Emerging Trends in Lyophilised Oral Disintegration Tablets: A Formulation Perspective

Ahad Rashad Mohammed Ahmed, S Rajarajan, Beny Baby, Tejas R and K.Ramesh.

Lyophilised oral disintegration tablets (ODTs) have emerged as a cornerstone of patient-centric drug delivery, specifically engineered to dissolve rapidly within the oral cavity without the aid of water. This review provides a comprehensive analysis of modern freeze-dried ODT architectures from a structural formulation perspective. Traditional solid dosage forms often introduce strict therapeutic limitations for pediatric, geriatric, and non-compliant psychiatric patient cohorts suffering from dysphagia. By transitioning active pharmaceutical ingredients (APIs) into highly porous amorphous matrices, lyophilisation effectively bypasses these mechanical constraints. The manufacturing sequence is governed by precise thermodynamic parameters, where controlled freezing, thermal annealing, and primary sublimation dictate the capillary diameter and pore volume fraction of the resulting cake.This article evaluates the strategic selection of water-soluble polymer binders, such as gelatin and polyvinylpyrrolidone, alongside saccharide bulking agents like D-mannitol to optimize matrix rigidity while preventing structural collapse. Particular emphasis is placed on targeted clinical applications, featuring model drugs including Zolmitriptan, Ondansetron, Donepezil hydrochloride, and Olanzapine. Furthermore, advanced taste-masking strategies—such as cyclodextrin inclusion complexation, polymeric microencapsulation, and ion-exchange resin adsorption—are systematically cross-examined regarding their impact on salivary erosion dynamics. Critical quality attributes (CQAs) are established using alternative testing configurations, including texture analysis, modified wetting tests, and X-ray micro-computed tomography. Finally, this review highlights the integration of emerging production paradigms, such as binder-jet 3D printing and artificial intelligence-driven cycle optimization, which are positioned to expand the clinical scope of fast-melting wafers toward personalized biological macromolecule delivery.

Keywords – Lyophilised oral disintegration tablets; Freeze-drying kinetics; Matrix porosity; Taste-masking complexation; Patient-centric drug delivery; Critical quality attributes (CQAs).