Structure-Property Relationship of Amorphous Maltitol as Tableting Excipient.

Maltitol shows interesting properties compared with mannitol or sorbitol, two other polyols, which are widely used as a pharmaceutical excipients for tablet compaction. For this study, the properties of an amorphous polyol, maltitol, were investigated using a tablet press simulator. The aim of this study was to evaluate the behavior of amorphous maltitol compared to SweetPearl® P 200, a pure product, and SweetPearl® P 300 DC, a textured crystalline maltitol excipient for direct compression. The physicochemical and pharmacotechnical properties were compared, revealing a major change in properties after amorphization. The study of the tabletability, mean yield pressure, elastic properties, etc. shows that the compression behavior of amorphous powders has been significantly altered. The results showed specific properties of amorphous maltitol with good tabletability at low compaction pressure. The stability of the amorphous and the evolution of its behavior in compression were then studied, showing a direct link between its recrystallization and the change in its properties. The use of a stabilizing agent, maltotriitol, slowed down the recrystallization, maintaining the specific properties of the amorphous material in compression for a longer period of time.