Department of Pharmacy, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen Ø, Denmark.
J Pharm Sci. 2013 Dec;102(12):4347-52. doi: 10.1002/jps.23741. Epub 2013 Oct 8.
A dimensionless index that quantifies the brittle or ductile character of tablets is presented. The work of failure (WOF) of crushed or broken flat tablets is calculated by numerical integration of the force-displacement measurement in a flexure tester. The ratio between WOF and the crushing force (F) corrected for the diameter of the tablet (D) is proposed to express the brittle/ductile index (BDI). [Formula: see text] This dimensionless index quantitatively denotes the brittle/ductile character of the compacted material as the normalized deformation in percentage of a cylindrical tablet at the breaking point. For ideal brittle materials, the BDI value will be 0 and for complete plastic deformation, that is, a total compression of the tablet without fracture, BDI will be 100. The validity and discriminative power is demonstrated on mixtures of microcrystalline cellulose and lactose. The robust measure of brittleness with an acceptable accuracy is obtained with only a minor influence of the tablet diameter and the speed of platen.
提出了一个无量纲指数，用于量化片剂的脆性或延性特征。通过数值积分弯曲测试仪中的力-位移测量来计算粉碎或破碎平板的失效功 (WOF)。提出了将 WOF 与平板直径 (D) 校正后的破碎力 (F) 之比表示为脆性/延性指数 (BDI)。[公式：见正文] 该无量纲指数定量表示了压实材料的脆性/延性特征，即圆柱形片剂在断裂点的归一化变形百分比。对于理想的脆性材料，BDI 值为 0，而对于完全塑性变形，即片剂无断裂的完全压缩，BDI 值为 100。通过微晶纤维素和乳糖的混合物验证了其有效性和区分能力。该脆性测量方法具有稳健性，并且准确性可以接受，仅受平板直径和压盘速度的轻微影响。
