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Visual feature extraction combining dissolution testing for the study of drug release behavior of gliclazide modified release tablets
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Si-yu CHEN1, Ze-ya LI1, Ping LI2, Xin-qing ZHAO2, Tao GONG1, Li DENG1, *, Zhi-rong ZHANG1
Acta Pharmaceutica Sinica | 2025, 60(1) : 225 - 231
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Acta Pharmaceutica Sinica | 2025, 60(1): 225-231
• Original Articles •
Visual feature extraction combining dissolution testing for the study of drug release behavior of gliclazide modified release tablets
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Si-yu CHEN1, Ze-ya LI1, Ping LI2, Xin-qing ZHAO2, Tao GONG1, Li DENG1, *, Zhi-rong ZHANG1
Affiliations
  • 1. Key Laboratory of Drug-Targeting and Drug Delivery System of the Education Ministry and Sichuan Province, West China School of Pharmacy, Sichuan University, Chengdu 610041, China
  • 2. Sichuan Medical Products Administration Key Laboratory for Quality Research and Control of Chemical Medicine, Chengdu Institute for Drug Control, Chengdu 610046, China
Published: 2025-01-12 doi: 10.16438/j.0513-4870.2024-0660
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Oral solid dosage forms require processes such as disintegration and dissolution to release the drug before it can be absorbed and utilized by the body. In this manuscript, imaging technology was used to continuously visualize and characterize the in vitro static drug release process of gliclazide modified release tablets from 15 manufacturers, combined with the traditional method of in vitro dissolution testing, to determine the release profile of gliclazide modified release tablets, to evaluate the similarity of the release profiles by using the similarity factor (f2) method and based on the analysis of the release profiles fitted with a variety of mathematical models. The results indicate that the gliclazide modified release tablets produced by 14 companies are hydrophilic gel matrix tablets. Compared to the reference listed drug, the release profiles of formulations from 11 companies show high similarity (f2 > 50) to the reference. Among these, formulations with visual characteristics similar to the reference exhibit similar release curves. This study provides an alternative method for the in vitro consistency evaluation of gliclazide modified release tablets, aiming to assess the in vitro release behaviour of generic formulations more accurately and comprehensively.

gliclazide modified release tablet  /  hydrogel matrix tablet  /  visualization  /  in vitro dissolution  /  fitted mathematical model
Si-yu CHEN, Ze-ya LI, Ping LI, Xin-qing ZHAO, Tao GONG, Li DENG, Zhi-rong ZHANG. Visual feature extraction combining dissolution testing for the study of drug release behavior of gliclazide modified release tablets[J]. Acta Pharmaceutica Sinica, 2025 , 60 (1) : 225 -231 . DOI: 10.16438/j.0513-4870.2024-0660
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Article Info
doi: 10.16438/j.0513-4870.2024-0660
  • Receive Date：2024-07-15
  • Online Date：2025-11-07
  • Published：2025-01-12
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History
  • Received：2024-07-15
  • Revised：2024-09-03
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Affiliations
    1. Key Laboratory of Drug-Targeting and Drug Delivery System of the Education Ministry and Sichuan Province, West China School of Pharmacy, Sichuan University, Chengdu 610041, China
    2. Sichuan Medical Products Administration Key Laboratory for Quality Research and Control of Chemical Medicine, Chengdu Institute for Drug Control, Chengdu 610046, China
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表12种不同金属材料的力学参数
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Number of
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Number of
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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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