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<p>Co-amorphous solid dispersions (COAMs) represent a commanding and relatively recent strategy to improve the solubility and bioavailability of poorly soluble active pharmaceutical ingredients. This review focuses on modelling and optimization of COAMs based on components’ descriptors and outputs of advanced characterization techniques, explores new applications in drug development, and offers insights into facilitated regulatory processes. Theories behind the formation of COAMs, including Hansen solubility, Hildebrand solubility, and Flory-Huggins parameters, are discussed, highlighting the prerequisite structural attributes of candidate drugs and coformers required for successful composites. Recent in-silico techniques for modelling and predicting possible COAM formation, involving descriptors such as glass transition temperature, molar mass ratio, enthalpy of mixing, and enthalpy of H-bonding, are investigated. Real-time analysis of API-API and API-coformer mixtures using advanced process analytical technologies will enable early predictions of compatibility and solid-state characterization of COAMs. Prospects for COAMs include addressing new multiple-drug combinations, pre-designed drug-coformers, and drug-drug-coformer ternary systems for treating complex medical conditions. Successfully optimized co-amorphous dispersions would positively impact regulatory processes by providing a basis for designation as co-processed APIs or API-premixes, which could accelerate generic production.</p>

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Co-amorphous Solid Dispersions: Review of Underlying Theories, Recent Development and Prospective Regulatory Requirements

  • 期刊论文

  • 发表日期：

    2026年6月18日

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  • Abdulaziz Yasser Al Osaimi,
  • Zeyad Khalid Aljuhani,
  • Mansour Abdulrahman Mansour,
  • Amjad Hashim Alsaab,
  • Mamdouh Musaed Altalhi,
  • Mohammed H. Elkomy,
  • Rawan Hussain Aloufi,
  • Majed M. Alrobaian,
  • Ahmed M. Abdelhaleem Ali

摘要

Co-amorphous solid dispersions (COAMs) represent a commanding and relatively recent strategy to improve the solubility and bioavailability of poorly soluble active pharmaceutical ingredients. This review focuses on modelling and optimization of COAMs based on components’ descriptors and outputs of advanced characterization techniques, explores new applications in drug development, and offers insights into facilitated regulatory processes. Theories behind the formation of COAMs, including Hansen solubility, Hildebrand solubility, and Flory-Huggins parameters, are discussed, highlighting the prerequisite structural attributes of candidate drugs and coformers required for successful composites. Recent in-silico techniques for modelling and predicting possible COAM formation, involving descriptors such as glass transition temperature, molar mass ratio, enthalpy of mixing, and enthalpy of H-bonding, are investigated. Real-time analysis of API-API and API-coformer mixtures using advanced process analytical technologies will enable early predictions of compatibility and solid-state characterization of COAMs. Prospects for COAMs include addressing new multiple-drug combinations, pre-designed drug-coformers, and drug-drug-coformer ternary systems for treating complex medical conditions. Successfully optimized co-amorphous dispersions would positively impact regulatory processes by providing a basis for designation as co-processed APIs or API-premixes, which could accelerate generic production.