Understanding critical material properties for solid dosage form design

What is the role of standardized methods for determining the impact of material properties in pharmaceutical formulation and process development? In this Perspective article, we identify material properties that are potentially important in solid dosage form design, and we review approaches linking these properties to product specifications in dry granulation process development. We also assess the potential benefits that could be obtained by standardizing the methods for determining the impact of material properties of commonly used excipients and propose a program of research to achieve the desired goal of an efficient, science-based approach for incorporating material properties in solid dosage form design.

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