王珊珊, 韩晓璐, 梁恩, 李聪慧, 刘春艳, 李明媛, 王增明, 郁彭, 郑爱萍. 3D打印酒石酸美托洛尔咀嚼片的制备及打印工艺优化J. 药学学报, 2023, 58(9): 2811-2817. DOI: 10.16438/j.0513-4870.2023-0143
引用本文: 王珊珊, 韩晓璐, 梁恩, 李聪慧, 刘春艳, 李明媛, 王增明, 郁彭, 郑爱萍. 3D打印酒石酸美托洛尔咀嚼片的制备及打印工艺优化J. 药学学报, 2023, 58(9): 2811-2817. DOI: 10.16438/j.0513-4870.2023-0143
WANG Shan-shan, HAN Xiao-lu, LIANG En, LI Cong-hui, LIU Chun-yan, LI Ming-yuan, WANG Zeng-ming, YU Peng, ZHENG Ai-ping. Preparation of 3D printed metoprolol tartrate chewable tablets and optimization of printing processJ. Acta Pharmaceutica Sinica, 2023, 58(9): 2811-2817. DOI: 10.16438/j.0513-4870.2023-0143
Citation: WANG Shan-shan, HAN Xiao-lu, LIANG En, LI Cong-hui, LIU Chun-yan, LI Ming-yuan, WANG Zeng-ming, YU Peng, ZHENG Ai-ping. Preparation of 3D printed metoprolol tartrate chewable tablets and optimization of printing processJ. Acta Pharmaceutica Sinica, 2023, 58(9): 2811-2817. DOI: 10.16438/j.0513-4870.2023-0143

3D打印酒石酸美托洛尔咀嚼片的制备及打印工艺优化

Preparation of 3D printed metoprolol tartrate chewable tablets and optimization of printing process

  • 摘要: 随着儿童个性化药物需求的不断增长, 开发儿童使用的个性化制剂尤为重要。本研究以酒石酸美托洛尔为模型药, 利用半固体挤出型(semi-solid extruded, SSE) 3D打印技术开发适合儿童的可自动化分剂量的3D打印酒石酸美托洛尔咀嚼片。本研究基于质量源于设计理念, 以明胶为基质制备了打印性良好的半固体材料, 借助计算机辅助设计构造3D模型并进行片剂打印, 对关键打印参数进行考察及优化, 确定了最终的打印工艺参数: 打印温度为35~37 ℃, 打印速度为25 mm·s-1, 填充率为15%, 外轮廓层数为2。随后, 对打印工艺进行验证, 得到了剂量与模型层数之间的线性关系。最后, 与传统分剂量的市售片剂进行对比, 3D打印咀嚼片在外观, 剂量准确度, 顺应性等方面均较优。本研究成功制备了性能良好的3D打印酒石酸美托洛尔咀嚼片, 解决儿童患者的个性化用药需求。

     

    Abstract: With the growing demand of personalized medicine for children, it is especially important to develop medicines for children. In this study, using metoprolol tartrate as model drug, we developed 3D printed chewable tablets suitable for children with automated dosage distribution using semi-solid extruded (SSE) 3D printing technology. Based on the quality by design concept, this study prepared a semi-solid material with good printability using gelatin as the substrate, constructed 3D models and printed tablets with the aid of computer-aided design. The printing parameters were optimized and determined as follows: print temperature of 35-37 ℃, print speed of 25 mm·s-1, fill rate of 15%, and number of outer profile layers of 2. Subsequently, the printing process and the quality uniformity of the tablets were verified, and a linear relationship between the dose and the number of model layers was obtained. Finally, 3D printed chewable tablets were superior in terms of appearance, dose accuracy and compliance compared with traditional split-dose commercially available tablets. In this study, 3D printed metoprolol tartrate chewable tablets with good performance were successfully prepared to address the personalized medication needs of pediatric patients.

     

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