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Shivangi Saxena* and Vipin Kumar Agrawal


The aim of the study was to design and evaluate a lipid based drug delivery system particularly self microemulsifying drug delivery system in order to improve solubility, dissolution and enhance systemic exposure of a BCS class II anti-leprotic drug, Clofazimine (CLZ). In the present study, solubility of CLZ was determined in various oils, surfactants and cosurfactants to identify the microemulsion components. Pseudoternary phase diagrams were plotted to identify the micro-emulsification existence area. SMEDDS formulation of CLZ was prepared using oil (Ethyl oleate) and a surfactant/ co-surfactant (Tween 80/PEG 400) mixture and was characterized by appropriate studies, viz.,self emulsification, thermodynamic stability test, droplet size measurement, zeta potential, in vitro dissolution, etc. The optimized formulation of SMEDDS comprised of 31.2% oil (ethyl oleate), 51.6% surfactant (Tween 80), and 17.2% co-surfactant (PEG 400). The solubility of CLZ (35 mcg/ml) significantly increased in SMEDDS which in water being 0.3 mcg/ml), which indicates approx. 106 fold enhancement in solubility. The average particle size and zeta potential of SMEDDS containing CLZ was about 82.46nm and -23.3 mV when diluted in water. All the SMEDDS were found to form clear dispersion and none of the formulation showed any drug precipitation, suggesting that developed SMEDDS was stable. The dissolution study in-vitro showed that about 99% of CLZ in SMEDDS could be dissolved in pH 1.2 or pH 6.8 buffer solutions in 30 min, however, less than 30% for crude CLZ in 60 min. Thus, the study illustrated that the developed SMEDDS formulation held great potential as a possible alternative to traditional oral formulations of CLZ.

Keywords: SMEDDS, Phase diagram, Clofazimine.

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