Li Jing, Kong Xiangfeng, Chen Hongxia, Lu Mengqiu, Liu Xiaochang, Wang Lijie
School of Pharmacy, Shenyang Medical College, No. 146 Huanghe North Street, Shenyang 110034, China.
Gels. 2025 Aug 24;11(9):677. doi: 10.3390/gels11090677.
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.
纳米凝胶通过多种途径给药，以克服生理屏障并在体内实现所需的治疗效果。然而，需要开发一种稳定的纳米凝胶系统，以在储存后保持其治疗效果。因此，以姜黄素（CUR）为模型药物，采用质量源于设计（QbD）和实验设计（DoE）开发了一种由无机材料（锂皂石）组成的纳米凝胶系统。通过全面的文献综述、单因素实验和Box-Behnken设计（BBD）实验，我们确定了关键质量属性（CQA）和关键工艺参数（CPP），最终获得了最佳配方。将药物载药量（DL）、包封率（EE）、粒径（Ps）和多分散指数（PDI）确定为CQA，并成功制备了最佳配方（LAP:CUR:TPGS = 6:2:36.6；mg；10 mL）。傅里叶变换红外光谱（FTIR）、差示扫描量热法（DSC）和透射电子显微镜（TEM）分析证实了CUR的成功负载，Ps在100nm以内，呈现双相药物释放特性，并在4℃下保持稳定28天。QbD与DoE相结合成功地制备了稳定的CUR-TPGS-LAP纳米凝胶。本研究有助于更好地理解纳米凝胶开发中的关键因素，并为未来整合人工智能技术以促进“一次成功”的药物配方奠定基础，以实现未来人工智能推动的“一站式”药物配方开发模式。
