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首页> 外文期刊>American pharmaceutical review >Near-Infra red (NIR) Determination of Uniformity for a Drug Product Powder for Oral Suspension (POS) in Amber Glass Bottles
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Near-Infra red (NIR) Determination of Uniformity for a Drug Product Powder for Oral Suspension (POS) in Amber Glass Bottles

机译：琥珀色玻璃瓶中用于口服混悬液（POS）的药品粉末的近红外（NIR）均匀度测定

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摘要

Near infrared spectroscopy (NIRS) is a rapid analytical technique that is capable of assessing uniformity of a blend in a non-destructive, non-invasive manner [1,2]. These attributes of NIRS make it an effective tool for on-line, at-line or off-line analysis of pharmaceutical products. During the manufacture of a powder for oral suspension (POS), obtaining blend uniformity can present challenges due to factors such as particle size, material cohesiveness and flow ability [3,4]. Segregation may occur during the mixing and filling process which could impact the final quality of the product. The scope of this work was to develop and apply a semi-quantitative method that is capable of trending blend uniformity within a manufacture to troubleshoot the mixing and filling operations during scale-up manufacturing runs.
机译：近红外光谱（NIRS）是一种快速分析技术，能够以非破坏性，非侵入性的方式评估混合物的均匀性[1,2]。 NIRS的这些属性使其成为用于药品在线，离线或离线分析的有效工具。在制造口服混悬剂（POS）的粉末时，由于诸如粒径，材料内聚性和流动性等因素，获得混合均匀性可能会带来挑战[3,4]。在混合和填充过程中可能会发生偏析，这可能会影响产品的最终质量。这项工作的范围是开发和应用一种半定量方法，该方法能够使制造过程中的混合均匀性趋于稳定，以解决按比例放大制造过程中的混合和填充操作。

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