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在压缩口服固体剂型中非破坏性检测分解剂水平
Tipu Sultan1, Enamul Hasan Rozin1, Vivek S Dave2
1Photo-Acoustics Research Laboratory, Department of Mechanical and Aerospace Engineering, Clarkson University, Potsdam, NY 13699-5725, USA.
International journal of pharmaceutics
|June 25, 2023
概括
超声波可以通过将波速和衰减与分解水平和压缩力相关联,快速评估平板电脑的质量. 这种非破坏性方法有助于制药制造和实时释放测试.
科学领域:
- 制药科学 制药科学
- 材料科学 材料科学 材料科学
- 声学 声学 在声学上
背景情况:
- 压缩口服固体剂量 (OSD) 的质量,特别是分解和药物释放,对于立即释放产品至关重要.
- 在粒级的微纹理和粘弹性特性显著影响OSD性能.
- 配方成分,包括分解水平和矩阵孔隙性,影响这些关键性质.
研究的目的:
- 提出和验证一种新的,快速的,非破坏性的OSD超声波表征技术.
- 为了将超声波特性与分解水平和压缩力相关联.
- 探索超声波在制药制造中的质量控制方面的潜力.
主要方法:
- 通过OSD传输纵向和剪切超声波.
- 计算波速以确定明显的和剪模.
- 分散分析以获得波衰减概况和研究波传播.
主要成果:
- 超声波速度,物理/机械性能和衰减配置文件显示出对不同解体水平 (七级) 和压缩力 (五级) 的敏感性.
- 该研究确定了超声波参数与关键的药片配方和加工变量之间的相关性.
- 证明了超声波技术的潜力,以非破坏性地探测OSD微观结构特征.
结论:
- 超声波表征为OSD质量评估提供了一种可行,快速,非破坏性和具有成本效益的方法.
- 该技术支持制药生产中的连续制造 (CM) 和实时释放测试 (RTRT).
- 该研究强调了超声波在确保OSD产品质量和性能方面的实用实用性.
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