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2-(10,11-Dihydro-10-oxodibenzo [b,f] thiepin-2-yl) propionic acid (Zaltoprofen) is classified as a BCS class II anti-inflammatory drug, having low solubility and less bioavailability. This study describes the development and characterization of self-micro emulsifying drug delivery system (SMEDDS) of the poorly water-soluble compound Zaltoprofen that resulted in improved aqueous solubility, dissolution, and  in-vivo  oral absorption. The solubility of Zaltoprofen was determined in various vehicles, including oils, surfactants, and co-surfactants. Pseudo-ternary phase diagrams were constructed to identify the most efficient self-emulsification region. The optimized SMEDDS used for Zaltoprofen formulations contained 80% mixtures of surfactant:co-surfactant Labrasol:Cremophor RH 40 (4:1), and 20% of oil, ethyl oleate. Further, SMEDDS was characterized by particle size, zeta potential, dissolution studies, and anti-inflammatory activity. The Zaltoprofen-SMEDDS rapidly formed fine oil-in-water microemulsion, which was thermodynamically stable, having an average particle size of 451.3 ± 3.2 nm. The  in-vitro  dissolution rate of Zaltoprofen from SMEDDS was significantly higher ( p &lt;.01) compared to marketed tablets in 0.1N HCL and pH 4.5 buffer. SMEDDS showed highly significant inhibition ( p &lt;.01) of inflammation in rat paw edema compared to the drug. The study demonstrated that the self-micro emulsifying system poses a promising strategy for developing hydrophobic compounds with low oral bioavailability.

Formulation, characterization, and in-vivo evaluation of Zaltoprofen self-microemulsifying drug delivery system