DEVELOPMENT AND CHARACTERIZATION OF SELF EMULSIFYING DRUG DELIVERY SYSTEMS OF NEXT GENERATION INTEGRASE INHIBITOR: DOLUTEGRAVIR
Abstract
Self-Emulsifying Drug Delivery System (SEDDS) was prepared to improve the oral bioavailability of antiretroviral drug Dolutegravir, a BCS Class II molecule. Dolutegravir is also a substrate for p-glycoprotein (p-GP), which efflux the molecule into intestinal lumen & hence decrease the oral bioavailability. The SEDDS formulation consisted of Dolutegravir, Capmul MCM, Labrasol, Tween 20, Propylene glycol & Transcutol HP. The saturation solubility study of Dolutegravir was conducted in different oils, surfactants and co-solvents. The pseudo-ternary phase diagrams were constructed to identify the self emulsifying regions. The formulation was characterized for droplet size analysis, zeta potential, poly-dispersibility index, assay, impurities and in-vitro dissolution behaviour.
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