The impact of solid-state form, water content and surface area of magnesium stearate on lubrication efficiency, tabletability, and dissolution
The impact of solid-state form, water content and surface area of magnesium stearate on lubrication efficiency, tabletability, and dissolution
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硬脂酸镁的固态形态、含水量和表面积对润滑效率、压片性和溶出度的影响
DOI：
10.1080/10837450.2020.1839763
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发表时间：
2021
影响因子：
3.4
通讯作者：
Munson, Eric J.
中科院分区：
文献类型：
--
作者：
Calahan, Julie L.;Paul, Shubhajit;Yanez, Evelyn G.;DeNeve, Daniel;Sun, Changquan C.;Munson, Eric J.
硬脂酸镁（MgSt）是片剂生产中广泛使用的药用润滑剂。然而，水合物形式和表面积的批次间变异性可导致片剂性能不一致。在这项工作中，几个独特的MgSt样品进行了研究：传统的一水合物样品与高表面积，二水合物形式与高和低表面积，和无序的形式与低和中等的水含量。研究了固体形式和颗粒性质对模型直接压片处方中片剂润滑效率、可压片性和溶出度的影响。研究发现，与无序形式相比，一水合物和二水合物形式具有良好的润滑效率，而无序形式具有最好的压片性。溶解速率与表面积相关，其中较慢的溶解速率对应于较高的MgSt表面积。具有较低表面积的二水合物样品在润滑效率、可压片性和溶出度方面对于该模型制剂具有最佳性能。总体而言，可以得出结论，对于特定配方，选择最合适的MgSt等级取决于MgSt特性对润滑效率、可压片性和溶出度的影响的综合评价。
Magnesium stearate (MgSt) is a widely used pharmaceutical lubricant in tablet manufacturing. However, batch-to-batch variability in hydrate form and surface area can lead to inconsistency in tablet performance. In this work, several unique MgSt samples were studied: traditional monohydrate samples with high surface area, dihydrate forms with high and low surface area, and disordered forms with low and medium water content. The effects of solid-state form and particle properties on lubrication efficiency, tabletability and dissolution were studied for tablets in a model direct compression formulation. It was found that the monohydrate and dihydrate forms had good lubrication efficiency compared to the disordered form, while the disordered form had the best tabletability. The dissolution rate correlated with surface area, where slower dissolution rates corresponded with higher MgSt surface areas. The dihydrate sample with lower surface area had the best performance for this model formulation, in terms of lubrication efficiency, tabletability and dissolution. Overall, it is concluded that the choice of the most appropriate grade of MgSt for a particular formulation depends on a comprehensive evaluation of the impact of MgSt properties on lubrication efficiency, tabletability and dissolution.
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