Department of Pharmaceutical Technology, Faculty of Pharmacy, University of Ljubljana, Aškerčeva cesta 7, 1000 Ljubljana, Slovenia.
Department of Pharmaceutical Technology, Faculty of Pharmacy, University of Ljubljana, Aškerčeva cesta 7, 1000 Ljubljana, Slovenia.
Eur J Pharm Sci. 2018 Aug 30;121:218-227. doi: 10.1016/j.ejps.2018.05.028. Epub 2018 May 29.
The paper considers a novel, modified equation for evaluation of relationship between tablet tensile strength, bonding area and bonding strength with inclusion of fragmentation as particle deformation mechanism. Four types of lactose particles for direct compression were assessed for their micromeritic and mechanical properties (compressibility and compactibility), with particular focus on fragmentation behaviour, bonding area and bonding strength. Compressibility properties were assessed using three established models. Walker and Kuentz-Leuenberger models distinguished lactose plastic properties more effectively in contrast to the Heckel model. Spherical agglomerates of lactose were most prone to fragmentation as determined with the fragmentation propensity coefficient and the number of interparticulate bonds. Fragmentation, together with plastic deformation were found to be the governing factors for tablet tensile strength in α-lactose samples, while high bonding force primarily controlled the tablet tensile strength of anhydrous lactose. Tensile strength of all lactose tablets showed best correlation to the ratio of fragmentation propensity and Walker compressibility coefficient, which is proposed as better deformation index, intended to describe the overall deformation properties of lactose more precisely. A novel expression for determining bonding area is proposed, established on the enhanced deformation index, which includes both plastic deformation and fragmentation as bond formation mechanisms.
本文提出了一种新的、改进的方程，用于评估片剂拉伸强度、结合面积和结合强度之间的关系，其中包括颗粒变形机制中的碎裂。评估了四种用于直接压缩的乳糖颗粒的微粉学和机械性能（可压缩性和可压缩性），特别关注碎裂行为、结合面积和结合强度。使用三种已建立的模型评估可压缩性。与 Heckel 模型相比，Walker 和 Kuentz-Leuenberger 模型更有效地区分了乳糖的塑性特性。乳糖的球形团聚体最容易发生碎裂，这可以用碎裂倾向系数和颗粒间结合数来确定。在 α-乳糖样品中，发现碎裂和塑性变形是片剂拉伸强度的主要控制因素，而高结合力主要控制无水乳糖片剂的拉伸强度。所有乳糖片剂的拉伸强度与碎裂倾向系数和 Walker 可压缩性系数的比值相关性最好，提出该比值作为更好的变形指数，旨在更精确地描述乳糖的整体变形特性。提出了一种新的确定结合面积的表达式，该表达式基于增强的变形指数，其中包括塑性变形和碎裂作为结合形成机制。
