Fabrication and evaluation of solid self emulsifying drug delivery system of dolutegravir sodium by using adsorption to solid carrier techniques

The objective of this work was to design and characterize liquid and solid self-emulsifying drug delivery systems (SEDDS) for poorly soluble Dolutegravir Sodium. To optimize the composition of liquid Dolutegravir Sodium-SEDDS, solubility tests, pseudoternary phase diagrams, emulsification studies and other in vitro examinations (thermodynamic stability, droplet size and zeta potential analysis) were performed. The central composite design was employed to optimize the formulation variables, Capmul MCM (oil), Tween 80 (surfactant) and Propylene glycol (co-surfactant). Liquid self-emulsifying drug delivery system was appraised for determination of self emulsifying time, globule size and drug release. TEM study confirmed the uniform oil globules of the optimized liquid formulation. The optimized liquid formulation was formulated into free-flowing powder (S-SEDDS) by adsorption on the materials like Aerosil 200, Neusilin US2 and compressed into tablets. The solid state characterization of S-SEDDS powder was performed by using DSC, PXRD and SEM to investigate the physical nature of the drug. Further, the accelerated stability studies for 6 months revealed that S-SEDDS of Dolutegravir Sodium was found to be stable without any significant change in physico-chemical properties. S-SEDDS of Dolutegravir Sodium with improved dissolution profile was successfully prepared by using Neusilin US2 as an adsorbent carrier as compared to marketed sample.