Gupta Abhay, Hamad Mazen L, Tawakkul Mobin, Sayeed Vilayat A, Khan Mansoor A
Division of Product Quality Research, Office of Testing and Research, Office of Pharmaceutical Science, Food and Drug Administration, 10903 New Hampshire Avenue, LS building 64, Silver Spring, Maryland 20993-002, USA.
AAPS PharmSciTech. 2009;10(2):500-4. doi: 10.1208/s12249-009-9229-y. Epub 2009 Apr 24.
The purpose of this work was to evaluate and compare the functionality of bovine fatty acids-derived (MgSt-B) and vegetable fatty acids-derived (MgSt-V) magnesium stearate powders when used for the lubrication of granules prepared by high-shear (HSG) and fluid bed (FBG) wet granulation methods. The work included evaluation of tablet compression and ejection forces during tabletting and dissolution testing of the compressed tablets. Granules prepared by both granulation methods required significantly lower ejection force (p < 0.01) when lubricated with the MgSt-V powder as compared to those lubricated with the MgSt-B powder. Granules prepared by the HSG method and lubricated with the MgSt-V powder also required significantly lower compression force (p < 0.01) to produce tablets of similar weight and hardness as compared to those lubricated with the MgSt-B powder. The dissolution profiles were not affected by these differences and were the same for tablets prepared by same granulation method and lubricated with either magnesium stearate powder. The results indicate significant differences (p < 0.01) between lubrication efficiency of the MgSt-B and the MgSt-V powders and emphasize the importance of functionality testing of the MgSt powders to understand the impact of these differences.
本研究旨在评估和比较牛脂肪酸衍生的（MgSt-B）和植物脂肪酸衍生的（MgSt-V）硬脂酸镁粉末在用于高剪切（HSG）和流化床（FBG）湿法制粒制备的颗粒润滑时的功能。该研究包括在压片过程中评估片剂的压缩力和顶出力以及对压制片剂进行溶出度测试。与用MgSt-B粉末润滑的颗粒相比，两种制粒方法制备的颗粒在用MgSt-V粉末润滑时所需的顶出力显著更低（p < 0.01）。与用MgSt-B粉末润滑的颗粒相比，用HSG方法制备并用MgSt-V粉末润滑的颗粒在生产具有相似重量和硬度的片剂时也需要显著更低的压缩力（p < 0.01）。溶出曲线不受这些差异的影响，并且对于通过相同制粒方法制备并用任何一种硬脂酸镁粉末润滑的片剂来说是相同的。结果表明MgSt-B和MgSt-V粉末的润滑效率之间存在显著差异（p < 0.01），并强调了对MgSt粉末进行功能测试以了解这些差异影响的重要性。
