MacRitchie K A, Newton J M, Rowe R C
The School of Pharmacy, University of London, 29/39 Brunswick Square, London WC1N 1AX, UK.
Eur J Pharm Sci. 2002 Oct;17(1-2):43-50. doi: 10.1016/s0928-0987(02)00130-6.
The consistency of wet powder masses produced from two ratios (7:3 and 8:2) of alpha-lactose monohydrate (L) and microcrystalline cellulose (MCC) mixed with a range of water contents has been assessed with a parallel plate controlled stress rheometer. The range of water contents, which could be studied, was restricted to those, which could be extruded uniformly by a ram extruder. In the creep mode, the instantaneous compliance increased as the water content increased for both L:MCC ratios illustrating the increasing deformability of the mixtures with increasing water content. The derived apparent viscosity of the mixtures as a function of shear rate, increased as the water content decreased and the values for all the systems fell on a common line. This indicates that the measurements are providing a reliable assessment of the mixtures and that the change in water content and L:MCC ratio provides systems, whose change of viscosity with rate of shear is consistent at low rates of shear. The values of the storage and loss moduli obtained from oscillatory measurements, increased with a decrease in water content but this time the two ratios of L:MCC were not on a common line when related to the water content of the mixtures. There was a range of water levels over which both the values of the storage and loss moduli were approximately constant. This corresponded to the level of water, which produced the pellets of the smallest diameter and range of diameters and were of the most spherical shape when produced by a ram extruder and spheronization. For 8:2 L:MCC ratio, there appeared to be a value for both the storage and the loss moduli above which the wet mass could not produce good pellets. For the 7:3 L:MCC these limiting levels were not achieved before extrusion with steady state conditions could be maintained without the mass being too wet or too dry. Instead, there appeared to be minimum levels of the moduli required to ensure that the mixtures were able to produce good pellets.
使用平行板控制应力流变仪评估了由两种比例(7:3和8:2)的一水合α-乳糖(L)和微晶纤维素(MCC)混合而成的湿粉末物料在一系列含水量下的一致性。能够研究的含水量范围限于那些可以通过柱塞式挤出机均匀挤出的含水量。在蠕变模式下,对于两种L:MCC比例,随着含水量增加,瞬时柔量增加,这说明混合物的可变形性随着含水量增加而增大。混合物的表观粘度随剪切速率的变化关系表明,随着含水量降低,表观粘度增加,并且所有体系的值都落在同一条直线上。这表明这些测量为混合物提供了可靠的评估,并且含水量和L:MCC比例的变化提供了这样的体系,即在低剪切速率下,其粘度随剪切速率的变化是一致的。通过振荡测量获得的储能模量和损耗模量的值随着含水量降低而增加,但这一次当与混合物的含水量相关时,两种L:MCC比例并不在同一条直线上。在一定的含水量范围内,储能模量和损耗模量的值大致保持恒定。这对应于通过柱塞式挤出机和滚圆法生产时产生最小直径和直径范围且最接近球形颗粒的含水量水平。对于8:2的L:MCC比例,储能模量和损耗模量似乎都存在一个值,高于该值时湿物料无法制成良好的颗粒。对于7:3的L:MCC比例,在能够维持稳态条件而物料不过湿或过干的情况下进行挤出之前,并未达到这些极限水平。相反,似乎存在确保混合物能够制成良好颗粒所需的模量的最低水平。