The current research work was focused on the solubility enhancement of Dolutegravir sodium by Self emulsifying drug delivery system. Dolutegravir sodium is an antiretroviral drug which falls under BCS class II drug having low aqueous solubility and high permeability. The saturation solubility was examined in different excipients utilized in SEDDS such as oils, surfactants and co-surfactants (4:1). Excipients were selected based on the maximum solubility of drug in the excipients and compatible studies. Pseudo ternary plots were constructed to determine the region of self nano emulsification utilizing water titration method. Dolutegravir liquid SEDDS formulations were prepared based on pseudo ternary plot utilizing different proportions of oil (Capryol 90), surfactant (Kolliphor EL), co-surfactant (Lauroglycol FCC). Prepared two Dolutegravir sodium liquid SEDDS formulations were  chosen for  further evaluation  tests   like Dispersibility test  was observed  as  Grade A, Robustness to dilution test was passed, time taken for self-emulsification( 30 seconds), percentage transmittance was  showed as clear emulsions, thermo dynamic stability studies showed that the optimized formulation was thermodynamically stable , Drug loading efficiency was found to be 98.2 , Droplet size analysis was found to be  32.75(d.nm) , PDI (0.296),zeta potential distribution was found to be  -11.9mV ,In-vitro dissolution studies. Among two prepared formulations of Dolutegravir liquid SEDDS CK4L1 (4:6) was considered as optimized formulation as it was shown increased dissolution profile i.e., % drug release (87.53%) compared with that of pure drug Dolutegravir sodium (31.26%). The results demonstrated  that  the solubility of Dolutegravir  sodium liquid SEDDS  was enhanced significantly by 2.8 times compared with that of pure drug.The current examinations show that Dolutegravir liquid SEDDS can be utilized as expected methods for increasing solubility and bioavailability.

KEYWORDS

Dolutegravir sodium, Solubility, Bioavailability, Water titration method, Self Emulsification.