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Critical Excipient Attributes Relevant to Solid Dosage Formulation Manufacturing

  • Naseem Ahmad CharooEmail author
Review Article
  • 30 Downloads

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.

Keywords

Critical material attributes Functional attributes Critical quality attributes Powder characterization Segregation Compactability Flow properties 

Notes

Compliance with Ethical Standards

Conflict of Interest

The author declares that he has no conflict of interest.

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Copyright information

© Springer Science+Business Media, LLC, part of Springer Nature 2019

Authors and Affiliations

  1. 1.Zeino Pharma FZ LLCDubaiUnited Arab Emirates

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