Optimization and Formulation of Emtricitabine-Loaded Liposomes Using a Box-Behnken Design

Objective: The goal of this study was to use a Quality by Design (QbD) approach to create and improve liposomal formulations of Emtricitabine, an anti-HIV drug, to make it better at trapping other substances. Methods: A Box-Behnken Design (BBD) with three factors and three levels was used to systematically look at how the independent variables- Soy Lecithin (60–70%), Cholesterol (20–30%), and Palmitic Acid (5–10%)—affected the dependent variable, Entrapment Efficiency (EE %). We made and tested fifteen different formulas. Results: The statistical analysis of the BBD indicated that a Linear model was sufficient to describe the design space, as higher-order models were not significant. The ANOVA for the linear model yielded an F-value of 1.00 (p=0.4289), signifying that the model was not significant in relation to noise. None of the individual factors (Soy Lecithin, p=0.5831; Cholesterol, p=0.2393; Palmitic Acid, p=0.3099) demonstrated a statistically significant effect on EE within the studied ranges. However, the lack of fit was non-significant (p=0.9515), confirming the model's adequacy. A confirmation batch prepared with 70% Soy Lecithin, 20% Cholesterol, and 10% Palmitic Acid yielded an EE of 66.96%, which was within the 95% prediction interval (53.21% - 81.30%) of the predicted value (67.25%). Conclusion: Liposomal formulation of Emtricitabine was optimised and prepared with significant entrapment efficiency, which made possible to test it further through in vitro and in vivo studies. Keywords: Emtricitabine, Liposomes, Box-Behnken Design, Entrapment Efficiency, Quality by Design, Optimization, Anti-HIV.