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Background <p>Poor aqueous solubility remains a major barrier to dissolution, bioavailability, and therapeutic efficacy. Amorphous solid dispersions (ASDs) are a promising formulation strategy to enhance solubility and dissolution by inducing supersaturation. However, the conventional quality-by-testing (QbT) paradigm often yields inconsistent quality, higher cost, and longer timelines. The quality-by-design (QbD) framework provides a systematic path to develop robust, scalable ASDs while reducing development time and cost.</p> Area covered <p>This review examines the application of QbD principles to ASD product development, outlines key QbD elements, and summarizes relevant quality assessment methods and prior research. We also discuss tableting considerations for QbD-prepared ASDs and highlight pharmacokinetic outcomes to inform strategies for successful clinical translation.</p> Expert opinion <p>Future work should close the gap between preclinical pharmacokinetic performance and clinical outcomes while addressing scalability, food effects, inter-individual variability, and long-term safety. Extending the QbD framework beyond manufacturing to dosage-form development will facilitate clinical translation of ASD products.</p>

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Modern approaches to quality by design for amorphous solid dispersion product development: a narrative review

  • 期刊论文

  • 发表日期：

    2026年1月19日

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  • Jain Koo,
  • Hyewon Jeon,
  • Jaehyun Cheong,
  • Yuyoung Joo,
  • Seohyeon Han,
  • Hyunjin Kim,
  • Jimin Oh,
  • Deokkyu Lee,
  • Kyung Taek Oh

摘要

Background

Poor aqueous solubility remains a major barrier to dissolution, bioavailability, and therapeutic efficacy. Amorphous solid dispersions (ASDs) are a promising formulation strategy to enhance solubility and dissolution by inducing supersaturation. However, the conventional quality-by-testing (QbT) paradigm often yields inconsistent quality, higher cost, and longer timelines. The quality-by-design (QbD) framework provides a systematic path to develop robust, scalable ASDs while reducing development time and cost.

Area covered

This review examines the application of QbD principles to ASD product development, outlines key QbD elements, and summarizes relevant quality assessment methods and prior research. We also discuss tableting considerations for QbD-prepared ASDs and highlight pharmacokinetic outcomes to inform strategies for successful clinical translation.

Expert opinion

Future work should close the gap between preclinical pharmacokinetic performance and clinical outcomes while addressing scalability, food effects, inter-individual variability, and long-term safety. Extending the QbD framework beyond manufacturing to dosage-form development will facilitate clinical translation of ASD products.