Technische Universität Braunschweig, Institute for Particle Technology, Volkmaroder Straße 5, 38104 Braunschweig, Germany; Technische Universität Braunschweig, Center of Pharmaceutical Engineering (PVZ), Franz-Liszt-Straße 35A, 38106 Braunschweig, Germany.
Technische Universität Braunschweig, Institute for Particle Technology, Volkmaroder Straße 5, 38104 Braunschweig, Germany; Technische Universität Braunschweig, Center of Pharmaceutical Engineering (PVZ), Franz-Liszt-Straße 35A, 38106 Braunschweig, Germany.
Eur J Pharm Biopharm. 2021 Aug;165:203-218. doi: 10.1016/j.ejpb.2021.05.009. Epub 2021 May 16.
The deformation behaviour of a powder and, thus, of the individual particles is a crucial parameter in powder compaction and affects powder compressibility and compactibility. The classical approach for the characterization of the deformation behaviour is the performance of powder compression experiments combined with the application of mathematical models, such as the Heckel-Model, for the derivation of characteristic compression parameters. However, the correlation of these parameters with the deformation behaviour is physically often not well understood. Single particle compression and nanoindentation enables the in-depth investigation of the deformation behaviour of particulate materials. In this study, single particle compression experiments were performed for the characterization of the deformation behaviour of common pharmaceutical excipients and active pharmaceutical ingredients (APIs) with various, irregular particle morphologies of industrial relevance and the findings are compared with the results from powder compression. The technique was found useful for the characterization and clarification of the qualitative deformation behaviour. However, the derivation of a quantitative functional relationship between single particle deformation behavior and powder compression is limited. Nanoindentation was performed as complementary technique for the characterization of the micromechanical behavior of the APIs. A linear relationship between median indentation hardness and material densification strength as characteristic parameter derived by in-die powder compression analysis is found.
粉末的变形行为，以及由此产生的单个颗粒的变形行为，是粉末压实过程中的一个关键参数，它影响着粉末的可压缩性和压实性。表征变形行为的经典方法是进行粉末压缩实验，并结合使用数学模型，如 Heckel 模型，以得出特征压缩参数。然而，这些参数与变形行为之间的相关性在物理上往往理解得不够透彻。单颗粒压缩和纳米压痕技术可以深入研究颗粒材料的变形行为。在这项研究中，进行了单颗粒压缩实验，以表征具有各种不规则颗粒形态的常见药物赋形剂和活性药物成分 (API) 的变形行为，实验结果与粉末压缩实验的结果进行了比较。该技术对于定性变形行为的表征和澄清是有用的。然而，将单颗粒变形行为与粉末压缩之间的定量函数关系推导出来是有限的。纳米压痕技术作为一种补充技术，用于表征 API 的微力学行为。发现中径压痕硬度与通过模内粉末压缩分析得出的材料致密化强度这一特征参数之间存在线性关系。
