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三酸盐四酸盐TB作为填充剂,用于直接压缩矿床

Maike Hafels¹, Amelie Mattusch², Karl G Wagner¹

¹Department of Pharmaceutics, University of Bonn, Gerhard-Domagk-Str. 3, Bonn, 53121, Germany.

AAPS PharmSciTech

|February 20, 2026

概括

三酸四水合物 (TCC TB) 显示出作为儿科小婴儿直接压缩辅助剂的前景. 与其他填充剂相比,它在分解,内容均性和抗拉强度方面提供了卓越的性能.

科学领域:

制药科学制药科学
材料科学材料科学材料科学

背景情况:

小盘 (直径≤3毫米) 是理想的儿科使用,提供更容易吞和精确的剂量.
通过直接压缩制造小平板电脑的挑战包括满足对流动性,内容均性,分解性和可口性严格的辅助剂要求.

研究的目的:

评价三酸盐四水合物 (TCC TB) 作为一种易碎的直接压缩辅助剂,用于小片剂制剂.
为了比较TCC TB的性能与常见的填充剂,如Tablettose® 80,galenIQTM 721,Vivapur® 102和Vivapur® 200的性能.

主要方法:

使用压缩模拟器制造的小片 (8毫克) 含有富洛塞米德 (6.25%或12.5%的药物负载).
辅助剂的性能是根据流动性,含量均性,分解时间和拉伸强度来评估的.

主要成果:

在分解时间,内容均性和抗拉强度方面,TCC TB表现出卓越的性能.
galenIQTM 721由于粘着而表现出平板问题,而Tablettose® 80未能满足内容均性和抗拉强度标准.
维瓦普尔®102和维瓦普尔®200显示了与TCC结核病相似的结果.

结论:

三酸四水合物 (TCC TB) 是用于工业规模小型平板电脑生产的高潜力辅助剂.
对于儿科微型小药片配方,TCC TB 与传统的填充剂相比具有优势.

关键词:

直接压缩直接压缩.迷你小子迷你小子儿科配方儿科配方儿科配方三酸酸盐是一种三酸盐.

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