Excipients, once considered as far less important than the active pharmaceutical ingredient (API) in formulated medicines, today are receiving significantly more attention from both manufacturers and regulators. Many excipient technologies are no longer considered as simply inactive ingredients. Their potential to increase efficacy through enhancement of solubility and bioavailability, enable specialized delivery performance (disintegration, controlled/sustained release, etc.) and provide technologies targeting pediatric and geriatric patient populations (taste masking, oral biologic drug delivery) is now recognized. Excipients are today, in fact, seen as crucial to product development and differentiation, particularly for patent extensions and competitive advantage in the generic/biosimilars space, and the possible key to the formulation of many exciting drug candidates that were rejected in the past due to their poor physicochemical and/ or pharmacokinetic properties. There is also greater awareness of the potential of excipients to significantly impact the safety of drug products. Both industry-wide groups and regulators have consequently taken steps to establish processes for ensuring the quality and safety of excipients across the entire excipient supply chain.

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