Mechanics of Pharmaceutical Pellets-Constitutive Properties, Deformation, and Breakage Behavior.
Mechanics of Pharmaceutical Pellets-Constitutive Properties, Deformation, and Breakage Behavior.
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DOI：
10.1016/j.xphs.2017.08.022
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发表时间：
2018-02
影响因子：
3.8
通讯作者：
Alexander Russell;R. Šibanc;R. Dreu;P. Müller
中科院分区：
文献类型：
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作者：
Alexander Russell;R. Šibanc;R. Dreu;P. Müller
为了确保基于单元的口服固体剂型的稳健制造，在随后的处理单元操作（例如，在包衣、任选的轴向压缩、处理、包装、储存和运输条件期间承受机械应力），工艺设计应包括考虑组成颗粒的精确微观、宏观和整体性质的精确极限。该通信提供了一个全面复杂的微机械性能数据库和颗粒的破损概率分布函数，说明了涂层的硬化和强化效果以及结构水分的软化和弱化效果。进一步的见解，如（接触）历史依赖的软化减压过程中，应变硬化反复强调，强度恢复干燥，和破碎模式开裂。本文的内容是基于方便执行的实验室规模的直径压缩模型微晶纤维素颗粒的测量证明的方法的可行性和有效性的贡献。
To ensure robust manufacturing of unit-based oral solid dosage forms with minimal structural imperfections and high mechanical reliability across subsequent processing unit operations (e.g., withstanding mechanical stresses during coating, optional axial compression, handling, packaging, storage, and transport conditions), process design should include consideration of precise limits of accurate micro, macro, and bulk properties of the constituent pellets. This communication presents a comprehensive intricate database of micromechanical properties' and breakage probability distribution functions of pellets, illustrating the stiffening and strengthening effects of coatings and the softening and weakening effects of structural moisture. Further insights such as the (contact) history-dependent softening during decompression, strain hardening on repeated stressing, strength recovery by drying, and the fragmentation pattern by cracking are also presented. The contents herein are based on conveniently performable lab-scale diametrical compression measurements on model microcrystalline cellulose pellets—demonstrating feasibility of the approach and validity of the contribution.