Purpose

The objective of this article is to review the critical material attributes of pharmaceutical excipients employed in solid dosage manufacturing and link them to critical quality attributes (CQAs). Material attributes can have a profound impact on CQAs of product.

Methods

The importance of particle size, particle morphology, density, moisture content, and polymorphism to product CQAs is discussed.

Results

Physical functional attributes of excipients are determined by a complex interaction of the particle size, shape, density, surface area, and particle arrangement in the crystal lattice and consequently, modification of existing excipients focuses primarily on these parameters. These factors govern the process capability of excipients, including ease in powder handling. Therefore, the success or failure of the tableting process will depend on how these parameters interact.

Conclusion

The micromeritic properties of pharmaceutical powders are critical to powder cohesiveness, flow properties and segregation, tablet hardness, disintegration, and dissolution.

中文翻译：

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与固体剂型制造相关的关键赋形剂属性

目的

本文的目的是回顾固体剂型生产中所用药物赋形剂的关键材料属性，并将其与关键质量属性（CQA）关联。材料属性可以对产品的CQA产生深远的影响。

方法

讨论了粒度，颗粒形态，密度，水分含量和多态性对产品CQA的重要性。

结果

赋形剂的物理功能属性取决于颗粒大小，形状，密度，表面积和晶格中颗粒排列的复杂相互作用，因此，现有赋形剂的改性主要集中在这些参数上。这些因素决定了赋形剂的加工能力，包括粉末处理的简便性。因此，压片过程的成功或失败将取决于这些参数如何相互作用。

结论

药物粉末的微团性质对粉末的粘结性，流动性和偏析，片剂硬度，崩解和溶解至关重要。