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Critical Excipient Attributes Relevant to Solid Dosage Formulation Manufacturing

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Abstract

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.

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    Naseem Ahmad Charoo

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Charoo, N.A. Critical Excipient Attributes Relevant to Solid Dosage Formulation Manufacturing. J Pharm Innov 15, 163–181 (2020). https://doi.org/10.1007/s12247-019-09372-w

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