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Discussion on the Pharmaceutical Studies in the Development of Ondansetron Oral Soluble Film Generic Drug
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Xiaohong XU1, Shuhua WANG1, Fei LI1, Ming TAO2, Jie TIAN1, *
Chinese Pharmaceutical Journal | 2025, 60(5) : 547 - 552
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Chinese Pharmaceutical Journal | 2025, 60(5): 547-552
Discussion on the Pharmaceutical Studies in the Development of Ondansetron Oral Soluble Film Generic Drug
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Xiaohong XU1, Shuhua WANG1, Fei LI1, Ming TAO2, Jie TIAN1, *
Affiliations
  • 1 Center for Drug Evaluation, NMPA, Beijing 100022, China
  • 2 Shenyang Pharmaceutical University, Benxi 117004, China
Published: 2025-03-08 doi: 10.11669/cpj.2025.05.013
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OBJECTIVE To discuss the problems needing attention in the pharmaceutical research of oral soluble film generic drugs, and to provide reference for the research and development of oral soluble film generic drugs. METHODS By searching the relevant foreign review reports and literature, this paper comparatively analyzed the prescription technology of ondansetron oral soluble film listed in different regions, and combined with the relevant guiding principles, discussed the general considerations in the development of oral soluble film. RESULTS The main research contents of ondansetron oral soluble film were determined around the concerns of prescription technology, quality control and stability. CONCLUSION In the development of oral soluble film generic drugs, clinical drug demand should be taken into consideration,combined with the characteristics of raw and auxiliary materials, prescription composition and production process,reasonable inspection items should be rationally established,and conducting in-depth pharmaceutical research to improve the quality of oral soluble film generic drugs.

ondansetron  /  oral soluble film  /  preparation process  /  quality control  /  pharmaceutical research
Xiaohong XU, Shuhua WANG, Fei LI, Ming TAO, Jie TIAN. Discussion on the Pharmaceutical Studies in the Development of Ondansetron Oral Soluble Film Generic Drug[J]. Chinese Pharmaceutical Journal, 2025 , 60 (5) : 547 -552 . DOI: 10.11669/cpj.2025.05.013
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Year 2025 volume 60 Issue 5
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doi: 10.11669/cpj.2025.05.013
  • Receive Date：2024-07-05
  • Online Date：2025-11-07
  • Published：2025-03-08
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  • Received：2024-07-05
Affiliations
    1 Center for Drug Evaluation, NMPA, Beijing 100022, China
    2 Shenyang Pharmaceutical University, Benxi 117004, China
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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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