Puckhaber Daniel, Voges Anna-Lena, Rane Supriya, David Sarah, Gururajan Bindhumadhavan, Finke Jan Henrik, Kwade Arno
Institute for Particle Technology, Technische Universität Braunschweig, Volkmaroder Straße 5, 38104 Braunschweig, Germany; Center of Pharmaceutical Engineering (PVZ), Technische Universität Braunschweig, Franz-Liszt-Straße 35A, 38106 Braunschweig, Germany.
Institute for Particle Technology, Technische Universität Braunschweig, Volkmaroder Straße 5, 38104 Braunschweig, Germany; Center of Pharmaceutical Engineering (PVZ), Technische Universität Braunschweig, Franz-Liszt-Straße 35A, 38106 Braunschweig, Germany.
Eur J Pharm Biopharm. 2023 Jun;187:24-33. doi: 10.1016/j.ejpb.2023.04.004. Epub 2023 Apr 8.
Modeling of structural and mechanical tablet properties consisting of multiple components, based on a minimum of experimental data is of high interest, in order to minimize time- and cost-intensive experimental trials in the development of new tablet formulations. The majority of commonly available models use the compressibility and compactibility of constituent components and establish mixing rules between those components, in order to predict the tablet properties of formulations containing multiple components. However, their applicability is limited to single materials, which form intact tablets (e.g. lactose, cellulose) and therefore, they cannot be applied for lubricants. Lubricants are required in the majority of industrial tablet formulations and usually influence the mechanical strength of tablets. This study combines the multi-component compaction model of Reynolds et al. (2017) with a recently published lubrication model (Puckhaber et al. 2020) to describe the impact of multiple components on a formulation consisting of two diluents and a lubricant. By that, this model combination displays a meaningful extension of existing compaction models and allows the systematic prediction of properties of lubricated multi-component tablets.
基于最少的实验数据对由多种成分组成的片剂的结构和机械性能进行建模备受关注，目的是在新片剂配方开发中尽量减少耗时且成本高昂的实验试验。大多数常用模型利用组成成分的可压缩性和可压实性，并在这些成分之间建立混合规则，以预测含有多种成分的配方的片剂性能。然而，它们的适用性仅限于能形成完整片剂的单一材料（如乳糖、纤维素），因此，它们不能用于润滑剂。大多数工业片剂配方都需要润滑剂，并且润滑剂通常会影响片剂的机械强度。本研究将雷诺兹等人（2017年）的多组分压实模型与最近发表的润滑模型（普克哈伯等人，2020年）相结合，以描述多种成分对由两种稀释剂和一种润滑剂组成的配方的影响。由此，这种模型组合展示了对现有压实模型的有意义扩展，并允许对润滑多组分片剂的性能进行系统预测。
