Dissolution Rate Enhancement of Dolutegravir Sodium Through Nanosuspension Technology Using 3² Factorial Design

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Dolutegravir Sodium is a potent antiretroviral medication used in the treatment of HIV. It is a BCS Class II compound and is practically insoluble in the normal gastric pH range. This study aimed to discover and optimize the operational and formulation factors affecting the drug characteristics. 3² factorial design was used for the study. PVP K30, Polyvinyl Alcohol, Polxammer 407, and Polxammer 188 were used in the preparation of nanosuspension. The formulation variables tested were the polymer concentration, whereas the manufacturing variable was homogenization speed. Particle size and saturation solubility were the two responses evaluated in this study. The results of the analysis of variance indicate that the polymer concentration and homogenization speed significantly affect the saturation solubility and particle size of the nanosuspension. The contour plot and resulting polynomial formula help to estimate the values of the chosen independent factors to develop the best nanosuspension formulations with the required characteristics.