaction of a lubricated formulation using two smooth rollers was found to be ineffective due to a reduction in friction at the powder/roll interface, i.e. powder was not drawn through the rollers leading to a blockage in the feeding system. An increase in ribbon mass throughput could also be achieved if the equipment surfaces were pre-lubricated. However this increase was found to be temporary suggesting that the residual magnesium stearate layer was removed from the equipment surfaces. Powder sticking to the equipment surfaces, which is common during pharmaceutical manufacturing, was prevented if magnesium stearate was present either in the blend, or at the roll surface. It is further demonstrated that the influence of the hopper stirrer, which is primarily used to prevent bridge formation in the hopper and help draw powder more evenly into the auger chamber, can lead to further mixing of the formulation, and could therefore affect a change in the lubricity of the carefully blended input material.
已经对硬脂酸镁在螺旋给料辊压过程中从料斗向轧辊输送安慰剂制剂的传递效果进行了系统评价。结果表明，对于具有两个“滚花”轧辊的系统，与未润滑制剂（在等效工艺条件下制造）相比，添加 0.5%w/w 的硬脂酸镁可以显著增加带状物料的吞吐量，并相应增加轧辊间隙。然而，如果其中一个轧辊是光滑的，则这种效果会降低。使用两个光滑轧辊对润滑制剂进行辊压发现是无效的，因为在粉末/轧辊界面处的摩擦力降低，即粉末未被拉过轧辊，导致进料系统堵塞。如果预先润滑设备表面，也可以提高带状物料的吞吐量。然而，发现这种增加是暂时的，表明残留的硬脂酸镁层从设备表面被去除。如果在混合物中或在轧辊表面存在硬脂酸镁，则可以防止粉末粘在设备表面上，这在制药生产中很常见。进一步表明，主要用于防止料斗中搭桥并帮助更均匀地将粉末吸入螺旋室的料斗搅拌器的影响可能导致制剂进一步混合，从而可能影响精心混合的输入材料的润滑性变化。
