挤出法3D打印对乙酰氨基酚片的可行性研究

Feasibility study of 3D printing Acetaminophen Tablets by extrusion method

目的研究热熔挤出法3D打印技术制备对乙酰氨基酚片的可行性。方法本文采用将热熔挤出3D打印技术与药物制剂相结合的方法,通过处方筛选选择符合该试验条件的辅料,进行关键参数的初步探索,并选择结果较好的材料进行质量评价。结果利用挤出法3D打印技术成功制备出5种不同辅料的对乙酰氨基酚片,并从中选择结果较好的soluplus为辅料进行质量评价,评价内容包括扫描电镜、热重分析、差示扫描量热分析。结论挤出法3D打印技术可以应用于对乙酰氨基酚片的制备,该技术可以通过计算机程序控制,利用3D打印技术通过仅一个步骤进行片剂的制备,所得产品外表美观、光滑有色泽,API在试验温度下保持热稳定性,并以无定型状态分散于辅料当中。

Objective To study the feasibility of preparing Acetaminophen Tablets by hot melting extrusion 3D printing technology.Methods This paper combines hot melting extrusion 3D printing technology with pharmaceutical preparations,selects the auxiliary materials that meet the experimental conditions through prescription screening,and experiment was carried out to conduct preliminary exploration of key parameters,and the materials with better results were selected for quality evaluation.Results The Acetaminophen Tablets of 5 different excipients were successfully prepared by extrusion 3D printing technology.The quality of soluplus was selected as the auxiliary material for quality evaluation.The evaluation contents included scanning electron microscopy,thermogravimetric analysis and differential scanning calorimetry.Conclusion Extrusion 3D printing technology can be applied to the preparation of acetaminophen tablets.The technology can be controlled by a computer program,using 3D printing technology to prepare the tablet in only one step,the obtained product looks beautiful,smooth and color translated,the API maintains thermal stability at the experimental temperature,and teaches the auxiliary material in an amorphous state.