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Current approaches for in vitro drug release study of long-acting injectable formulations*
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Jing-wen WANG, Qiang WEN, Yu-shuai PENG, Wen ZHAO**, Li-hui YIN**
Chinese Journal of Pharmaceutical Analysis | 2024, 44(11) : 1842 - 1851
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Chinese Journal of Pharmaceutical Analysis | 2024, 44(11): 1842-1851
Review & Monograph
Current approaches for in vitro drug release study of long-acting injectable formulations*
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Jing-wen WANG, Qiang WEN, Yu-shuai PENG, Wen ZHAO**, Li-hui YIN**
Affiliations
  • National Institutes for Food and Drug Control,National Medical Products Administration Key Laboratory for Quality Research and Evaluation of Chemical Drugs,Beijing 102629,China
Published: 2024-12-01 doi: 10.16155/j.0254-1793.2024-0364
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Long-acting injectable formulations are preferred over conventional formulations for the treatment of chronic diseases. The regulatory guidelines and pharmacopoeia have remained silent on dissolution methods for long-acting injectable formulations due to their diverse nature. The lack of compendial method for dissolution testing increases the duration of approval process for long-acting injectable formulations. This article reviews various dissolution methods used to study in vitro drug release profile of long-acting injectable formulations. Compendial as well as noncompendial methods,such as-flow-through cell method,sample and separate method,the dialysis method are used by researchers for drug release profile of long-acting injectable formulations. This review article also highlights the advantages and disadvantages of reported dissolution methods. The compiled work will help the researchers in designing the bio-relevant dissolution method and expedite the development of long-acting injectable formulations.

long-acting injectable formulations  /  dissolution apparatus  /  flow-through cell method  /  sample and separate method  /  dialysis method  /  in vitro models
Jing-wen WANG, Qiang WEN, Yu-shuai PENG, Wen ZHAO, Li-hui YIN. Current approaches for in vitro drug release study of long-acting injectable formulations*[J]. Chinese Journal of Pharmaceutical Analysis, 2024 , 44 (11) : 1842 -1851 . DOI: 10.16155/j.0254-1793.2024-0364
Year 2024 volume 44 Issue 11
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doi: 10.16155/j.0254-1793.2024-0364
  • Receive Date:2024-05-30
  • Online Date:2026-03-18
  • Published:2024-12-01
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  • Received:2024-05-30
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    National Institutes for Food and Drug Control,National Medical Products Administration Key Laboratory for Quality Research and Evaluation of Chemical Drugs,Beijing 102629,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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