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Discrete element modeling and breakage behavior analysis of oral solid dosage form particles
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Lin-xiu LUO1, Tian-bing GUAN1, An-qi LUO1, Zeng LIU1, Yu-ting WANG1, Yan-ling JIANG1, Zheng LU1, Jing-cao TANG1, Shuang-kou CHEN1, Hui-min SUN2, *, Chuan-yun DAI1, *
Acta Pharmaceutica Sinica | 2024, 59(4) : 1057 - 1066
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Acta Pharmaceutica Sinica | 2024, 59(4): 1057-1066
Original Articles
Discrete element modeling and breakage behavior analysis of oral solid dosage form particles
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Lin-xiu LUO1, Tian-bing GUAN1, An-qi LUO1, Zeng LIU1, Yu-ting WANG1, Yan-ling JIANG1, Zheng LU1, Jing-cao TANG1, Shuang-kou CHEN1, Hui-min SUN2, *, Chuan-yun DAI1, *
Affiliations
  • 1. School of and Chemical Engineering, Chongqing University of Science and Technology, Chongqing Key Laboratory of Pharmaceutical Digitalization, Chongqing 401331, China
  • 2. National Institutes for Food and Drug Control, Beijing 100050, China
Published: 2024-04-12 doi: 10.16438/j.0513-4870.2023-0980
Outline
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The breakage pattern of unit particles during the production of oral solid dosage forms (OSD) is closely related to the quality of intermediate or final products. To accurately characterize the particles and study the evolution law of particle breakage, the Bonding model of the discrete element method (DEM) was used to investigate the breakage patterns of model parameters, particle shape and process conditions (loading mode and loading rate) on the dynamic breakage, force-time curve, breakage rate, maximum breakage size ratio and fracture strength of particles. The results showed that the particle breakage force was positively correlated with normal strength and bonded disk scale, negatively correlated with normal stiffness per unit area and tangential stiffness per unit area, and weakly correlated with tangential strength. The particle breakage rate was negatively correlated with the aspect ratio of the particles, and the maximum breakage size ratio was positively correlated with the aspect ratio of the particles; among the three loading modes, the breakage rate of compression breakage model was the largest, the breakage rate of shear breakage model was the second largest, and the breakage rate of wear breakage model was the smallest; the maximum breakage size ratio was positively correlated with the loading rate, the loading mode and the loading rate had no mutual influence on particle breakage rate, but had mutual influence on the maximum breakage size ratio. The research results will provide a theoretical basis for the shift of OSD from batch manufacturing to advanced manufacturing.

particle  /  discrete element modeling  /  bonding model  /  breakage law
Lin-xiu LUO, Tian-bing GUAN, An-qi LUO, Zeng LIU, Yu-ting WANG, Yan-ling JIANG, Zheng LU, Jing-cao TANG, Shuang-kou CHEN, Hui-min SUN, Chuan-yun DAI. Discrete element modeling and breakage behavior analysis of oral solid dosage form particles[J]. Acta Pharmaceutica Sinica, 2024 , 59 (4) : 1057 -1066 . DOI: 10.16438/j.0513-4870.2023-0980
Year 2024 volume 59 Issue 4
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Article Info
doi: 10.16438/j.0513-4870.2023-0980
  • Receive Date:2023-08-16
  • Online Date:2025-11-28
  • Published:2024-04-12
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History
  • Received:2023-08-16
  • Revised:2024-02-28
Funding
Affiliations
    1. School of and Chemical Engineering, Chongqing University of Science and Technology, Chongqing Key Laboratory of Pharmaceutical Digitalization, Chongqing 401331, China
    2. National Institutes for Food and Drug Control, Beijing 100050, China
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表12种不同金属材料的力学参数

Family
属数
Number of
genus
种数
Number of
species
占总种数比例
Percentage of
total species (%)

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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