Solubility enhancement of Ebastine by Self-Nano-Emulsifying approaches

Oral route is the easiest and most convenient way of noninvasive administration. Approximately, 40% of new chemical entities exhibit a poor aqueous solubility and present a major challenge to modern drug delivery systems which leads to a poor oral bioavailability, high intra- and intersubject variability, and lack of dose proportionality. Lipid-based drug delivery systems have gained considerable interest. Self Nano Emulsifying Drug Delivery Systems (SNEDDS) are defined as isotropic mixtures of natural or synthetic oils, solid or liquid surfactants, or alternatively, one or more hydrophilic solvents and cosolvents/surfactants that have the ability of forming fine oil-in-water (o/w) micro emulsions upon mild agitation followed by dilution in aqueous media, such as GI fluids. SNEDDS spread readily in the GI tract, and the digestive motility of the stomach and the intestine provides the agitation necessary for self-emulsification.Because of self-emulsification in the stomach, the drug is presented as small droplets of oil (<5 ¿m) leading to improved drug dissolution through providing a large interfacial surface area for partitioning of the drug between the oil and GIT fluid.