Orally disintegrating dosage forms: An overview of formulation insights and case studies

Abstract

Orally disintegrating dosage forms (ODTs and ODFs) are an innovative solution for addressing challenges in drug administration, particularly for patients who have difficulty swallowing, such as pediatric, geriatric, and dysphagic populations. These formulations disintegrate quickly in the oral cavity without the need for water, making them a convenient alternative to traditional solid oral dosage forms. They improve patient compliance and offer a faster onset of action by allowing pre-gastric absorption. This review delves into the formulation strategies behind ODTs and ODFs, focusing on the role of key excipients such as superdisintegrants, taste-masking agents, and film-forming polymers. These components are essential in achieving rapid disintegration, enhancing palatability, and ensuring patient adherence. The article further discusses various manufacturing techniques, including direct compression, freeze-drying, and hot-melt extrusion, highlighting their advantages and limitations. Additionally, novel approaches like 3D printing and multi-channel tablet designs, which promise to enhance drug loading and disintegration efficiency, are explored. Despite their growing popularity, orally disintegrating dosage forms still face several challenges. Persistent hurdles are ensuring sufficient mechanical strength while maintaining fast disintegration, optimizing drug loading, and overcoming taste-masking issues. Moreover, advancements in packaging are needed to protect these fragile formulations and maintain their integrity during handling and storage.