Michrafy A, Michrafy M, Kadiri M S, Dodds J A
Chemical Engineering Laboratory for Particulate Solids, UMR CNRS 2392, Ecole des Mines d'Albi-Carmaux, Campus Jarlard, Albi, France.
Int J Pharm. 2007 Mar 21;333(1-2):118-26. doi: 10.1016/j.ijpharm.2006.10.008. Epub 2006 Oct 10.
There has recently been an increased interest in predicting the tensile strength of binary tablets from the properties of the individual components. In this paper, measurements are reported for tensile strength of tablets compressed from single-component and binary powder mixtures of lactose with microcrystalline cellulose (MCC), and lactose with two types of silicified microcrystalline cellulose (SMCC and SMCC-HD), which are different in compressibility. Measurements show the tensile strength increases with the relative density for single powders, and both with the relative density and the mass fraction of cellulose in the mixtures. It was also observed, for binary mixtures compacted at 50 and 150 MPa, that there was a slight variation in porosity with the mass fraction of celluloses. The predictions of the tensile strength of binary tablets from the characteristics of the single-components was analysed with the extended Ryshkewitch-Duckworth model by assuming both linear and power law mixing rules for the determination of the parameters "tensile strength at zero porosity and bonding capacity constant". As consequence, four models were analysed and compared with measurements using criteria based on the standard deviation from the mean values. Results showed a good prediction using a linear mixing rule combined with the power law. However, as the predictions of these models depend on the powders and the porosity range for the characterization of single-components, none of them can be systematically considered as being the best to predict binary behaviour from data for individual powders.
最近，人们对根据各组分的性质预测二元片剂的抗张强度越来越感兴趣。本文报道了由乳糖与微晶纤维素（MCC）以及乳糖与两种可压性不同的硅化微晶纤维素（SMCC和SMCC-HD）的单组分和二元粉末混合物压制而成的片剂的抗张强度测量结果。测量结果表明，单一组分粉末的抗张强度随相对密度增加，而混合物的抗张强度则随相对密度以及纤维素的质量分数增加。对于在50和150MPa下压制成型的二元混合物，还观察到孔隙率随纤维素质量分数略有变化。通过假设线性和幂律混合规则来确定“零孔隙率下的抗张强度和结合能力常数”参数，利用扩展的Ryshkewitch-Duckworth模型分析了根据单一组分特性预测二元片剂抗张强度的情况。结果，分析了四个模型，并使用基于与平均值的标准偏差的标准与测量值进行比较。结果表明，使用线性混合规则结合幂律能得到较好的预测结果。然而，由于这些模型的预测取决于用于表征单一组分的粉末和孔隙率范围，因此没有一个模型可以被系统地认为是根据单一组分数据预测二元行为的最佳模型。
