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Background and Objective <p>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.</p> Methods <p>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<sup>®</sup> 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.</p> Results <p>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&#xa0;h, with &gt; 90% cumulative release. Split tablets demonstrated release profiles comparable to intact tablets (<i>f</i><sub>2</sub>&#xa0;&gt;&#xa0;50).</p> Conclusion <p>The developed biphasic-release MUTs provide rapid onset, sustained LOX delivery, and reliable dose flexibility, representing a promising oral formulation for LOX therapy.</p>

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

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年3月11日

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  • Yang Liu,
  • Qiong-zhi Shi,
  • Yanchen Wang,
  • Ze-chun Long,
  • Man Han,
  • Yuan Zeng,
  • Xiang-yang Xie,
  • Hui Liu

摘要

Background and Objective

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.

Methods

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.

Results

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).

Conclusion

The developed biphasic-release MUTs provide rapid onset, sustained LOX delivery, and reliable dose flexibility, representing a promising oral formulation for LOX therapy.