Orally Disintegrating Tablets: Formulation Science, Mechanistic Insights, and Emerging Innovations in Patient-Centric Drug Delivery

Abstract

Orally disintegrating tablets (ODTs) have redefined oral drug delivery by merging the benefits of conventional solid dosage forms with the convenience and compliance advantages of liquid formulations. Designed to disintegrate rapidly on the tongue without the need for water, ODTs ensure rapid drug release, improved bioavailability, and enhanced patient adherence, particularly among pediatric, geriatric, and dysphagic populations. Over the past two decades, extensive research has focused on optimizing the formulation parameters of ODTs superdisintegrants, diluents, binders, and taste-masking agents to achieve ideal performance characteristics including rapid disintegration, pleasant mouthfeel, and adequate mechanical integrity. Technological advances, such as lyophilization, sublimation, spray drying, molding, and 3D printing, have further expanded the design possibilities of ODTs. Moreover, the integration of nanocrystals, mucoadhesive agents, and machine learning–based formulation prediction has elevated the scientific understanding of ODT performance. This review provides a detailed examination of the principles governing ODT formulation, physicochemical mechanisms of disintegration, advances in manufacturing technologies, evaluation standards, and regulatory frameworks. The article also explores the emerging frontier of 3D-printed and AI-optimized ODTs, offering insights into their clinical relevance, sustainability, and potential to transform patient-centric drug delivery systems in the coming decades.