Systematic evaluation of common lubricants for optimal use in tablet formulation
Systematic evaluation of common lubricants for optimal use in tablet formulation
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DOI：
10.1016/j.ejps.2018.02.013
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发表时间：
2018-05-30
影响因子：
4.6
通讯作者：
Sun, Changquan Calvin
中科院分区：
文献类型：
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作者：
Paul, Shubhajit;Sun, Changquan Calvin
作为大规模片剂生产的基本配方成分，该润滑剂通过减少模壁摩擦来保护模具。不幸的是，润滑也经常导致片剂特性的不利影响，如长时间崩解、缓慢溶解和降低机械强度。因此，片剂配方中润滑剂的选择及其最佳浓度是片剂配方开发中的一个关键决策，以获得低模壁摩擦，同时将对其他片剂性能的负面影响降至最低。系统研究了硬脂酸镁、硬脂酰富马酸钠和硬脂酸三种商用片剂润滑剂在塑料和脆性基质中的作用，以阐明它们在降低模壁摩擦、片剂强度、片剂硬度、片剂脆碎度和片剂崩解动力学方面的作用。清楚地了解常用润滑剂的润滑效率以及它们对片剂特性的影响将有助于未来的片剂配方工作。
As an essential formulation component for large-scale tablet manufacturing, the lubricant preserves tooling by reducing die-wall friction. Unfortunately, lubrication also often results in adverse effects on tablet characteristics, such as prolonged disintegration, slowed dissolution, and reduced mechanical strength. Therefore, the choice of lubricant and its optimal concentration in a tablet formulation is a critical decision in tablet formulation development to attain low die-wall friction while minimizing negative impact on other tablet properties. Three commercially available tablet lubricants, i.e., magnesium stearate, sodium stearyl fumerate, and stearic acid, were systematically investigated in both plastic and brittle matrices to elucidate their effects on reducing die-wall friction, tablet strength, tablet hardness, tablet friability, and tablet disintegration kinetics. Clear understanding of the lubrication efficiency of commonly used lubricants as well as their impact on tablet characteristics would help future tablet formulation efforts.