Visual feature extraction combining dissolution testing for the study of drug release behavior of gliclazide modified release tablets
10.16438/j.0513-4870.2024-0660
- VernacularTitle:结合可视化特征提取的格列齐特缓释片释药行为研究
- Author:
Si-yu CHEN
1
;
Ze-ya LI
1
;
Ping LI
2
;
Xin-qing ZHAO
2
;
Tao GONG
1
;
Li DENG
1
;
Zhi-rong ZHANG
1
Author Information
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
2. Sichuan Medical Products Administration Key Laboratory for Quality Research and Control of Chemical Medicine,Chengdu Institute for Drug Control,Chengdu
- Publication Type:Research Article
- Keywords:
gliclazide modified release tablet;
hydrogel matrix tablet;
visualization;
italic>in vitro dissolution;
fitted mathematical model
- From:
Acta Pharmaceutica Sinica
2025;60(1):225-231
- CountryChina
- Language:Chinese
-
Abstract:
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.
