Doelker Eric, Massuelle Danielle
School of Pharmacy, University of Geneva, Geneva, Switzerland.
Eur J Pharm Biopharm. 2004 Sep;58(2):427-44. doi: 10.1016/j.ejpb.2004.03.011.
Instrumented presses used in tabletting research and development are normally equipped to measure punch force and displacement. Die-wall monitoring is rare, probably because instrumentation and calibration are quite difficult. The authors critically examine the tenets of radial pressure measurement in compression physics. The theoretical background concerning axial to radial stress transmission during the different phases of the compression cycle is presented. The literature reporting on the use of radial stress measurement to assess the self-lubricating properties of materials or the effect of lubricants is reviewed. Examples of interpretation of radial pressure cycles to define the basic material behaviour are given. The influence of particle size and shape as well as that of process and formulation variables on die-wall response are also discussed. Substantial inconsistencies can be seen in the literature with respect to the interpretation of experimental data, often because of the poor reliability of results and mostly because powders are essentially not solid, isotropic bodies. There is also a distinct lack of complementary tabletting parameters that would help understanding their comparative benefits. For this reason, original data on 13 model compounds are presented together with a classification of the materials encountered in pharmaceutical tabletting, based on selected parameters. In conclusion, none of the determined parameters, including those derived from radial pressure measurement, is able, alone, to predict the material behaviour under compression. Although die-wall instrumentation contributes little to the development of improved tablet formulations, it is valuable for characterising the mechanical properties of the materials. This is particularly advantageous given that the mechanical properties account for variations in tabletting performance to a much greater extent than the magnitude of the interparticulate attractions. Nevertheless, because of the peculiar nature of powders compared to solid, isotropic bodies, there is a need to develop new models for analysing their behaviour and to put more emphasis on examination of time-dependent deformation in the later stage of the compression cycle.
用于压片研发的仪器化压力机通常配备有测量冲压力和位移的装置。模壁监测很少见,可能是因为仪器安装和校准相当困难。作者批判性地审视了压缩物理学中径向压力测量的原理。介绍了压缩循环不同阶段轴向应力向径向应力传递的理论背景。回顾了关于使用径向应力测量来评估材料的自润滑性能或润滑剂效果的文献。给出了通过解释径向压力循环来定义基本材料行为的示例。还讨论了粒径和形状以及工艺和配方变量对模壁响应的影响。在文献中,对于实验数据的解释存在大量不一致之处,这通常是由于结果的可靠性较差,而且主要是因为粉末本质上不是固体、各向同性物体。此外,明显缺乏有助于理解其相对优势的互补压片参数。因此,本文给出了13种模型化合物的原始数据,并基于选定参数对药物压片过程中遇到的材料进行了分类。总之,所确定的参数,包括那些从径向压力测量中得出的参数,没有一个能够单独预测材料在压缩下的行为。尽管模壁仪器对改进片剂配方的开发贡献不大,但它对于表征材料的机械性能很有价值。考虑到机械性能在压片性能变化中所占的比例比颗粒间吸引力的大小大得多,这一点尤其有利。然而,由于与固体各向同性物体相比,粉末具有特殊性质,因此需要开发新的模型来分析其行为,并更加重视压缩循环后期随时间变化的变形研究。