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双螺旋融颗粒化Eudragit® FS100:优化无涂层延迟释放矩阵片,使用HPMC K4M调制

Indrajeet Karnik¹, Prateek Uttreja¹, Nagarjuna Narala¹

¹Department of Pharmaceutics and Drug Delivery, School of Pharmacy, The University of Mississippi, University, MS 38677, USA.

International journal of pharmaceutics

|October 30, 2025

概括

这项研究开发了一种可扩展的,无涂层的延迟释放片,使用双螺丝化颗粒剂. 优化的配方在没有复杂的制造工艺的情况下实现了所需的药物释放概况.

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
材料科学材料科学材料科学

背景情况:

传统的延迟释放配方通常需要诸如涂层等多步骤的过程,增加复杂性和成本.
开发可扩展,高效的方法来实现特定的药物释放概况对于制药制造至关重要.
矩阵平板技术提供了可控释放的潜力,但需要仔细优化聚合物系统和处理参数.

研究的目的:

开发一种可扩展的,无涂层的延迟释放矩阵片,使用双螺丝化颗粒剂 (TSMG).
为控制药物释放优化关键的配方变量 (药物负载,螺丝转速,HPMC度).
调查开发的配方的药物释放机制和物理化学特性.

主要方法:

双螺旋化颗粒制剂 (TSMG) 用于药片配方.
使用中央复合设计 (CCD) 来优化药物负载,螺丝转速和基甲基纤维素K4M (HPMC) 度.
在pH 1.2和pH 7.4的体外药物释放研究中,进行了动力分析 (Korsmeyer-Peppas模型),凝厚度,胀,侵蚀,显微镜,PXRD,DSC,FTIR和稳定性测试.

主要成果:

优化的配方 (30%药物负载,20rpm,12.2%HPMC) 在酸性条件下在2小时内释放的药物<10%,在肠道条件下释放>85%.
药物释放遵循Korsmeyer-Peppas模型 (R2=0.9826,n=1.132),表明超级案例II运输是由聚合物放松和侵蚀驱动的.
物理化学分析证实了水凝屏障的形成,部分无形化,组件之间没有化学相互作用,稳定性良好.

结论:

使用TSMG.成功开发了一种新的,可扩展的,无涂层的延迟释放矩阵片.
该配方强大的延缓释放特征归因于pH响应性和pH独立性聚合物的相互作用以及受控的膨胀侵蚀行为.
这种方法提供了一种有效的替代传统涂层方法,以实现所需的药物释放特性.

关键词:

没有涂层的延迟释放.设计实验的设计.欧德拉吉特FS100 FS100的使用情况超级案例II 交通运输膨胀侵蚀的动态双螺丝融化颗粒化技术这是一种pH值依赖的聚合物.

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