Pharmaceutical Technology Unit. Pharmacy and Pharmaceutical Technology Department, Pharmacy Faculty, Universitat de Barcelona, 08028 Barcelona, Spain.
Bioiberica S.A., Polígono Industrial Mas Puigvert, s/n. 08389 Palafolls, Barcelona, Spain.
Int J Pharm. 2014 Aug 15;470(1-2):15-27. doi: 10.1016/j.ijpharm.2014.04.068. Epub 2014 May 2.
As a methodology for characterizing substances with regard to its viability in direct compression, the SeDeM Diagram Expert System may be considered a new tool in terms of the number of parameters applied and its optimization. The paper is based on the experimental SeDeM characterization study of 51 directly compressible (DC) excipients. After selecting the parameters, and comparing the corresponding results, the choices available within the SeDeM Expert System could be expanded. Through applied variants, the maximum and optimal values of the DC diluent excipient were precisely defined and the mathematical limits of the parameters, functions and parametric indices that define the level of direct compressibility were established. These studies have allowed us to propose a new classification of excipients CD based on its rheological and compressibility capability, resulting in a periodic table of CD excipients. It has been determined that the best excipient for direct compression should have an index of good compression (IGC) of 8.832.
作为一种用于描述物质直接压缩可行性的方法,SeDeM 图谱专家系统在应用的参数数量及其优化方面可以被视为一种新工具。本文基于对 51 种可直接压缩(DC)辅料的 SeDeM 特性研究。在选择参数并比较相应结果后,可以扩展 SeDeM 专家系统中的可选方案。通过应用变体,可以精确地定义 DC 稀释剂辅料的最大值和最佳值,并确定定义直接可压缩性水平的参数、功能和参数指标的数学极限。这些研究使我们能够根据辅料的流变性和可压缩性能力提出一种新的分类法 CD,从而形成了 CD 辅料的元素周期表。研究结果表明,直接压缩的最佳辅料应具有 8.832 的良好压缩指数(IGC)。