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Background <p>The current research aimed to formulate and evaluate Metoprolol succinate-containing minitablets. Preliminary batches of sustained-release minitablets were formulated, the factorial design was employed, and quality by design was applied to formulation.</p> Methods <p>A full 3<sup>2</sup> factorial design was applied for preparing minitablets using the direct compression method and varying concentrations of glyceryl behenate and HPMC K100M. Pre- and post-formulation characteristics were assessed. Different formulation parameters were evaluated for both drugs and formulations. A stability study was performed for 6 months, and the optimized batch was compared with the marketed formulation.</p> Results <p>The results exhibited no appreciable interactions between drugs and excipients during the preformulation study. Thus, it can be predicted that there was compatibility between the drug and excipients. Formulation F1, which has 2.5% HPMC K100M and 40% glyceryl behenate and follows zero-order release kinetics, was intended to be the best formulations. The quality of the formulation can be maintained by controlling the critical parameters in accordance with the results.</p> Conclusion <p>The formulated minitablets remained stable for six months, and the results point to Metoprolol minitablets as a potentially useful technology for a controlled-release drug delivery system utilizing glyceryl behenate and HPMC K100M.</p>

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Formulation and Optimization of Sustained Release Minitablets in Capsule System for Metoprolol Succinate: a Quality by Design Approach

  • 期刊论文

  • 发表日期：

    2025年10月24日

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  • Shoaeb Mohammad Syed,
  • Tarannum Rashid Patave,
  • Satyapal Gaikwad,
  • Ajinkya Holkar,
  • Somnath Kalegaonkar,
  • Vinod Mokale,
  • Priyanka Thore,
  • Vandana Shirsath

摘要

Background

The current research aimed to formulate and evaluate Metoprolol succinate-containing minitablets. Preliminary batches of sustained-release minitablets were formulated, the factorial design was employed, and quality by design was applied to formulation.

Methods

A full 32 factorial design was applied for preparing minitablets using the direct compression method and varying concentrations of glyceryl behenate and HPMC K100M. Pre- and post-formulation characteristics were assessed. Different formulation parameters were evaluated for both drugs and formulations. A stability study was performed for 6 months, and the optimized batch was compared with the marketed formulation.

Results

The results exhibited no appreciable interactions between drugs and excipients during the preformulation study. Thus, it can be predicted that there was compatibility between the drug and excipients. Formulation F1, which has 2.5% HPMC K100M and 40% glyceryl behenate and follows zero-order release kinetics, was intended to be the best formulations. The quality of the formulation can be maintained by controlling the critical parameters in accordance with the results.

Conclusion

The formulated minitablets remained stable for six months, and the results point to Metoprolol minitablets as a potentially useful technology for a controlled-release drug delivery system utilizing glyceryl behenate and HPMC K100M.