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A Systematic Intelligent Optimization Framework for a Sustained-Release Formulation Design.

Yuchao Qiao1,2, Yijia Wu1,2, Mengchen Han1,2

  • 1Department of Health Statistics, School of Public Health, Shanxi Medical University, Taiyuan 030001, China.

Pharmaceutics
|November 27, 2025
PubMed
Summary
This summary is machine-generated.

This study presents an optimized strategy for sustained-release drug formulations using mixture experiments and advanced algorithms. Formulation 45 demonstrated superior drug release profiles, significantly improving upon the original design.

Keywords:
exterior penalty functionintelligent optimization algorithmmulti-criteria decision-makingmulti-objective optimizationsustained-release formulation

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Area of Science:

  • Pharmaceutical Sciences
  • Formulation Development
  • Drug Delivery Systems

Background:

  • Optimizing multi-component sustained-release formulations is complex due to numerous interacting variables.
  • Traditional methods often struggle to account for component interactions and optimize multiple objectives simultaneously.

Purpose of the Study:

  • To develop and validate a systematic strategy for optimizing sustained-release formulations using mixture experiments.
  • To identify optimal formulation compositions that enhance drug release profiles.
  • To integrate advanced statistical and computational methods for robust formulation optimization.

Main Methods:

  • Variable screening using LASSO regression, Smoothly Clipped Absolute Deviation (SCAD), and Minimax Concave Penalty (MCP).
  • Construction of a quadratic inference function-based objective model.
  • Multi-objective optimization using NSGA-III, MOGWO, and NSWOA algorithms to generate Pareto-optimal solutions.
  • Evaluation of solutions using the entropy weight method and TOPSIS for reduced bias.

Main Results:

  • The MCP-screened model showed excellent fit (AIC=19.8028, BIC=45.2951), confirming its suitability for optimization.
  • Formulation 45, containing specific ratios of HPMC K4M, HPMC K100LV, MgO, lactose, and anhydrous CaHPO4, exhibited superior sustained release.
  • Cumulative drug release rates for Formulation 45 were 22.75% (2h), 64.98% (8h), and 100.23% (24h), significantly improved over the original.

Conclusions:

  • The integrated workflow effectively models component interactions and repeated measurements for sustained-release formulations.
  • This approach provides a robust, scientifically grounded method for optimizing complex, multi-component drug delivery systems.
  • The optimized formulation demonstrates enhanced drug release characteristics, offering potential clinical benefits.