Comparative study on the methods to determine disintegration time of oral soluble films
10.16438/j.0513-4870.2023-0805
- VernacularTitle:口溶膜崩解时限评价方法对比研究
- Author:
Di GAO
1
;
Guo-xiang LI
1
;
Shu-ye QI
2
;
Xue-ping WU
3
;
Chao-qiang XIAO
4
;
Shu-wang HE
4
;
Jie YANG
4
;
Wei-feng ZHANG
4
Author Information
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
4. Beijing DYNE High-tech Pediatric Pharmaceutical R&D Institute Co., Ltd., Beijing 100176, China; Shandong DYNE Marine Biopharmaceutical Co., Ltd., Weihai 264300, China
- Publication Type:Research Article
- Keywords:
oral soluble film;
isintegration time;
repeatability;
etermination of the endpoint;
italic>in vitro-in vivo correlation
- From:
Acta Pharmaceutica Sinica
2023;58(11):3204-3209
- CountryChina
- Language:Chinese
-
Abstract:
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.
