Conclusions

The clear relationship that exists between the GI absorption of many poorly water-soluble, hydrophobic drugs and the solubilization afforded by lipid-based formulations is well accepted by the scientific community. In addition, the frequently observed enhancing effect of the postprandial state on poorly-soluble drug bioavailability suggests important roles for endogenous lipid and surfactant substances and the GI lipid handling pathways in determining the absorption of these drugs. The dynamic lipolysis model described in this chapter was developed to expand upon the utility of earlier biorelevant dissolution media by attempting to more accurately reproduce the process of GI lipid digestion in vitro. Although this technique is relatively unexplored, it has shown great promise as a rapid, cost-effective model for studying and optimizing the performance of lipid-based formulations in vivo as well as for assessing their impact on mitigation of positive food effect seen with many poorly water-soluble drugs.

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