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粉末床印刷板块的表面工程方法,以优化外部光滑,并促进不同涂料的应用

Khanh T T Nguyen¹, Daan Zillen¹, Franca F M van Heijningen²

¹Department of Pharmaceutical Technology and Biopharmacy, University of Groningen, 9700 RB Groningen, The Netherlands.

|September 28, 2023

概括

研究人员开发了一种生产粉床印刷 (PBP) 片的新方法,可以直接应用pH取决于pH值的涂层. 这一进步确保了封装牛肠酸酶 (BIAP) 的稳定性,用于向药物输送.

科学领域:

制药技术制药技术制药技术
药物输送系统药物输送系统
生物制药配方生物制药配方

背景情况:

之前试图用ColoPulse涂层覆盖粉末床印制 (PBP) 片,以准牛肠性酸酶 (BIAP) 的内脏-结肠向 (ileo-colonic targeting),由于表面粗度高,需要额外的次层涂层.
开发一种允许直接涂层应用的PBP平板生产方法对于简化制造过程和提高效率至关重要.

研究的目的:

确定含有BIAP的PBP片的生产方法,允许直接应用没有子涂层层的涂层系统.
评估优化PBP生产参数和乙醇蒸汽处理对平板表面光滑性和可涂性的影响.
为了确认在涂层过程和储存后,在胰岛素玻璃中封装的BIAP的稳定性.

主要方法:

优化粉末床打印 (PBP) 参数,包括粘合剂含量和打印层高度,以减少平板电脑表面的粗度.
应用乙醇蒸汽处理以进一步提高PBP片的表面光滑度.
在修改后的PBP片上直接涂上ColoPulse (针对伊利欧结肠) 或肠道 (针对上肠) 涂层.
进行了体外释放测试,以评估药物释放概况.
在2-8°C保存2个月的BIAP封装片,并评估酶活性.

主要成果:

印刷参数和乙醇蒸汽处理的组合改变显著改善了PBP平板表面的光滑性,使直接涂层应用成为可能.
在体外释放试验证实了ColoPulse涂层片所需的乳腺结肠释放和肠膜涂层片的上肠释放.
在冰箱储存2个月后,包装在胰岛素玻璃中的BIAP保持了高酶活性 (>95%),而涂层过程没有损失.

结论:

成功开发了PBP片的生产方法,其表面适合直接应用ColoPulse或肠道涂层.
优化的PBP工艺保持了封装BIAP的稳定性和高酶活性.
这项研究展示了一种用于直接涂覆PBP片的新方法,增强了像BIAP这样的生物制药的输送.

关键词:

通过3D打印打印3D打印.这就是ColorPulse的意义.生物学的生物学.有控制释放的释放.薄膜涂层是一种薄膜涂层.这是一种配方配方.阴茎 - 结肠向向.个性化医疗是个性化的医疗.粉末床印刷粉末床印刷粉末床印刷表面分析表面分析

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