Advances in Orally Disintegrating Tablets (ODTs): Formulation Strategies and Future Prospects

Abstract

Objective: This review critically evaluates recent advances in orally disintegrating tablet (ODT) technologies, with emphasis on innovative formulation and manufacturing strategies developed to overcome the limitations of conventional ODT approaches, particularly for poorly soluble and high-dose drug substances. Data Sources: A comprehensive narrative literature review was conducted using PubMed, Scopus, and ScienceDirect, supplemented by relevant articles identified from Google Scholar, reference lists of selected publications, and other authoritative pharmaceutical sources. Relevant pharmaceutical literature and regulatory guidelines were reviewed, with a primary emphasis on emerging technologies published between 2015 and 2026. Summary Of Contents: While ODTs have significantly improved patient compliance, especially among pediatric and geriatric populations, formulation challenges persist for Biopharmaceutics Classification System (BCS) Class II and IV drugs and high-dose active pharmaceutical ingredients. This review explores emerging technologies such as fused deposition modeling (FDM), selective laser sintering (SLS), and binder jetting 3D printing, which enable enhanced control over tablet architecture, porosity, and disintegration behavior. Additionally, the incorporation of nanotechnology-driven systems, including nanocrystals and spray-dried amorphous solid dispersions, has shown promise in improving drug dissolution and oral bioavailability. Critical quality attributes, including disintegration time, mechanical strength, and moisture sensitivity, are evaluated, with particular attention to formulation performance under tropical climatic conditions (ICH Zone IVb). Prospects emphasize a shift toward point-of-care personalized medicine and the potential for mucoadhesive ODTs in biologics delivery, while identifying current barriers to large-scale commercial adoption and the evolving regulatory landscape for biowaivers. Conclusion: The convergence of advanced manufacturing technologies and rational formulation design positions next-generation ODTs as a promising platform for patient-centric drug delivery, while emphasizing the need for scalable, robust, and climate-resilient manufacturing strategies. Keywords: Orally disintegrating tablets, 3D printing, nanotechnology, bioavailability, patient compliance, BCS classification.