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Research advances in key technologies and real-time quality control for quality by design-driven micrometer-scale tablet formulations
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Lei WU1, Peng-fei REN1, Zhou-bo YU1, Zhen-bo LI1, Yu-xin HE1, Yi-han LIU1, Jing YANG2, Rui WANG1, *
Chinese Journal of New Drugs | 2026, 35(7) : 701 - 709
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Chinese Journal of New Drugs | 2026, 35(7): 701-709
Research advances in key technologies and real-time quality control for quality by design-driven micrometer-scale tablet formulations
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Lei WU1, Peng-fei REN1, Zhou-bo YU1, Zhen-bo LI1, Yu-xin HE1, Yi-han LIU1, Jing YANG2, Rui WANG1, *
Affiliations
  • 1College of Pharmacy of Heilongjiang University of Traditional Chinese Medicine, Harbin 150040, China
  • 2Basic Medical College of Heilongjiang University of Traditional Chinese Medicine, Harbin 150040, China
Published: 2026-04-15 doi: 10.20251/j.cnki.1003-3734.2026.07.005
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Micron-scale tablets (1 000~3 000 μm), driven by the dual forces of Pharmaceutical Industry 4.0 and precision medicine, have emerged as a core carrier for pediatric and personalized treatment due to their exceptional dose flexibility and multi-unit delivery advantages. The quality by design (QbD) concept provides a systematic framework to overcome key industrialization bottlenecks-such as poor flowability at high drug loads, challenges in achieving blend uniformity for ultra-low-dose formulations, and stringent sensitivity requirements for miniaturized quality control-facilitating the successful establishment of a multidimensional "structure-process-quality" correlation model in the field. Research advances demonstrate that the integration of multimodal spectral imaging (HSI-FT-NIR coupling) with neural network fusion technology enables real-time tracking of content uniformity and release profiles at the millimeter level, facilitating the formation of a full-chain quality control closed-loop from process analysis to dynamic release. The integrated application of innovative technologies such as hot melt extrusion-based microfluidic 3D printing offers new pathways for constructing complex functional dosage forms like colon-targeted and gastric-floating tablets. This review further examines the challenges and breakthrough directions for intelligent upgrades in continuous manufacturing under the QbD framework and outlines interdisciplinary pathways and future prospects for the efficient clinical translation of micron-scale tablet technologies.

micron-sized tablets  /  quality by design  /  continuous manufacturing  /  real-time quality control  /  In vitro and in vivo correlations  /  process analytical technology  /  pediatric precision drug delivery  /  3D printing technology
吴磊, 任鹏飞, 于洲波, 李振博, 贺雨欣, 刘祎晗, 杨婧, 王锐. 质量源于设计驱动的微米级片制剂关键技术及实时质量控制研究进展. 中国新药杂志, 2026 , 35 (7) : 701 -709 . DOI: 10.20251/j.cnki.1003-3734.2026.07.005
Lei WU, Peng-fei REN, Zhou-bo YU, Zhen-bo LI, Yu-xin HE, Yi-han LIU, Jing YANG, Rui WANG. Research advances in key technologies and real-time quality control for quality by design-driven micrometer-scale tablet formulations[J]. Chinese Journal of New Drugs, 2026 , 35 (7) : 701 -709 . DOI: 10.20251/j.cnki.1003-3734.2026.07.005
Year 2026 volume 35 Issue 7
33
5
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doi: 10.20251/j.cnki.1003-3734.2026.07.005
  • Online Date:2026-10-26
  • Published:2026-04-15
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  • Accepted:2025-08-13
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    1College of Pharmacy of Heilongjiang University of Traditional Chinese Medicine, Harbin 150040, China
    2Basic Medical College of Heilongjiang University of Traditional Chinese Medicine, Harbin 150040, China
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表12种不同金属材料的力学参数
科
Family
属数
Number of
genus
种数
Number of
species
占总种数比例
Percentage of
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属
Genus
种数
Number of
species
占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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