Excipients play a central role in the design of a robust product with a sound control strategy that would conform to meaningful specifications during its lifecycle. Excipient selection during formulation design influences business-critical and clinically significant drug product performance outcomes such as stability, bioavailability, and manufacturability. Therefore, thorough understanding of excipient variability is critical to robust drug product development. Importantly, the International Council on Harmonization (ICH) draws attention to excipient understanding in the ICH guideline Q8(R2), emphasizing the need for enhanced knowledge of product performance over a wide range of material attributes.

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