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

Abstract

Nanogel is administered via various routes to overcome physiological barriers and achieve the desired therapeutic effect in vivo. However, developing a stable nanogel system is required to retain its therapeutic efficacy after storage. Therefore, a nanogel system composed of inorganic material (Laponite) was developed using Quality by Design (QbD) and Design of Experiments (DoE), using curcumin (CUR) as a model drug. Through a comprehensive literature review, single-factor experiments and Box-Behnken Design (BBD) experiments, we identified the CQAs and critical process parameters (CPPs), ultimately obtaining the optimal formulation. The DL, EE, Ps and PDI were determined as the CQAs and the optimal formulation was successfully prepared (LAP:CUR:TPGS = 6:2:36.6; mg;10 mL). FTIR, DSC and TEM analyses confirmed the successful loading of CUR, with a Ps in100nm, exhibiting biphasic drug release characteristics and maintaining stability for 28 days at 4 °C. QbD combined with DOE successfully facilitated stable CUR-TPGS-LAP nanogels. This study helps to better understand the critical factors in the development of nanogels and lays the foundation for the future integration of AI technology to promote a "first-time-right" drug formulation for future AI-promoted 'one-stop' drug formulation development model.