How Excipient Type Influences Self-Emulsifying Drug Delivery

Abstract

Most published estimates state that greater than 70% of drugs in the small-molecule pipelines are considered poorly water soluble. Because the human body requires that a drug essentially be solubilized in an aqueous environment, this poor water solubility poses an enormous challenge to effective drug delivery. [...]techniques such as amorphous solid dispersions (ASDs), which are made using hot melt extrusion and spray drying, and lipid-based drug delivery systems (LBDDS) are effectively used in the majority of the poorly water-soluble drugs brought to market. [...]the surfactant phase was designed. Testing of these formulations can be challenging, because in a standard dissolution bath with UV filter it is often too difficult to parse the API concentration from the droplets, micelles, and other phases in the bath. [...]it is recommended that formulators test these using lipolysis, membrane-based absorption models (macroFlux, Pion) or cell-based methods, such as Caco-2.