PLGA-based long-acting injectable (LAI) formulations.

Long-acting injectable (LAI) formulations, which deliver drugs over weeks or months, have been in use for more than three decades. Most clinically approved LAI products are formulated using poly(lactide-co-glycolide) (PLGA) polymers. Historically, the development of PLGA-based LAI formulations has relied predominantly on trial-and-error methods, primarily due to a limited understanding of the complex factors involved in LAI formulations and insufficient analytical techniques available for characterizing individual PLGA polymers of the prepared formulations. This article offers a personal perspective on recent advancements in characterization methods for PLGA polymers within final formulations, i.e., products, as well as enhanced insights into the drug release mechanisms associated with LAI products. With a deeper understanding of PLGA polymer properties and drug release mechanisms, the formulation development process can transition from traditional trial-and-error practices to a more systematic Quality by Design (QbD) approach. Additionally, this article explores the emerging role of artificial intelligence (AI) in formulation science and its potential, when applied carefully, to enhance the future development of PLGA-based LAI formulations.