Development and Evaluation of Multiple-Unit Tablets for the Controlled Release of Lornoxicam.

Abstract

<h4>Background and objective</h4>Lornoxicam (LOX) is a nonsteroidal anti-inflammatory drug used for pain management but requires frequent dosing due to its short half-life. This study aimed to develop a biphasic-release multiple-unit tablet (MUT) to achieve rapid and sustained LOX release with dose flexibility.<h4>Methods</h4>LOX-loaded extended-release (ER) pellets were prepared by fluidized-bed coating of microcrystalline cellulose cores and optimized using a Box-Behnken design. The pellets were coated with Eudragit^® RL/RS and combined with an immediate-release (IR) component to form MUTs by conventional tableting. Pellets and tablets were evaluated for physicochemical properties and in vitro drug release.<h4>Results</h4>Optimized ER pellets showed high drug-loading efficiency (92.2 ± 3%) and good mechanical properties. Drug release from ER pellets was best described by the Korsmeyer-Peppas model, indicating Fickian diffusion. The MUTs exhibited an initial LOX release of approximately 38%, followed by sustained release for 24 h, with > 90% cumulative release. Split tablets demonstrated release profiles comparable to intact tablets (f₂ > 50).<h4>Conclusion</h4>The developed biphasic-release MUTs provide rapid onset, sustained LOX delivery, and reliable dose flexibility, representing a promising oral formulation for LOX therapy.