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微晶纤维素球体在装有可塑化剂时的可塑性增加

Artūrs Paulausks¹, Tetiana Kolisnyk^2,3, Valentyn Mohylyuk¹

¹Leading Research Group, Faculty of Pharmacy, Riga Stradiņš University, 21 Konsula Str., LV-1007 Riga, Latvia.

|July 27, 2024

概括

将水和糖醇等增塑剂添加到微晶纤维素 (MCC) 球体中,可以显著提高其可塑性. 这种修改降低了平均产量压力 (Py),减轻了制药配方中压缩压力的不良影响.

科学领域:

材料科学材料科学材料科学
制药技术制药技术制药技术
化学工程是化学工程的重要组成部分.

背景情况:

在制药制造过程中压缩压力会导致药物多态,碎片化和颗粒完整性的损失.
增强可塑性的助剂对于最小化这些不良的压缩诱导效应至关重要.
微晶纤维素 (MCC) 是一种常见的辅助剂,其可塑性可以被修改.

研究的目的:

通过加入增塑剂来增强微晶纤维素 (MCC) 的可塑性.
通过可塑化来降低MCC的平均产压 (Py).
评估二甲基酸盐 (DEC),水和甘油作为MCC的增塑剂的有效性.

主要方法:

溶解度参数计算被用来预测MCC-塑化剂的混合性.
装有可塑化剂的MCC球体使用溶剂方法准备,然后蒸发.
描述涉及TGA,DSC,pXRD,FTIR,压力位移配置文件,以及内模Heckel分析以确定Py.

主要成果:

装有可塑化剂的MCC显示可塑性增加,以降低平均产量压力 (Py) 表示.
与非塑化MCC (Py = 136.5 MPa) 相比,甘油 (Py = 99.9 MPa) 和水 (Py = 106.6 MPa) 显著降低了Py.
观察到的可塑性变化与基于可溶性参数的预测混合性相关.

结论:

用精选的增塑剂,特别是糖醇和水加载MCC,有效地增加了其可塑性.
这种塑化显著降低了平均产量压力,提供了一种减轻压缩问题的策略.
该研究展示了一种可行的方法来修改MCC可塑性,以改善制药加工.

关键词:

糖醇糖醇是什么糖醇糖醇是什么平均收益率压力是什么意思微晶纤维素的微晶纤维素.塑化剂塑化剂塑化剂溶解度参数溶解度参数药片药片是一种药片.收益率压力收益率压力是什么

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