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Stability of Amoxicillin and Clavulanic Acid in Separate Containers for Administration via a Y-Site
RATIONALE: With the discovery of new antibiotics diminishing, optimising the administration of existing antibiotics such as amoxicillin-clavulanic acid has become a necessity. At present, the optimal approach for enhancing the effectiveness of time-dependent antibiotics involves extending the time a...
Autores principales: | , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Dove
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8464313/ https://www.ncbi.nlm.nih.gov/pubmed/34584403 http://dx.doi.org/10.2147/DDDT.S310418 |
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author | Fawaz, Sarah Merzouk, Mahboub Barton, Stephen Nabhani-Gebara, Shereen |
author_facet | Fawaz, Sarah Merzouk, Mahboub Barton, Stephen Nabhani-Gebara, Shereen |
author_sort | Fawaz, Sarah |
collection | PubMed |
description | RATIONALE: With the discovery of new antibiotics diminishing, optimising the administration of existing antibiotics such as amoxicillin-clavulanic acid has become a necessity. At present, the optimal approach for enhancing the effectiveness of time-dependent antibiotics involves extending the time at which antibiotic concentrations are maintained above the minimal inhibitory concentration by prolonging the infusion time. This pharmacodynamic rationale cannot be applied to co-amoxiclav because of poor stability at room temperature. The aim of this study was to establish the shelf-life of amoxicillin and clavulanic acid prepared in separate containers to determine the feasibility of 24-hr continuous infusion therapy. METHODS: A previously developed and validated stability-indicating HPLC method was used to establish the shelf-life of reconstituted amoxicillin and clavulanic acid when prepared in separate containers. Stability at clinical concentration was evaluated at three temperatures. To establish whether there were significant differences at the level of both active ingredients and temperature, results were analysed using analysis of covariance (ANCOVA) to assess differences between the attained slopes of regression. RESULTS: Data obtained indicated amoxicillin and clavulanic acid stability superior to that previously proposed making it suitable for continuous infusion therapy. Analysis of regression slopes via ANCOVA showed that temperature significantly affected amoxicillin and clavulanic acid stability. Amoxicillin retained 90% of its initial concentration for 80.3 hrs when stored at 4°C, 24.8 hrs at 25°C and 9 hrs when incubated at 37°C. Clavulanic acid retained 90% of its initial concentration for 152 hrs when stored at 4°C, 26 hrs at 25°C and 6.4 hrs when incubated at 37°C. CONCLUSION: Amoxicillin and clavulanic acid are suitable for administration via continuous infusion when prepared, stored, and administered in separate containers. Results obtained from this study aid in ameliorating current dosing regimens to optimise antibiotic efficacy; however, more in-depth amoxicillin and clavulanic acid y-site compatibility studies are warranted. |
format | Online Article Text |
id | pubmed-8464313 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | Dove |
record_format | MEDLINE/PubMed |
spelling | pubmed-84643132021-09-27 Stability of Amoxicillin and Clavulanic Acid in Separate Containers for Administration via a Y-Site Fawaz, Sarah Merzouk, Mahboub Barton, Stephen Nabhani-Gebara, Shereen Drug Des Devel Ther Original Research RATIONALE: With the discovery of new antibiotics diminishing, optimising the administration of existing antibiotics such as amoxicillin-clavulanic acid has become a necessity. At present, the optimal approach for enhancing the effectiveness of time-dependent antibiotics involves extending the time at which antibiotic concentrations are maintained above the minimal inhibitory concentration by prolonging the infusion time. This pharmacodynamic rationale cannot be applied to co-amoxiclav because of poor stability at room temperature. The aim of this study was to establish the shelf-life of amoxicillin and clavulanic acid prepared in separate containers to determine the feasibility of 24-hr continuous infusion therapy. METHODS: A previously developed and validated stability-indicating HPLC method was used to establish the shelf-life of reconstituted amoxicillin and clavulanic acid when prepared in separate containers. Stability at clinical concentration was evaluated at three temperatures. To establish whether there were significant differences at the level of both active ingredients and temperature, results were analysed using analysis of covariance (ANCOVA) to assess differences between the attained slopes of regression. RESULTS: Data obtained indicated amoxicillin and clavulanic acid stability superior to that previously proposed making it suitable for continuous infusion therapy. Analysis of regression slopes via ANCOVA showed that temperature significantly affected amoxicillin and clavulanic acid stability. Amoxicillin retained 90% of its initial concentration for 80.3 hrs when stored at 4°C, 24.8 hrs at 25°C and 9 hrs when incubated at 37°C. Clavulanic acid retained 90% of its initial concentration for 152 hrs when stored at 4°C, 26 hrs at 25°C and 6.4 hrs when incubated at 37°C. CONCLUSION: Amoxicillin and clavulanic acid are suitable for administration via continuous infusion when prepared, stored, and administered in separate containers. Results obtained from this study aid in ameliorating current dosing regimens to optimise antibiotic efficacy; however, more in-depth amoxicillin and clavulanic acid y-site compatibility studies are warranted. Dove 2021-09-21 /pmc/articles/PMC8464313/ /pubmed/34584403 http://dx.doi.org/10.2147/DDDT.S310418 Text en © 2021 Fawaz et al. https://creativecommons.org/licenses/by-nc/3.0/This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License (http://creativecommons.org/licenses/by-nc/3.0/ (https://creativecommons.org/licenses/by-nc/3.0/) ). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms (https://www.dovepress.com/terms.php). |
spellingShingle | Original Research Fawaz, Sarah Merzouk, Mahboub Barton, Stephen Nabhani-Gebara, Shereen Stability of Amoxicillin and Clavulanic Acid in Separate Containers for Administration via a Y-Site |
title | Stability of Amoxicillin and Clavulanic Acid in Separate Containers for Administration via a Y-Site |
title_full | Stability of Amoxicillin and Clavulanic Acid in Separate Containers for Administration via a Y-Site |
title_fullStr | Stability of Amoxicillin and Clavulanic Acid in Separate Containers for Administration via a Y-Site |
title_full_unstemmed | Stability of Amoxicillin and Clavulanic Acid in Separate Containers for Administration via a Y-Site |
title_short | Stability of Amoxicillin and Clavulanic Acid in Separate Containers for Administration via a Y-Site |
title_sort | stability of amoxicillin and clavulanic acid in separate containers for administration via a y-site |
topic | Original Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8464313/ https://www.ncbi.nlm.nih.gov/pubmed/34584403 http://dx.doi.org/10.2147/DDDT.S310418 |
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