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Purpose <p>This study aimed to investigate a novel esomeprazole magnesium (EMP)-loaded bilayer tablet designed for rapid onset and improved bioavailability.</p> Methods <p>An acid-neutralizing agent was selected based on acid neutralizing capacity, buffering capacity and compatibility test. Subsequently, EMP-loaded bilayer tablet manufacturing, dissolution test, and in vivo studies using beagle dogs were conducted.</p> Results <p>Magnesium hydroxide, chosen for its acid-neutralizing and pH-buffering capacities, and was identified as the most suitable agent for enhancing patient compliance (350&#xa0;mg/t). Given EMP’s susceptibility to gastric acid decomposition, a time-dependent release bilayer tablet formulation was developed. Simulated gastric release tests confirmed rapid release and pH profiles, comparing favorably with commercial EMP products. the formulation ensured the acid-neutralizing agent layer disintegrated faster than the drug layer, maintaining stability under accelerated conditions (40℃/75%RH) for 6 months in high-density polyethylene containers. In vivo pharmacokinetic studies demonstrated similar area under the drug concentration- time curve to a comparable commercial EMP product, with a significantly faster absorption rate (time taken to reach the maximum plasma concentration approximately 3.5-fold).</p> Conclusion <p>This novel EMP-loaded bilayer tablet, containing magnesium hydroxide, represents an optimal treatment option for patients requiring immediate therapeutic effects.</p>

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Novel esomeprazole magnesium bilayer tablet with magnesium hydroxide: enhanced onset time and bioavailability in beagle dogs

  • 期刊论文

  • 发表日期：

    2025年1月29日

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  • Taek Kwan Kwon,
  • Jung Hyun Cho,
  • Chun-Woong Park

摘要

Purpose

This study aimed to investigate a novel esomeprazole magnesium (EMP)-loaded bilayer tablet designed for rapid onset and improved bioavailability.

Methods

An acid-neutralizing agent was selected based on acid neutralizing capacity, buffering capacity and compatibility test. Subsequently, EMP-loaded bilayer tablet manufacturing, dissolution test, and in vivo studies using beagle dogs were conducted.

Results

Magnesium hydroxide, chosen for its acid-neutralizing and pH-buffering capacities, and was identified as the most suitable agent for enhancing patient compliance (350 mg/t). Given EMP’s susceptibility to gastric acid decomposition, a time-dependent release bilayer tablet formulation was developed. Simulated gastric release tests confirmed rapid release and pH profiles, comparing favorably with commercial EMP products. the formulation ensured the acid-neutralizing agent layer disintegrated faster than the drug layer, maintaining stability under accelerated conditions (40℃/75%RH) for 6 months in high-density polyethylene containers. In vivo pharmacokinetic studies demonstrated similar area under the drug concentration- time curve to a comparable commercial EMP product, with a significantly faster absorption rate (time taken to reach the maximum plasma concentration approximately 3.5-fold).

Conclusion

This novel EMP-loaded bilayer tablet, containing magnesium hydroxide, represents an optimal treatment option for patients requiring immediate therapeutic effects.