Functionality of magnesium stearate derived from bovine and vegetable sources: dry granulated tablets.
Functionality of magnesium stearate derived from bovine and vegetable sources: dry granulated tablets.
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源自牛和植物的硬脂酸镁的功能：干颗粒片。
DOI：
10.1002/jps.21381
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发表时间：
2008
影响因子：
3.8
通讯作者：
M. Khan
中科院分区：
文献类型：
--
作者：
Mazen L. Hamad;Abhay Gupta;R. Shah;Robbe C. Lyon;V. Sayeed;M. Khan
硬脂酸镁是一种功能性赋形剂，用于保证片剂的有效排出。本研究比较了植物级和牛级硬脂酸镁的功能。采用模型配方直接压缩和干燥造粒制备片剂。对散装粉末、颗粒中间体和成品片剂进行了物理和化学测试，以提供两种等级硬脂酸镁的全面比较。两个等级的原料表征在粒度、表面积、真密度和总含水量方面没有差异。然而，在脂肪酸组成、表面张力和zeta电位上发现了显著的差异。物理混合制剂的排片力是可变的，在某些浓度下，两个等级的硬脂酸镁的排片力相似，而在其他浓度下，排片力不同。含有植物基硬脂酸镁的干粒状配方比含有牛基硬脂酸镁的配方具有更低的弹射力。两种方法制备的两级硬脂酸镁片的溶出度无差异。结果表明，硬脂酸镁在润滑油效率方面的互换性取决于其使用水平和制造方法。
Magnesium stearate is a functional excipient used to ensure efficient ejection of tablets. This study compares the functionality of a vegetable and bovine grade of magnesium stearate. Tablets were prepared by direct compression and dry granulation of a model formulation. Physical and chemical tests were performed on bulk powders, granule intermediates, and finished tablets to provide a comprehensive comparison of the two grades of magnesium stearates. Raw material characterization of the two grades showed no difference in particle size, surface area, true density, and total moisture content. However, significant differences in fatty acid composition, surface tension, and zeta potential were detected. Tablet ejection force for the physical mixture formulations was variable, showing similar ejection force for the two grades of magnesium stearate at some concentrations and different ejection forces at other concentrations. The dry granulated formulation containing vegetable-based magnesium stearate showed a lower ejection force than the formulation containing bovine-based magnesium stearate. There was no difference between the dissolution profiles of the tablets containing the two grades of magnesium stearate prepared by both methods. The results indicated that magnesium stearate interchangeability with respect to lubricant efficiency depends upon the level in which it is used and the manufacturing method.