Methodologies for Developing Solid Self-Emulsifying Drug Delivery Systems

Lipid based drug delivery (LBDD) is an effective method of improving the solubility of BCS Class-II and Class-IV compounds and the permeability of certain BCS Class III and Class-IV compounds.  Typically, LBDD systems are formulated by dissolving the therapeutic compound in one or more lipids to form a pre-concentrate.  Subsequently, this pre-concentrate forms a drug containing oil in water emulsion in the GI tract through the actions of enzymes and bile salts or by self-emulsification of the lipid components.  Traditionally, the employed lipids have been liquid at room temperature.  Recently, it has become of interest to develop solid LBDD pre-concentrates which can offer certain advantages over liquids, most specifically ease of incorporation into tablets and other solid oral dosage forms.  The formulation of solid LBDD pre-concentrates is not a trivial process as attention needs to be paid to the physical state of both the therapeutic compound and the pre-concentrate lipids, as well as the dispersion of the solid pre-concentrate into an oil in water emulsion in the GI tract, in order to ensure drug delivery.

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