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Understanding the Multidimensional Effects of Polymorphism, Particle Size and Processing for D-Mannitol Powders

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This study investigated the influence of polymorphic form, particle size, and processing of mannitol on the mechanical properties of solid oral dosage forms. The particle and powder properties of spray granulated β D-mannitol, β D-mannitol, and δ D-mannitol were systematically examined in terms of their manufacturability. D-mannitol, a commonly used excipient in pharmaceutical formulations, can crystallize into three polymorphic forms, with β being the thermodynamically most stable and δ a kinetically stabilized polymorph. The analysis encompassed a comprehensive evaluation of the powders as initial materials and their corresponding roller compacted granules. This approach aimed to unveil the multidimensional effects of powder and granule characteristics, including polymorphic form, particle size, and preprocessing, on the mechanical properties of the resulting tablets. In both direct compression and after roller compaction, the δ polymorph exhibited superior tableting properties compared to β mannitol but was surpassed by spray granulated β mannitol. This observation could be primarily attributed to the higher specific surface area, resulting in increased bonding area and more interparticle bonds within the tablet. Consequently, the study demonstrated that surface characteristics and preprocessing can exert a greater influence than polymorphism on the manufacturability of oral solid dosage forms.
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