Kelly Richard N, Kazanjian Jacqueline
Johnson & Johnson Pharmaceutical Research & Development, LLC, Room P-1029 McKean & Welsh Roads, Spring House, PA 19477-0776, USA.
AAPS PharmSciTech. 2006 May 26;7(2):E49. doi: 10.1208/pt070249.
The purpose of this paper is to describe the use of LGC Promochem AEA 1001 to AEA 1003 monosized fiber-analog shape standards in the study of the effect of particle shape on laser diffraction (LD) particle size analysis (psa). The psa of the AEA standards was conducted using LD psa systems from Beckman Coulter, Horiba, and Malvern Instruments. Flow speed settings, sample refractive index values, and sample cell types were varied to examine the extent to which the shape effect on LD psa results is modified by these variables. The volume and number probability plots resulting from these measurements were each characterized by a spread in the particle size distribution that roughly extended from the breadth to the longest dimension of the particles. For most of the selected sample refractive index values, the volume probability plots were characterized by apparent bimodal distributions. The results, therefore, provide experimental verification of the conclusions from theoretical studies of LD psa system response to monosized elliptical particles in which this apparent bimodality was the predicted result in the case of flow-oriented particles. The data support the findings from previous studies conducted over the past 10 years that have called into question the verity of the tenets of, and therefore the value of the application of, the equivalent spherical volume diameter theory and the random particle orientation model to the interpretation of LD psa results from measurements made on nonspherical particles.
本文旨在描述在研究颗粒形状对激光衍射(LD)粒度分析(PSA)的影响时,使用LGC普洛麦格公司的AEA 1001至AEA 1003单分散纤维状模拟形状标准物质的情况。使用贝克曼库尔特公司、堀场公司和马尔文仪器公司的LD PSA系统对AEA标准物质进行PSA分析。改变流速设置、样品折射率值和样品池类型,以研究这些变量对LD PSA结果形状效应的影响程度。这些测量得到的体积和数量概率图的特征均为粒度分布的展宽,大致从颗粒的宽度延伸至最长尺寸。对于大多数选定的样品折射率值,体积概率图呈现出明显的双峰分布特征。因此,这些结果为LD PSA系统对单分散椭圆形颗粒响应的理论研究结论提供了实验验证,在该理论研究中,对于取向流动的颗粒,这种明显的双峰性是预测结果。这些数据支持了过去10年中进行的先前研究结果,这些研究对等效球体积直径理论和随机颗粒取向模型在解释非球形颗粒LD PSA测量结果时的原理真实性以及应用价值提出了质疑。