用实验和有限元素方法评估用于在双层平板制剂中紧缩过程中追踪内部裂纹的喷射压力,使用实验和有限元素方法
Sun Ho Kim1, Su Hyeon Han2, Jong-Seok Oh3
1College of Pharmacy, Dankook University, 119, Dandae-ro, Dongnam-gu, Cheonan-si 31116, Republic of Korea.
Pharmaceuticals (Basel, Switzerland)
|March 28, 2024
概括
喷射压力测量可以预测双层片 (BLT) 中的内部裂. 这种方法可以通过在制造前识别问题来防止平板电脑的缺陷,确保平板电脑的完整性.
科学领域:
- 制药技术 制药技术 制药技术
- 材料科学 材料科学 材料科学
- 计算建模 计算建模
背景情况:
- 双叶片 (BLT) 是复杂的剂型,需要仔细的制造控制.
- 内部缺陷,如裂,可能会损害平板电脑的完整性和性能.
- 了解压缩力和平板电脑故障之间的关系至关重要.
研究的目的:
- 为了评估喷射压力作为内裂的指标在甲胺HCl (MF) 和埃沃格利平酸 (EG) BLTs.
- 为了将弹射压力与制造过程中的药片结构变化相关联.
- 用有限元法 (FEM) 模拟来阐明平板电脑失效的机制.
主要方法:
- 用不同的MAIN-P (主要压缩力) 压缩BLT.
- 测量喷射压力和片径差异的测量.
- 对压缩断裂力和孔隙性的分析.
- 用有限元法 (FEM) 模拟应力分布和裂传播分析.
主要成果:
- 喷射压力和直径差异与MAIN-P增加,然后在350-375MPa之间急剧下降.
- 在MAIN-P和破裂力或孔隙性之间没有明显的相关性.
- FEM模拟证实了由于被困空气和局部剪切应力导致分层的裂纹形成.
- 削弱BLT接口的机械完整性与内部裂和降低喷射压力有关.
结论:
- 喷射压力作为一个可靠的,非破坏性的指标,用于预测BLT的内部裂.
- 在FEM模拟中,有效地证明了在平板电脑压缩和弹射过程中内部裂纹和分层的机制.
- 在BLT制造中实施弹射压力监测可以防止看不见的缺陷并确保产品质量.
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