Optimization of Laponite Nanogel with Curcumin Incorporation: A Quality by Design Approach

To achieve the desired therapeutic effect in vivo, nanogel administered via various routes must overcome multiple barriers, with stability being particularly crucial in the devel-opment of formulations. Developing stable nanogel requires a multi-parameter strategy that focuses on the critical quality attributes (CQAs) influencing stability. This study, grounded in the Quality by Design (QbD) concept and combined with Design of Ex-periments (DoE), developed nanogel of the inorganic material Laponite loaded with curcumin (CUR). By addressing the characteristics and stability challenges of Laponite nanogel, the research identified the CQAs and critical process parameters (CPPs). Through single-factor experiments and response surface methodology (BBD), a design space was established to influence particle size (Ps), drug loading (DL), encapsulation efficiency (EE), and formulation components. The optimal formulation (LAP:CUR:TPGS = 6:2:36.6 mg/10mL) was identified and validated through FTIR, DSC, TEM, drug release, and stability studies. The integration of QbD and DoE significantly reduced trial and error in the development of formulations, enhancing efficiency. Exploring this process contributes to a deeper understanding of the key factors for successful nanoparticle de-velopment and lays the foundation for future integration of AI technology to promote a "first-time-right" drug formulation development model. The graphical abstract of this study is shown in Graphical Abstract.