Safari Fatemeh, Goudarzi Azin, Abolghasemi Hossein, Mohammad Hussein Abdelamir, Akrami Mohammad, Mohammadi Saeid, Haririan Ismaeil
School of Chemical Engineering, Alborz Campus, University of Tehran, Tehran 1417935840, Iran.
Department of Biotechnology & Pharmaceutical Engineering, School of Chemical Engineering, College of Engineering, University of Tehran, Tehran 1417935840, Iran.
Polymers (Basel). 2025 Aug 26;17(17):2302. doi: 10.3390/polym17172302.
Significant efforts have been dedicated to developing controlled-release systems for the effective management of colorectal cancer. In this study, a once-daily, delayed-release regorafenib (REG) tablet was fabricated using 3D printing technology for the treatment of colorectal cancer. For this, a hydrogel containing 80 mg of the drug in a matrix of hyaluronic acid, carboxymethyl cellulose, Pluronic F127, and glycerol was prepared to incorporate into the shell cavity of tablet via a pressure-assisted microsyringe (PAM). The shell was printed from an optimized ink formulation of Soluplus, Eudragit RS-100, corn starch 1500, propylene glycol 4000, and talc through melt extrusion-based 3D printing. In vitro release assays showed a drug release rate of 91.1% in the phosphate buffer medium at 8 h and only 8.5% in the acidic medium. Drug release kinetics followed a first-order model. The results showed smooth and uniform layers based on scanning electron microscopy (SEM) and drug stability at 135 °C upon TGA. FTIR analysis confirmed the absence of undesired covalent interactions between the materials. Weight variation and assay results complied with USP standards. Mechanical strength testing revealed a Young's modulus of 5.18 MPa for the tablets. Overall, these findings demonstrate that 3D printing technology enables the precise fabrication of delayed-release REG tablets, offering controlled-release kinetics and accurate dosing tailored for patients in intensive care units.
为有效管理结直肠癌，人们付出了巨大努力来开发控释系统。在本研究中，采用3D打印技术制备了一种每日一次的延迟释放瑞戈非尼（REG）片剂用于治疗结直肠癌。为此，制备了一种水凝胶，其在透明质酸、羧甲基纤维素、普朗尼克F127和甘油的基质中含有80毫克药物，通过压力辅助微注射器（PAM）将其掺入片剂的壳腔中。外壳由Soluplus、Eudragit RS - 100、玉米淀粉1500、丙二醇4000和滑石粉的优化油墨配方通过基于熔融挤出的3D打印制成。体外释放试验表明，在磷酸盐缓冲液介质中8小时药物释放率为91.1%，在酸性介质中仅为8.5%。药物释放动力学遵循一级模型。基于扫描电子显微镜（SEM）的结果显示层光滑且均匀，热重分析（TGA）表明药物在135°C时具有稳定性。傅里叶变换红外光谱（FTIR）分析证实材料之间不存在不期望的共价相互作用。重量差异和含量测定结果符合美国药典标准。机械强度测试显示片剂的杨氏模量为5.18兆帕。总体而言，这些发现表明3D打印技术能够精确制造延迟释放的REG片剂，提供控释动力学和为重症监护病房患者量身定制的准确剂量。
