It is a fact that type II Diabetes remains a major global health problem affecting an estimated 422 million people across the globe. The International Diabetes Federation foresees that this number will continue to rise. There are, however, numerous weaknesses of the classic antidiabetic oral agents. Such limitations are due to lack of water solubility, availability in the body in an unpredictable manner, necessity of high dose intake. Which in turn affects patient compliance and the effectiveness of the therapy. This research utilized both Quality-by-Design (QbD) methodology and Response Surface Methodology (RSM) for the design and optimization of polymeric nanoparticles loaded with glipalamide, a BCS Class II antidiabetic drug. The work addresses a need and provides for the definition of Quality Target Product Profile (QTPP) and Critical Quality Attributes (CQAs) such as particle size, polydispersity index, zeta potential and entrapment efficiency as the primary optimization tasks. For the purpose of studying the effects of three critical material properties mentioned earlier, namely, polymer concentration (50-150 mg), surfactant concentration (0.5-1.5% w/v) and type and intensity of homogenisation (8000-15000 rpm), a Box-Behnken design containing 17 scans was introduced. Upon optimization, the polymeric carrier in its formulated nano range exhibited a tibia lotion for patients of mean volume should have size average of 186.4 ± 5.2 nm and a value of 0.198 ± 0.02 for polydispersity index, -28.6 ± 1.8 mV and entrapment efficiency of 82.4 ± 2.1%. Another vital statistical point was further confirmed by ANOVA which confirmed the model fit to be valid with a very minimal p-value (p < 0.0001) and all precision ratios were greater than 15.0 as recommended for responses. The use of QbD technique in optimizing the designed Nano formulation resulted in a significant feature in the developed formulation as it extended the release of the drug for over 24 hours following Higuchi kinetics which is a critical feature in new antidiabetic drug delivery systems.
Keywords: Quality-by-Design, Box-Behnken Design, Response Surface Methodology, Polymeric Nanoparticles, Glibenclamide, Antidiabetic Formulation, Critical Quality Attributes
How to cite this article:Kumar I, Satkar SS, Sharma D, Tyagi N, Chakraborty T, Bhardwaj A., Statistical Optimization and Quality-by-Design of Nanotechnology-Based Antidiabetic Formulations .Int J Drug Deliv Technol. 2026;16(1s): 994-1010; DOI: 10.25258/ijddt.16. 994-1010