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Magnesium stearate surface coverage on tablets and drug crystals: Insights from SEM-EDS elemental mapping

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We propose the utilization of scanning electron microscopy-based energy dispersive X-ray spectroscopy (SEM-EDS) as a versatile tool for quantifying surface area coverage (SAC) by magnesium stearate (MgSt) on pharmaceutical tablets and particles. Our approach involves rapid elemental mapping followed by SAC quantitation through image analysis. This study, conducted on a multi-component system, primarily focused on active pharmaceutical ingredient (API) crystals for particle-level mapping. For both tablets and API particles, the calculated SAC against MgSt loading demonstrated a positive linear correlation across the examined range of MgSt levels. Notably, on the tablet surface, MgSt exhibited a preferential concentration at or in close proximity to grain boundaries, supporting the notion of compression-driven migration and relocation of MgSt within the tablet. Conversely, on the particle surface, discrete aggregates of MgSt were observed, deviating from the widely accepted phenomenon of a thin lubricant film formation around host particles. The discussion delves into the detailed considerations of selecting appropriate SEM-EDS operating conditions and the challenges encountered in mapping particle surfaces.
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