Abstract
Lactulose (4-O-O-D-@aCtOpyranOSyl-D-fructose) was synthesized by Montgomery and Hudson [ 1] in 1930. Its physiological significance as a growth-promoting factor for Si$dobacterium (Bifidus Factor) was discovered by Petuely [ 21 in 1957. Bifidobacterium is a typically beneficial genus of the intestinal microflora and has useful functions for the host. Lactulose is now widely used as a Bifidus Factor in food, and as a remedy for the treatment of hepatic encephalopathy and chronic constipation in many countries of the world. Lactulose was crystallized first from alcohol solution as the anhydride [ 11. In 1992, Jeffrey et al. 131 examined lactulose trihydrate that had been crystallized from aqueous solution. The crystal structure and NMR analysis of lactulose trihydrate revealed that it was comprised only of /3-furanose, whereas lactulose anhydride showed the presence of /3furanose, a-furanose, and P-pyranose in the ratio of 75:10:X [ 41. Because lactulose trihydrate has been reported only recently, its physicochemical properties are not known in detail. The solubility of lactulose in water at 30, 60, and 90°C was reported by Oosten [ 51 and it showed a high solubility of above 76% w/w. However, information concerning the solubility profile of lactulose in aqueous solution at temperaturesbelow 30°C is not available. Since pharmaceutical products consisting of lactulose solutions with high lactulose concentrations are marketed worldwide, it is worthwhile to obtain further solubility information. This study examines the solubility of the crystal form of lactulose in aqueous solution at temperatures below 30°C.
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