The properties of taurocholate-lecithin powder (SIF Powder) and the biorelevant media FeSSIF and FaSSIF prepared
from the powder were investigated using various techniques. The powder is stable and shows no change in the physical
or chemical characteristics for at least 12 months in the original container stored at 2-8 degC. FeSSIF and FaSSIF were stable
with respect to hydrolysis for at least 48 h at 37 degC. Oxidation in FeSSIF was detected at a very low level and to an even
lower extent in FaSSIF. FaSSIF comprises a complex mixture of colloidal aggregates including rod-like, spherical, disc-like
mixed micelles and vesicles. Consistent particle size was achieved by equilibrating the medium at room temperature (RT)
after preparation. In comparison, FeSSIF only comprises smaller mixed micelles and requires no equilibration. The dissolution
rates of three poorly water-soluble model drugs tested in FaSSIF media differing in average particle size controlled at
30 nm and 50 nm were not statistically different. However, differences in the average particle size can affect visual clarity:
FaSSIF is generally slightly opalescent above an average size of approximately 50 nm and appears clear below approximately
50 nm. Challenge tests showed that FaSSIF is more susceptible to microbial spoilage than FeSSIF. Reproducible
FeSSIF and FaSSIF can be made conveniently from the powder by employing standard preparation methods at RT.
Journal:
dissolutiontechAugust 2010 Volume 17 Issue 3
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