Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2021 Aug 5:14:3499-3506.
doi: 10.2147/DMSO.S316187. eCollection 2021.

Dissolution Profile Evaluation of Eight Brands of Metformin Hydrochloride Tablets Available in Jimma, Southwest Ethiopia

Belachew Umeta  1 , Anbessa Bekele  1 , Tesfaye Mohammed  1   2 , Markos Duguma  2 , Henok Teshome  2 , Yimer Mekonnen  1   2
Affiliations

Dissolution Profile Evaluation of Eight Brands of Metformin Hydrochloride Tablets Available in Jimma, Southwest Ethiopia

Belachew Umeta et al. Diabetes Metab Syndr Obes. .

Abstract

Background: Dissolution is the critical quality control parameter and used to predict an in vivo oral bioavailability, and it is used to support bio-waiver.

Aim: To evaluate and compare the dissolution profile of eight brands of metformin HCL 500 mg tablets available in Jimma town, Southwest Ethiopia.

Methods: The study was conducted in Jimma town, Ethiopia. Eight (seven brands and one comparator) metformin HCL 500 mg tablets were included. The dissolution study was conducted as per United States Pharmacopeia, and the dissolution profile was compared by one-way ANOVA, model-dependent and model-independent approaches.

Results: All of the included tablet brands complied with single-point dissolution study specification. Statistical comparisons of the dissolution profile by one-way ANOVA revealed that all brands had similar dissolution profiles (p=0.89). All of the brands had a similarity factor (f2) >50% and the difference factor (f1) <15. The entire brands followed the Weibull curve approach (the highest coefficient of determination and lowest Akaike Information Criteria) for the release of an active pharmaceutical ingredient.

Conclusion: All of the brands complied with single point dissolution study and all of them could be used interchangeably with the innovator drug. All brands followed the Weibull method for the release of the drug substance.

Keywords: Jimma; biopharmaceutical classification; dissolution; metformin hydrochloride.

PubMed Disclaimer

Conflict of interest statement

The authors report no conflicts of interest in this work.

Figures

Figure 1
Figure 1
Chemical structure of metformin hydrochloride.
Figure 2
Figure 2
Calibration curve for dissolution study of metformin hydrochloride 500 mg tablets tested, 2019/2020.
Figure 3
Figure 3
Dissolution profile (mean, n=6) of metformin hydrochloride 500 mg tablets included in the study, 2019.
See this image and copyright information in PMC

References

    1. Roglic G. WHO Global report on diabetes: a summary. Int J Noncommun Dis. 2016;1(1):3. doi:10.4103/2468-8827.184853 - DOI
    1. Whiting DR, Guariguata L, Weil C, Shaw J. IDF diabetes atlas: global estimates of the prevalence of diabetes for 2011 and 2030. Diabetes Res Clin Pract. 2011;94(3):311–321. doi:10.1016/j.diabres.2011.10.029 - DOI - PubMed
    1. World Health Organization. World Malaria Report 2015. World Health Organization; 2016.
    1. Forouhi NG, Wareham NJ. Epidemiology of diabetes. Medicine (Abingdon). 2014;42(12):698–702. doi:10.1016/j.mpmed.2014.09.007 - DOI - PMC - PubMed
    1. World Health Organization. Classification of diabetes mellitus. World Health Organization; 2019. Available from: https://www.who.int/publications/i/item/classification-of-diabetes-mellitus.