关口药物产品中的颗粒可见度值的定义 - - 向视觉检查操作员资格标准化迈进
Filip M Fedorowicz1, Andreas Zerr1, Roman Mathaes1
1Clear Solutions Laboratories AG, Mattenstrasse 22, 4058 Basel, Switzerland; and.
PDA journal of pharmaceutical science and technology
|December 27, 2024
概括
可以定义一个单一的大小值可见颗粒在肠道药物可以定义,独立于形状. 这一发现基于人类视觉感知和基于区域的测量,有助于标准化药品检查和提高产品质量.
科学领域:
- 制药科学 制药科学
- 眼科医生 眼科 眼科
- 计量学 计量学 计量学
背景情况:
- 亲肠道药物的视觉检查目前依赖于基于形状和形态的颗粒的可变大小值.
- 现有的指导方针表明粒子可见度值范围广泛,从数百到数千微米.
- 这种变化给制药制造业的一致和可靠的质量控制带来了挑战.
研究的目的:
- 通过实验来确定可见粒子是否存在单一的,形状独立的可检测性尺寸值.
- 研究人类视觉感知和基于面积的尺寸参数在粒子可见性中的作用.
- 探索产品属性对颗粒可见度值的影响.
主要方法:
- 在受控观测条件下实验性确定粒子可见度值.
- 使用基于面积的尺寸参数,特别是等效圆径 (ECD),用于粒子测量.
- 多样化的颗粒形态和产品属性 (如容器,填充量) 来评估它们的影响.
主要成果:
- 证明了可见粒子单一,形状和形态学独立的可检测性尺寸值的存在.
- 证实了等效圆直径 (ECD) 有效地捕捉了不同类型粒子的可见度值.
- 确定产品属性对观察到的可见度值有显著影响.
结论:
- 一个统一的,基于面积的尺寸值 (ECD) 可以标准化对肠道药物的视觉检查.
- 这种方法与人类视觉感知生理学保持一致,提供了更科学的方法.
- 视觉检查实践的标准化将提高制药产品质量和患者安全.
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