In vitro evaluation of saxagliptin and metformin hydrochloride sustained-release tablets
10.11665/j.issn.1000-5048.20210505
- VernacularTitle:沙格列汀二甲双胍缓释片的体外评价
- Author:
Zhenming LI
1
;
Meirong HUO
;
Qidan DENG
;
Dengjun CHEN
;
Hongzhang SUN
Author Information
1. 中国药科大学药学院药剂系
- Publication Type:Journal Article
- Keywords:
saxagliptin;
metformin;
sustained-release tablets;
in vitro evaluation;
bioequivalence;
dissolution;
gel morphology;
gel strength
- From:
Journal of China Pharmaceutical University
2021;52(5):541-546
- CountryChina
- Language:Chinese
-
Abstract:
In order to evaluate the consistency of the release behavior between the self-made saxagliptin and metformin hydrochloride sustained-release tablets and the reference preparations in vitro, the similarity of the dissolution curves between the self-made preparations and the reference preparations in four dissolution mediums: HCl (pH 1.0), acetate buffer saline (pH 4.5), phosphate buffer saline (pH 6.8) and pure water, and the gel morphology and strength of the self-made preparations and the reference preparations in the HCl (pH 1.0) solution medium were compared.Results showed that in four dissolution mediums, the dissolution rates of saxagliptin in the self-made preparations and the reference preparations at 15 min were greater than 85%, and the ?2 similarity factors of metformin hydrochloride were 89, 83, 80, 86, all greater than 50, so the dissolution of the self-made preparations was consistent with those of the reference preparations.The volume expansion rate, water absorption rate and erosion rate were consistent with those of the reference preparations, and the gel strength of the self-made preparations was the same as that of the reference preparations.The in vitro release behaviors of the self-made preparations and the reference preparations are consistent, which provide a good guarantee for bioequivalence.
