Mattsson S, Nyström C
Department of Pharmacy, Uppsala University, Box 580, SE-751 23 Uppsala, Sweden.
Drug Dev Ind Pharm. 2001;27(3):181-94. doi: 10.1081/ddc-100000236.
The aim of this study was to identify essential physical and mechanical properties of various binders and to investigate their influence on the tensile strength and porosity of tablets made from binary mixtures with sodium bicarbonate. The binders were characterized according to axial and radial tensile strength after compression into tablets, yield pressure and minimum porosity during compression, and elastic recovery after compression. The addition of a binder generally resulted in an increase in the tensile strength and a decrease in the porosity of the sodium bicarbonate tablets. The location of the binder in the voids between the sodium bicarbonate particles thus decreasing the porosity of the tablet seemed to be an important consideration. Consequently, the addition of binders with a low yield pressure value and a relatively small elastic recovery value (e.g., polyethylene glycol 3000 and polyvinylpyrrolidone) resulted in tablets of low porosity and high tensile strength, especially in the axial direction. The tensile strength of the pure binder also seemed to be important, especially for binders with a lower degree of deformability (e.g., microcrystalline cellulose and pregelatinised starch). The results also indicated the value of using both axial and radial tensile strength measurements in assessing the effect of a dry binder and showed that the importance of different binder properties varied according to the direction of the tablet strength measurements. The results demonstrated that the applied characteristics of the binders used in this study may serve as a useful tool in evaluating the effectiveness of binders.
本研究的目的是确定各种黏合剂的基本物理和机械性能,并研究它们对由碳酸氢钠二元混合物制成的片剂的抗张强度和孔隙率的影响。根据压制成片剂后的轴向和径向抗张强度、压制过程中的屈服压力和最小孔隙率以及压制后的弹性回复率对黏合剂进行表征。添加黏合剂通常会导致碳酸氢钠片剂的抗张强度增加,孔隙率降低。黏合剂在碳酸氢钠颗粒之间的空隙中的位置从而降低片剂的孔隙率似乎是一个重要的考虑因素。因此,添加具有低屈服压力值和相对较小弹性回复率的黏合剂(例如聚乙二醇3000和聚乙烯吡咯烷酮)会得到低孔隙率和高抗张强度的片剂,尤其是在轴向方向上。纯黏合剂的抗张强度似乎也很重要,特别是对于可变形性较低的黏合剂(例如微晶纤维素和预胶化淀粉)。结果还表明,在评估干黏合剂的效果时使用轴向和径向抗张强度测量值的价值,并表明不同黏合剂性能的重要性根据片剂强度测量的方向而有所不同。结果表明,本研究中使用的黏合剂的应用特性可作为评估黏合剂有效性的有用工具。