Emerging Technologies in Granulation: Process Analytical Technologies and Modeling Approaches in Pharmaceutical Development and Manufacturing

Abstract

In the present review, 32 studies, published between 2020 and 2026, were reviewed to identify recent advances in pharmaceutical granulation. Emphasis is placed on the integration of real-time monitoring technologies, recent Process Analytical Technologies (PATs) approaches, the relationships between critical process parameters (CPPs) and critical quality attributes (CQAs) affecting the product, and continuous manufacturing, as well as the implementation of modern data processing models. Increased attention was paid to continuous granulation using twin-screw extrusion, alongside the use of spectroscopic technologies for monitoring the production continuum. Finally, novel modeling approaches are discussed, revealing a transition from solely empirical methods toward hybrid models that combine data analysis tools with mechanistic process understanding and Artificial Intelligence (AI)-driven applications, yielding a new era with the transformation of both batch and continuous manufacturing. The study highlights the integration of PATs, modeling and QbD to enhance process understanding and control, but also challenges from a regulatory framework perspective that resulting from these technological advancements.