Evaluation of physicochemical properties on the blending process of pharmaceutical granules with magnesium stearate by thermal effusivity sensor

Magnesium Stearate (MgSt) is a widely used lubricant for preventing tablet compression trouble. It is known that the powder characteristic of MgSt is different among MgSts manufactured by different methods and conditions. These differences affect blending efficiency with pharmaceutical additives. The purpose of this study is to evaluate the physicochemical properties of MgSt by thermal effusivity sensor for in-process monitoring of powder blending. MgSts having different physicochemical properties and granulated sugar spheres were used for model excipients. V-blender was used for powder blending. Thermal effusivity values of each of the ingredients in the blend were measured using one of the sensors prior to placing the ingredient in the blender. The effect of magnesium stearate addition to uniform ingredients can be clearly identified using the sensors. Compared to effusivity data and powder density, effusivity data correlated with the powder characteristics of magnesium stearate. These results suggested that effusivity can be used for end point detection of blending process for various magnesium stearates with sugar sphere. When various magnesium stearates were added to the granule, required time for achieving homogeneous powder blend was different. Blending behavior would be affected by the physicochemical characters. Blend uniformity and blended states of granules containing magnesium stearate can be detected nondestructively without intricate sampling process. Thermal effusivity sensors are an efficient tool to monitor the real time blending behavior of pharmaceutical ingredients.

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