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首页> 外文期刊>Journal of pharmaceutical sciences. >Real-Time assessment of granule and tablet properties using in-line data from a high-shear granulation process.
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Real-Time assessment of granule and tablet properties using in-line data from a high-shear granulation process.

机译：使用来自高剪切造粒过程的在线数据实时评估颗粒和片剂的性能。

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摘要

A method for real-time assessment of granule and tablet properties was investigated. A mixture of microcrystalline cellulose:mannitol:povidone (78.5:18.5:3) was used in the study and granulated with five different water amounts and two impeller speeds. This represents a full-factorial design with two factors, thus giving a causal structure to the variation between the experiments. Process data (power consumption, temperature and in-line near-infrared spectra) were collected during the granulations. In addition to the in-line process data, critical granule and tablet quality properties (such as particle size, porosity and tablet hardness) were measured in order to achieve in-depth process understanding. Neither power consumption nor temperature gave information that could be directly attributable to tablet properties, and these techniques were also heavily dependent on the speed of the impeller. In contrast, when using the first NIR overtone band for water (1460 nm), in-line real-time assessment of dry granule and tablet properties could be achieved.
机译：研究了一种实时评估颗粒和片剂性质的方法。在研究中使用了微晶纤维素：甘露醇：聚维酮的混合物（78.5：18.5：3），并用五种不同的水量和两种叶轮速度将其制粒。这代表了具有两个因素的全要素设计，因此为实验之间的变化提供了因果结构。制粒过程中收集了过程数据（功耗，温度和在线近红外光谱）。除了在线过程数据之外，还对关键的颗粒和片剂质量特性（例如粒度，孔隙率和片剂硬度）进行了测量，以实现对过程的深入了解。功耗和温度都无法提供可直接归因于平板电脑特性的信息，并且这些技术还很大程度上取决于叶轮的速度。相反，当将第一个NIR泛音带用于水（1460 nm）时，可以在线实时评估干燥颗粒和片剂的性能。

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