Re-crystallized sucrose (RS) solids grown from the methanol-water solution at 60°C exhibited two endothermic peaks at 150°C and 189°C by differential scanning calorimetry (DSC) at 10°C/min whereas commercial sucrose (CS) displayed only one endothermic peak at 190°C. However, the water content of RS of only 0.03 w/w% measured by Karl Fischer (KF) titrimetry was surprisingly less than the one of CS of 0.49 w/w%. Obviously, the inclusion of water was not a satisfying explanation for the endotherm at 150°C observed for RS. Both powder X-ray diffraction (PXRD) and single-crystal X-ray diffraction (SXD) further suggested the variations of the thermal behavior between RS and CS could be due to the presence of conformational polymorphs about the glycosidic linkage. The two conformational polymorphs were enantiotropically related and gave different solubility curves in water and dissolution profiles for formulated acetaminophen. These phenomena has raised an important issue on the quality control of sucrose and their manufacturing protocol if sucrose was to be developed into added functionality excipients for pharmaceutical formulations in the future.
|Number of pages||6|
|Journal||International Sugar Journal|
|State||Published - Jul 2007|