Effect of Magnesium Stearate Mono- and Dihydrate Dispersibilities on Physical Properties of Tablets

Chemical & Pharmaceutical Bulletin
Koji YamamotoEtsuo Yonemochi

Abstract

Magnesium stearate (MgSt), an essential lubricant in the manufacturing of tablets, is available in several hydrate forms with different qualities that affect the physical properties of tablets. This study examined MgSt mono- and dihydrates, and their effects on tablet dissolution, disintegration, and hardness. These effects were examined in terms of surface free energy and dispersibility. Dissolution, disintegration, and hardness were evaluated for tablets manufactured from powder mixtures of each MgSt hydrate form and other components, including ethenzamide as an active ingredient, using different mixing times. The surface energy was evaluated for MgSt mono- or dihydrate powder mixtures with a surface tensiometer. For dispersibility, the adhesion states of MgSt hydrates to other components were visually observed via near-infrared (NIR) chemical imaging. The dispersion behavior of MgSt hydrates was examined by quantitative evaluation of skewness and kurtosis of histograms, based on NIR images, and domain size estimated from their binary images. It was found that changes in those parameters related to dispersibility and dissolution differed between MgSt hydrates. This suggests that the quantitative determination of dispersibilit...Continue Reading

References

Apr 1, 1978·Journal of Pharmaceutical Sciences·T A Iranloye, E L Parrott
Dec 1, 1992·Journal of Pharmaceutical Sciences·U I LeinonenE S Laine
Apr 4, 2003·International Journal of Pharmaceutics·Han Young ChungWoo Sik Choi
Dec 3, 2014·Journal of Pharmaceutical and Biomedical Analysis·Mathieu BoiretJean-Michel Roger

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