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Quality Attributes and In Vitro Bioequivalence of Different Brands of Amoxicillin Trihydrate Tablets

Bacterial resistance and antibiotic drug effectiveness can be related to administering generic products with a subtherapeutic dose or poor in vivo drug release. The aim of this study was to investigate whether locally marketed amoxicillin tablets have the required chemical and physical attributes, i...

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Autores principales: Al-Tabakha, Moawia M., Fahelelbom, Khairi M. S., Obaid, Dana Emad Eddin, Sayed, Sadik
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5489935/
https://www.ncbi.nlm.nih.gov/pubmed/28531119
http://dx.doi.org/10.3390/pharmaceutics9020018
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author Al-Tabakha, Moawia M.
Fahelelbom, Khairi M. S.
Obaid, Dana Emad Eddin
Sayed, Sadik
author_facet Al-Tabakha, Moawia M.
Fahelelbom, Khairi M. S.
Obaid, Dana Emad Eddin
Sayed, Sadik
author_sort Al-Tabakha, Moawia M.
collection PubMed
description Bacterial resistance and antibiotic drug effectiveness can be related to administering generic products with a subtherapeutic dose or poor in vivo drug release. The aim of this study was to investigate whether locally marketed amoxicillin tablets have the required chemical and physical attributes, including in vitro bioequivalence performance. Five generic products (T1, T2, T3, T4, and T5) containing combination of amoxicillin trihydrate and potassium clavulanate as 1 g strength present in immediate release tablets were compared to the reference listed drug product Augmentin(®) (R) for weight variation, friability, resistance to crushing, and chemical content of amoxicillin. Difference (f(1)) and similarity (f(2)) factors were calculated to assess in vitro bioequivalence requirements. The tablets from different products have shown compliance with the pharmacopeial requirements of the performed tests. The measured resistance to crushing of tablets did not influence the dissolution time. Three generic products released more than 85% of amoxicillin by the first 15 min as did the reference product and were considered as bioequivalent products. T1 and T4 had f(1) values of 16.5% and 25.4% respectively and their f(2) values were 44.5 and 34.6 respectively, indicating failure to meet in vitro bioequivalence requirements. Tablet formulations can play an important role in achieving bioequivalence. Independent investigations such as this study serve as an important tool to reveal possible inferior or noncompliant products that may find their way to the market.
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spelling pubmed-54899352017-06-30 Quality Attributes and In Vitro Bioequivalence of Different Brands of Amoxicillin Trihydrate Tablets Al-Tabakha, Moawia M. Fahelelbom, Khairi M. S. Obaid, Dana Emad Eddin Sayed, Sadik Pharmaceutics Article Bacterial resistance and antibiotic drug effectiveness can be related to administering generic products with a subtherapeutic dose or poor in vivo drug release. The aim of this study was to investigate whether locally marketed amoxicillin tablets have the required chemical and physical attributes, including in vitro bioequivalence performance. Five generic products (T1, T2, T3, T4, and T5) containing combination of amoxicillin trihydrate and potassium clavulanate as 1 g strength present in immediate release tablets were compared to the reference listed drug product Augmentin(®) (R) for weight variation, friability, resistance to crushing, and chemical content of amoxicillin. Difference (f(1)) and similarity (f(2)) factors were calculated to assess in vitro bioequivalence requirements. The tablets from different products have shown compliance with the pharmacopeial requirements of the performed tests. The measured resistance to crushing of tablets did not influence the dissolution time. Three generic products released more than 85% of amoxicillin by the first 15 min as did the reference product and were considered as bioequivalent products. T1 and T4 had f(1) values of 16.5% and 25.4% respectively and their f(2) values were 44.5 and 34.6 respectively, indicating failure to meet in vitro bioequivalence requirements. Tablet formulations can play an important role in achieving bioequivalence. Independent investigations such as this study serve as an important tool to reveal possible inferior or noncompliant products that may find their way to the market. MDPI 2017-05-20 /pmc/articles/PMC5489935/ /pubmed/28531119 http://dx.doi.org/10.3390/pharmaceutics9020018 Text en © 2017 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (http://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Al-Tabakha, Moawia M.
Fahelelbom, Khairi M. S.
Obaid, Dana Emad Eddin
Sayed, Sadik
Quality Attributes and In Vitro Bioequivalence of Different Brands of Amoxicillin Trihydrate Tablets
title Quality Attributes and In Vitro Bioequivalence of Different Brands of Amoxicillin Trihydrate Tablets
title_full Quality Attributes and In Vitro Bioequivalence of Different Brands of Amoxicillin Trihydrate Tablets
title_fullStr Quality Attributes and In Vitro Bioequivalence of Different Brands of Amoxicillin Trihydrate Tablets
title_full_unstemmed Quality Attributes and In Vitro Bioequivalence of Different Brands of Amoxicillin Trihydrate Tablets
title_short Quality Attributes and In Vitro Bioequivalence of Different Brands of Amoxicillin Trihydrate Tablets
title_sort quality attributes and in vitro bioequivalence of different brands of amoxicillin trihydrate tablets
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5489935/
https://www.ncbi.nlm.nih.gov/pubmed/28531119
http://dx.doi.org/10.3390/pharmaceutics9020018
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