Biologic excipients: Importance of clinical awareness of inactive ingredients.

ABSTRACT: Due to the complexity and fragility of biological drug products, several challenges exist in their formulation development. Excipients are added to increase product stability, maintain tonicity, and facilitate drug delivery. The potential implications of these additive substances merit clinical consideration. We assessed the safety risk of excipients on the basis of their type and variability through an assessment framework, which quantifies excipient complexity in 230 biological formulations, and identifies excipient-related adverse events through published case reports. A biologic on average contained 4.45 excipients, half of that found in oral medications. The frequency distribution was heavily skewed towards the most commonly occurring excipients: water (40.4%), sodium chloride (38.3%)

SUBMITTER: Ionova Y 

PROVIDER: S-EPMC7316246 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature