Difference in the lubrication efficiency of bovine and vegetable-derived magnesium stearate during tabletting.
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.
Gupta
Abhay
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.
Hamad
Mazen L
ML
Tawakkul
Mobin
M
Sayeed
Vilayat A
VA
Khan
Mansoor A
MA
D000818:Animals; D002417:Cattle; D019245:Compressive Strength; D054327:Lubricants / Q000494:pharmacology*; D013229:Stearic Acids / Q000494:pharmacology*; D013607:Tablets; D013678:Technology, Pharmaceutical; D014675:Vegetables
D054327:Lubricants; D013229:Stearic Acids; D013607:Tablets; C031183:stearic acid