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 Mekonnen1,2 1Department of Pharmaceutical Sciences, School of Pharmacy, Institute of Health, Jimma University, Jimma, Oromia, Ethiopia; 2Jimma University Laboratory of Drug Quality (JULaDQ), Jimma University...

Descripción completa

Guardado en:

Detalles Bibliográficos
Autores principales:	Umeta B, Bekele A, Mohammed T, Duguma M, Teshome H, Mekonnen Y
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2021
Materias:	dissolution jimma metformin hydrochloride biopharmaceutical classification Specialties of internal medicine RC581-951
Acceso en línea:	https://doaj.org/article/bbc08fe5b2e94326b784f5f6b9419806
Etiquetas:	Agregar Etiqueta Sin Etiquetas, Sea el primero en etiquetar este registro!

id	oai:doaj.org-article:bbc08fe5b2e94326b784f5f6b9419806
record_format	dspace
spelling	oai:doaj.org-article:bbc08fe5b2e94326b784f5f6b94198062021-12-02T16:16:09ZDissolution Profile Evaluation of Eight Brands of Metformin Hydrochloride Tablets Available in Jimma, Southwest Ethiopia1178-7007https://doaj.org/article/bbc08fe5b2e94326b784f5f6b94198062021-08-01T00:00:00Zhttps://www.dovepress.com/dissolution-profile-evaluation-of-eight-brands-of-metformin-hydrochlor-peer-reviewed-fulltext-article-DMSOhttps://doaj.org/toc/1178-7007Belachew Umeta,1 Anbessa Bekele,1 Tesfaye Mohammed,1,2 Markos Duguma,2 Henok Teshome,2 Yimer Mekonnen1,2 1Department of Pharmaceutical Sciences, School of Pharmacy, Institute of Health, Jimma University, Jimma, Oromia, Ethiopia; 2Jimma University Laboratory of Drug Quality (JULaDQ), Jimma University, Jimma, Oromia, EthiopiaCorrespondence: Belachew UmetaDepartment of Pharmaceutical Sciences, School of Pharmacy, Institute of Health, Jimma University, PO Box 378, Jimma, Oromia, EthiopiaTel +251901649597Email belachew.umeta@ju.edu.etBackground: 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: dissolution, Jimma, metformin hydrochloride, biopharmaceutical classificationUmeta BBekele AMohammed TDuguma MTeshome HMekonnen YDove Medical Pressarticledissolutionjimmametformin hydrochloridebiopharmaceutical classificationSpecialties of internal medicineRC581-951ENDiabetes, Metabolic Syndrome and Obesity: Targets and Therapy, Vol Volume 14, Pp 3499-3506 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	dissolution jimma metformin hydrochloride biopharmaceutical classification Specialties of internal medicine RC581-951
spellingShingle	dissolution jimma metformin hydrochloride biopharmaceutical classification Specialties of internal medicine RC581-951 Umeta B Bekele A Mohammed T Duguma M Teshome H Mekonnen Y Dissolution Profile Evaluation of Eight Brands of Metformin Hydrochloride Tablets Available in Jimma, Southwest Ethiopia
description	Belachew Umeta,1 Anbessa Bekele,1 Tesfaye Mohammed,1,2 Markos Duguma,2 Henok Teshome,2 Yimer Mekonnen1,2 1Department of Pharmaceutical Sciences, School of Pharmacy, Institute of Health, Jimma University, Jimma, Oromia, Ethiopia; 2Jimma University Laboratory of Drug Quality (JULaDQ), Jimma University, Jimma, Oromia, EthiopiaCorrespondence: Belachew UmetaDepartment of Pharmaceutical Sciences, School of Pharmacy, Institute of Health, Jimma University, PO Box 378, Jimma, Oromia, EthiopiaTel +251901649597Email belachew.umeta@ju.edu.etBackground: 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: dissolution, Jimma, metformin hydrochloride, biopharmaceutical classification
format	article
author	Umeta B Bekele A Mohammed T Duguma M Teshome H Mekonnen Y
author_facet	Umeta B Bekele A Mohammed T Duguma M Teshome H Mekonnen Y
author_sort	Umeta B
title	Dissolution Profile Evaluation of Eight Brands of Metformin Hydrochloride Tablets Available in Jimma, Southwest Ethiopia
title_short	Dissolution Profile Evaluation of Eight Brands of Metformin Hydrochloride Tablets Available in Jimma, Southwest Ethiopia
title_full	Dissolution Profile Evaluation of Eight Brands of Metformin Hydrochloride Tablets Available in Jimma, Southwest Ethiopia
title_fullStr	Dissolution Profile Evaluation of Eight Brands of Metformin Hydrochloride Tablets Available in Jimma, Southwest Ethiopia
title_full_unstemmed	Dissolution Profile Evaluation of Eight Brands of Metformin Hydrochloride Tablets Available in Jimma, Southwest Ethiopia
title_sort	dissolution profile evaluation of eight brands of metformin hydrochloride tablets available in jimma, southwest ethiopia
publisher	Dove Medical Press
publishDate	2021
url	https://doaj.org/article/bbc08fe5b2e94326b784f5f6b9419806
work_keys_str_mv	AT umetab dissolutionprofileevaluationofeightbrandsofmetforminhydrochloridetabletsavailableinjimmasouthwestethiopia AT bekelea dissolutionprofileevaluationofeightbrandsofmetforminhydrochloridetabletsavailableinjimmasouthwestethiopia AT mohammedt dissolutionprofileevaluationofeightbrandsofmetforminhydrochloridetabletsavailableinjimmasouthwestethiopia AT dugumam dissolutionprofileevaluationofeightbrandsofmetforminhydrochloridetabletsavailableinjimmasouthwestethiopia AT teshomeh dissolutionprofileevaluationofeightbrandsofmetforminhydrochloridetabletsavailableinjimmasouthwestethiopia AT mekonneny dissolutionprofileevaluationofeightbrandsofmetforminhydrochloridetabletsavailableinjimmasouthwestethiopia
_version_	1718384315573731328

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

Ejemplares similares