Aim:

The present study is focused to develop and optimize nanoparticulate delivery system for two antidiabetic drugs; Sitagliptin Phosphate (SP) and Empagliflozin (EMP) of BCS class III drugs as a single dosage form using Box Behnken Design (BBD) and desirability function in lieu of superior permeability.

Materials and Methods:

Nanoparticles (NPs) were prepared using natural polymer Chitosan (CS) by ion gelation technique. BBD was employed to attain optimized formulation via responses (particle size and % entrapment efficiency). The optimized formulation was assessed for various parameters viz. and evaluated for particle size, entrapment efficiency, in vitro release kinetics and morphology through Scanning Electron Microscopy (SEM).

Results:

The responses showed a noteworthy influence of the formulation composition with a significant effect (p<0.05). Leveraging the power of desirability function, the most favourable formulation was handpicked and thereafter subjected to reformulation. The findings demonstrated chitosan-based nanoparticles with remarkable stability, boasting a zeta potential registering at +30.5 mV, featuring petite particles at 89.43 nm and an impressive entrapment efficiency of 80.99%. The optimized preparation exhibited uniformity, stability and consistency between the observed and predicted responses.

Conclusion:

The efficacy of SP-EMP-CS nanoparticles in enhancing the bioavailability of poorly permeable drugs, combined with the utilization of BBD and desirability function, has provided a valuable framework for optimizing SP-EMP-CS nanoparticulate formulation. This approach has allowed for a comprehensive understanding of the impact of various independent variables on formulating an optimized SP-EMP-CS nanoparticulate system with superior responses. In summary, using Box Behnken design and desirability function, the research successfully developed a Nanoparticulate delivery system for SP and EMP, providing a promising approach to increase drug bioavailability and potentially improve diabetic therapy outcomes like improved glycemic control, enhanced patient adherence etc.