The development of orally inhaled and nasal drug products (OINDPs) presents significant challenges, with failure rates of 70% and higher. This high failure rate stems from the complex interplay between formulation, device performance, and patient usage, compounded by limited in vitro – in vivo correlation. Since in vivo testing occurs later in development, integrating real world conditions early, specifically through human-realistic actuation, can enhance regulatory approval chances and commercial success.

Regulatory agencies like the U.S. Food and Drug Administration (FDA) emphasise the importance of selecting actuation settings that reflect real-world patient use, stating that “selection of appropriate settings would be relevant to proper usage of the product by the trained patient.” Variability in actuation behaviour significantly impacts Critical Quality Attribute (CQA) testing, potentially leading to unexpected outcomes and regulatory delays. Conducting human actuation studies and establishing optimised actuation parameters for automated systems minimises variability, strengthens testing methodologies, and mitigates the risk of failure.

Proveris Scientific addresses these challenges through advanced methodologies, such as Proveris Laboratories’ Ergo™ device for Human Actuation Studies and Proveris Scientific’s Vereo® Automated Actuators for automated actuation. Capturing and implementing human-realistic parameters across required tests enhances reproducibility, reduces variability, and accelerates product approval.