DefinePK

Abstract

Background: Self-emulsifying drug delivery systems (SEDDs) have emerged as a promising approach to improve the solubility and bioavailability of poorly water-soluble drugs like Nateglinide (NTG). Optimization of formulation variables is essential for enhancing performance attributes such as dissolution rate and particle size.
Objective: To systematically investigate the primary, interaction, and quadratic effects of formulation variables on the performance of NTG-loaded SEDDs using a Box-Behnken Design (BBD).
Methodology: A 15-run BBD with three factors and three levels (3³), including three center point replicates, was employed to analyze the impact of oil (Capryol 90), surfactant (Tween 80), and co-surfactant (PEG 400) as independent variables. Dependent variables were dissolution at 5 and 10 minutes and micelle particle size. Regression analysis, ANOVA, and desirability functions were used for model validation and optimization.
Results: Significant main and interaction effects of formulation variables were observed. The optimized formulation comprised 50.82 mg (10.15% w/w) oil, 250 mg (49.92% w/w) surfactant, and 200 mg (39.93% w/w) co-surfactant, achieving 91.0% dissolution after 5 minutes, approximately 100.0% dissolution after 10 minutes, and a micelle size of 49.23 nm. Predicted and experimental values were closely aligned, confirming model reliability.
Conclusion: The Box-Behnken Design effectively elucidated the relationships among formulation variables and enabled efficient optimization of NTG-loaded SEDDs, reducing time and labor while maximizing performance parameters