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在双螺杆融颗粒化中解局部热量产生

Niyati Niranjan Kodange¹, Adwait Pradhan¹, Fengyuan Yang²

¹Division of Molecular Pharmaceutics and Drug Delivery, College of Pharmacy, University of Texas at Austin, Austin, TX 78712, USA.

International journal of pharmaceutics

|April 5, 2025

概括

双螺旋化颗粒处理 (TSMG) 使用热量来生长颗粒. 优化工艺参数和粘合剂水平,比如使用5%的基烯基纤维素,可以提高颗粒强度,同时最大限度地减少药物颗粒大小.

科学领域:

制药制造业制药制造业制药制造业
化学工程是化学工程的重要组成部分.
材料科学材料科学材料科学

背景情况:

双螺旋化颗粒 (TSMG) 的颗粒生长受块内粘性和摩擦力产生的热量的影响.
了解局部热生成 (ΔTlocal) 对于优化TSMG工艺及其在制药生产中的应用至关重要.

研究的目的:

调查过程参数和粘合剂度对TSMG期间局部热量产生 (ΔTlocal) 的影响.
评估特定机械能 (SME),DT局部和药物颗粒大小减小之间的关系.
为了确定最佳条件,以实现所需的颗粒强度,最小的药物降解.

主要方法:

作为一种示范药物,使用了类醇 (APAP) 和作为结合剂的KlucelFusionTM X HPC (基基纤维素).
多种工艺参数,包括Q/N比率 (料速率与螺丝速度) 和制块分阶角度.
测量 ΔTlocal, SME 和 APAP 颗粒粒粒后的颗粒大小减小.

主要成果:

Q/N比率和制块的摇摆角度显著影响了 ΔTlocal.
特定机械能 (SME) 与 ΔTlocal 强烈相关;较高的 SME 导致较高的 ΔTlocal.
5%的粘合剂水平达到所需的平板拉伸强度 (> 2 MPa),与10%的粘合剂水平相比,APAP颗粒大小的减少较小.

结论:

优化TSMG过程参数和绑定级别是控制SME和 ΔTlocal.的关键.
在TSMG中较低的粘合剂水平 (5%HPC) 可以产生有效的颗粒和强大的片剂,而药物颗粒大小的减少最小.
这些发现支持使用TSMG来生产强大的药物颗粒,提高药物稳定性.

关键词:

结合剂水平水平的结合剂.填充的程度填充的程度结结块是一个结结块.当地发电热的本地发电.特定的机械能量特定的机械能量双螺丝化颗粒化融技术

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