Box Behnken Design: Unleashing the Potential of Desirability Function for Enhanced Permeability of Antidiabetic Nanoparticles

Indian Journal of Pharmaceutical Education and Research

  • Akanksha Dwivedi2Department of Pharmacy, Acropolis Institute of Pharmaceutical Education and Research, Indore, Madhya Pradesh, INDIA.
  • Rajesh Sharma1Department of Pharmacy, School of Pharmacy, D.A.V.V, Takshshila Campus, Indore, Madhya Pradesh, INDIA.

Volume 59 Issue 2s Pages s494-s507

DOI: 10.5530/ijper.20255506

Abstract

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.

Keywords

  • Box-Behnken design
  • Desirability function
  • Optimization
  • Chitosan-based nanoparticles
  • Sitagliptin phosphate
  • Empagliflozin
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