Structure-property relationship of amorphous maltitol as tableting excipient

Oct. 13, 2020, midnight - by Franck Bourduche , Noelia M. Sanchez-Ballester , Bernard Bataille , Philippe Lefèvre , Tahmer Sharkawi

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Maltitol exhibits noteworthy characteristics in comparison to mannitol or sorbitol, two commonly used polyols as pharmaceutical excipients for tablet compaction. In this investigation, the attributes of amorphous maltitol were explored using a tablet press simulator. The objective was to assess the behavior of amorphous maltitol in comparison to SweetPearl® P 200, a pure product, and SweetPearl® P 300 DC, a textured crystalline maltitol excipient designed for direct compression. The comparison of physicochemical and pharmacotechnical properties unveiled significant alterations after the amorphization process. The analysis of tabletability, mean yield pressure, elastic properties, and other parameters demonstrated a substantial modification in the compression behavior of amorphous powders. The findings revealed distinctive properties of amorphous maltitol, showcasing good tabletability at low compaction pressure. Subsequent exploration focused on the stability of the amorphous state and its evolution during compression, establishing a direct correlation between recrystallization and the resultant changes in properties. To mitigate recrystallization, maltotriitol, a stabilizing agent, was introduced. This intervention effectively slowed down the recrystallization process, preserving the specific properties of the amorphous material during compression for an extended duration.

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stability amorphous solid dispersion amorphous state maltitol physicochemical characterizations stylone direct compression stability study physicochemical characterization styl'one evo