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阿菲尼索尔HPMC的热降解:热挤出和3D打印的最佳加工温度

Roman Svoboda¹, Marie Nevyhoštěná², Jana Macháčková²

¹Department of Physical Chemistry, Faculty of Chemical Technology, University of Pardubice, Studentská 573, 532 10, Pardubice, Czech Republic. roman.svoboda@upce.cz.

Pharmaceutical research

|August 23, 2023

概括

由于氧化,阿菲尼索尔HPMC HME在170°C以上的挤出温度下在空气中显著降解. 安全的热挤出需要在此温度以下进行加工,对于3D打印制药产品可能需要塑化剂.

科学领域:

制药科学制药科学
材料科学材料科学材料科学
聚合物化学聚合物化学

背景情况:

阿菲尼索尔HPMC HME是一种用于制药热挤出和3D打印的高烯酸衍生物.
现有的热稳定性数据仅限于惰性大气层,不反映现实世界的加工条件.

研究的目的:

为了研究阿菲尼索尔HPMC HME 15LV在空气中的热稳定性.
在高温制药加工过程中识别风险和限制.

主要方法:

热重力测量 (TGA) 是一种测量方法.
不同扫描热量计 (DSC)
红外光谱学 (IR) 红外光谱学
粉末和挤出细丝的分析.

主要成果:

在空气中分解发生在三个阶段:在150°C时~5%,在200°C时~70%,在380°C时~15%.
空气中氧化诱导的降解与惰性大气分解有很大的不同.
氧气扩散是热降解中的速度限制步骤.

结论:

阿菲尼索尔HPMC HME在5分钟内在挤出温度≥170°C时显著降解.
纯阿菲尼索尔的热挤出在170°C以下是可行的.
对于安全的3D打印应用,可能需要塑化剂.

关键词:

美国国家安全委员会 DSC.在TGA上,TGA就是TGA.这种药物是Affinisol.热挤出热挤出热降解降解的热性降解

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