Partial Solubility Parameters of Lactose, Mannitol and Saccharose Using the Modified Extended Hansen Method and Evaporation Light Scattering Detection.

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The modified extended Hansen method was tested for the first time to determine partial solubility parameters of non-polymeric pharmaceutical excipients. The method was formerly tested with drug molecules, and is based upon a regression analysis of the logarithm of the mole fraction solubility of the solute against the partial solubility parameters of a series of solvents of different chemical classes. Two monosaccharides and one disaccharide (lactose mononydrate, saccharose and mannitol) were chosen. The solubility of these compounds was de-termined in a series of solvents ranging from nonolar to polar and covering a wide range of the solubility parameter scale. Sugars do not absorb at the UV-vis region, and the saturated solutions were assayed with a recent chromatographic technique coupled to an evaporatiev light scattering detector. This technique was suitable to determine the concentration dissolved in most solvents. The modified extended Hansen method provided better results than the original approach.The best model was the four parameter equation, which includes the dispersion δd, dipolar δp, acidic δa and basic δb partial solubility parameters. The partial solubility parameters obtained, expressed as MPa1/2, were δd=17.6, δp=28.7, δh=19, δb=14.5, δb=12.4, δT=32.8 for lactose, δd=16.2, δp=24.5, δh=14.6, δa=8.7, δb=12.2, δT=32.8 for mannitol and δd=17.1, δP=18.5, δh=13, δa=11.3, δb=7.6, δT=28.4 for saccharose. The high total solubility total solubility parameters δT obtained agree with the polar nature of the sugars. The dispersion parametes δd are quite similar for the three sugars indicating that the polar δp and hydrogen bonding parameters (δh, δa, δb) are responsible for the variation in the total solubility parameters δT obtained, as also found for drugs. The results suggest that the method could be extended to determine the partial solubility parameters of other non-polymeric pharmaceutical excipients.

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