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Comparative study on the methods to determine disintegration time of oral soluble films
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Di GAO1, Guo-xiang LI1, Shu-ye QI2, Xue-ping WU3, Chao-qiang XIAO1, 3, Shu-wang HE1, 3, Jie YANG1, 3, *, Wei-feng ZHANG1, 3, *
Acta Pharmaceutica Sinica | 2023, 58(11) : 3204 - 3209
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Acta Pharmaceutica Sinica | 2023, 58(11): 3204-3209
• Special Reports: Pharmaceutical Taste-Masking and Assessment Technologies •
Comparative study on the methods to determine disintegration time of oral soluble films
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Di GAO1, Guo-xiang LI1, Shu-ye QI2, Xue-ping WU3, Chao-qiang XIAO1, 3, Shu-wang HE1, 3, Jie YANG1, 3, *, Wei-feng ZHANG1, 3, *
Affiliations
  • 1. Beijing DYNE High-tech Pediatric Pharmaceutical R&D Institute Co., Ltd., Beijing 100176, China
  • 2. National Institutes for Food and Drug Control, Beijing 102629, China
  • 3. Shandong DYNE Marine Biopharmaceutical Co., Ltd., Weihai 264300, China
Published: 2023-11-12 doi: 10.16438/j.0513-4870.2023-0805
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Disintegration time is a key parameter that affects the palatability and compliance of oral soluble films. At present, there is no standard method to determine the disintegration time of oral soluble films. In this study, we compared the six methods (pharmacopoeial disintegration method, petri dish method, sponge surface method, slide frame and ball method, partially immersed into liquid (without weight attached) and partially immersed into liquid (with weight attached)) to determine the in vitro disintegration time of oral soluble films with different thickness, and evaluated the correlation with the in vivo disintegration time. The results showed that the repeatability and correlation of pharmacopoeial disintegration method and the partially immersed into liquid method (with weight attached) were excellent, with the endpoint of disintegration testing easy to determine. Partially immersed into liquid method (with weight attached), properly simulating the physiological condition in oral cavity, showed strong operability, good repeatability and in vitro-in vivo correlation, and was suitable for in vitro disintegration evaluation of oral soluble film dosage form. The adult sensory evaluation study was a research-based clinical trial conducted with informed consent from all subjects in accordance with the ethical requirements of Good Clinical Practice.

oral soluble film  /  disintegration time  /  repeatability  /  determination of the endpoint  /  in vitro-in vivo correlation
Di GAO, Guo-xiang LI, Shu-ye QI, Xue-ping WU, Chao-qiang XIAO, Shu-wang HE, Jie YANG, Wei-feng ZHANG. Comparative study on the methods to determine disintegration time of oral soluble films[J]. Acta Pharmaceutica Sinica, 2023 , 58 (11) : 3204 -3209 . DOI: 10.16438/j.0513-4870.2023-0805
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Year 2023 volume 58 Issue 11
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Article Info
doi: 10.16438/j.0513-4870.2023-0805
  • Receive Date：2023-06-29
  • Online Date：2025-11-21
  • Published：2023-11-12
Article Data
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History
  • Received：2023-06-29
  • Revised：2023-08-31
Funding
Affiliations
    1. Beijing DYNE High-tech Pediatric Pharmaceutical R&D Institute Co., Ltd., Beijing 100176, China
    2. National Institutes for Food and Drug Control, Beijing 102629, China
    3. Shandong DYNE Marine Biopharmaceutical Co., Ltd., Weihai 264300, 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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Genus		 种数
Number of
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Percentage of total
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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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