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Comparing Two Methods of Tablet Manipulation to Adjust the Warfarin Dose in Paediatric Care

Tablets containing prescribed doses are not always available, and this is of particular importance in paediatric care where suitable age-appropriate formulations are generally lacking. To obtain a child-adjusted dose, tablets are manipulated in several ways; e.g., they may be dispersed in water befo...

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Autores principales: Brustugun, Jørgen, Birkedal Aas, Elisabeth, Tho, Ingunn, Bjerknes, Kathrin
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7238213/
https://www.ncbi.nlm.nih.gov/pubmed/32325777
http://dx.doi.org/10.3390/pharmaceutics12040375
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author Brustugun, Jørgen
Birkedal Aas, Elisabeth
Tho, Ingunn
Bjerknes, Kathrin
author_facet Brustugun, Jørgen
Birkedal Aas, Elisabeth
Tho, Ingunn
Bjerknes, Kathrin
author_sort Brustugun, Jørgen
collection PubMed
description Tablets containing prescribed doses are not always available, and this is of particular importance in paediatric care where suitable age-appropriate formulations are generally lacking. To obtain a child-adjusted dose, tablets are manipulated in several ways; e.g., they may be dispersed in water before a fraction is extracted, or they may be split before the resulting fragment is dispersed. In this study, the accuracy attained through these manipulation methods was investigated for two generic tablets containing the anticoagulant warfarin. Tablets were dispersed in water (10 mL) before a fraction (10%) was withdrawn, alternatively tablets were split in half or quarter fragments before the fragments were dispersed in water. To investigate the contribution of variability from the different steps in the manipulation processes, the amount of warfarin recovered from the various dispersions was determined, as was the accuracy of the splitting. A validated UHPLC-method was used for quantitative determination of warfarin. Splitting of the tablets could result in deviation >30% from the ideal, theoretical weight. The amount of drug substance extracted as a fraction from the dispersed tablets deviated no more than 10% from the intended amount. To obtain the most accurate child-adjusted fraction dose of warfarin, the tablets investigated in this study should be dispersed and the desired proportion extracted. Practices that involve splitting tablets are likely to increase the variation, and should be avoided.
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spelling pubmed-72382132020-05-28 Comparing Two Methods of Tablet Manipulation to Adjust the Warfarin Dose in Paediatric Care Brustugun, Jørgen Birkedal Aas, Elisabeth Tho, Ingunn Bjerknes, Kathrin Pharmaceutics Article Tablets containing prescribed doses are not always available, and this is of particular importance in paediatric care where suitable age-appropriate formulations are generally lacking. To obtain a child-adjusted dose, tablets are manipulated in several ways; e.g., they may be dispersed in water before a fraction is extracted, or they may be split before the resulting fragment is dispersed. In this study, the accuracy attained through these manipulation methods was investigated for two generic tablets containing the anticoagulant warfarin. Tablets were dispersed in water (10 mL) before a fraction (10%) was withdrawn, alternatively tablets were split in half or quarter fragments before the fragments were dispersed in water. To investigate the contribution of variability from the different steps in the manipulation processes, the amount of warfarin recovered from the various dispersions was determined, as was the accuracy of the splitting. A validated UHPLC-method was used for quantitative determination of warfarin. Splitting of the tablets could result in deviation >30% from the ideal, theoretical weight. The amount of drug substance extracted as a fraction from the dispersed tablets deviated no more than 10% from the intended amount. To obtain the most accurate child-adjusted fraction dose of warfarin, the tablets investigated in this study should be dispersed and the desired proportion extracted. Practices that involve splitting tablets are likely to increase the variation, and should be avoided. MDPI 2020-04-18 /pmc/articles/PMC7238213/ /pubmed/32325777 http://dx.doi.org/10.3390/pharmaceutics12040375 Text en © 2020 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
Brustugun, Jørgen
Birkedal Aas, Elisabeth
Tho, Ingunn
Bjerknes, Kathrin
Comparing Two Methods of Tablet Manipulation to Adjust the Warfarin Dose in Paediatric Care
title Comparing Two Methods of Tablet Manipulation to Adjust the Warfarin Dose in Paediatric Care
title_full Comparing Two Methods of Tablet Manipulation to Adjust the Warfarin Dose in Paediatric Care
title_fullStr Comparing Two Methods of Tablet Manipulation to Adjust the Warfarin Dose in Paediatric Care
title_full_unstemmed Comparing Two Methods of Tablet Manipulation to Adjust the Warfarin Dose in Paediatric Care
title_short Comparing Two Methods of Tablet Manipulation to Adjust the Warfarin Dose in Paediatric Care
title_sort comparing two methods of tablet manipulation to adjust the warfarin dose in paediatric care
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7238213/
https://www.ncbi.nlm.nih.gov/pubmed/32325777
http://dx.doi.org/10.3390/pharmaceutics12040375
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