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The Quantification of Injectability by Mechanical Testing
Published on: May 13, 2020
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冲击测试作为一种新的方法来确定药品片的机械强度
Farhan Alhusban1, Euan F Murgatroyd1
1Pharmaceutical Technology and Development, AstraZeneca, Macclesfield SK10 2NA, UK.
International journal of pharmaceutics
|February 12, 2024
概括
冲击断裂力测试提供了比标准断裂力测试更好的药物片质量控制. 这种新方法准确地预测了平板电脑的缺陷率,减少了浪费和制造成本.
科学领域:
- 制药科学 制药科学
- 材料科学 材料科学 材料科学
- 机械工程 机械工程
背景情况:
- 标准的平板电脑破裂力测试与制造和分销过程中遇到的现实世界机械应力没有相关性.
- 目前的方法无法考虑冲击能量传递,导致无法预测平板电脑缺陷率.
研究的目的:
- 开发和验证用于药品片的冲击断裂力测试.
- 与传统方法相比,评估撞击骨折力与平板电脑缺陷率的相关性.
- 为强大的制药产品开发引入仪器冲击测试仪.
主要方法:
- 修改并开发了一种针对药品片的冲击骨折力测试方法.
- 评估了各种各样的药片配方,其成分,大小,形状和强度各不相同.
- 将撞击骨折力结果与标准平板破碎和易碎性测试进行比较.
主要成果:
- 与破裂力和易碎性测试相比,撞击破裂力与平板电脑缺陷率的相关性更强.
- 开发的方法在各种类型的药片中显示出良好的重复性.
- 仪器冲击断裂力测试仪成功地描述了平板电脑的机械强度.
结论:
- 冲击断裂力测试是药品片质量和缺陷率的更可靠预测指标.
- 这种新的测试方法可以通过设计提高质量,从而产生更强大的产品.
- 实施撞击断裂力测试有潜力显著降低制造成本和材料浪费.
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