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The stability of quetiapine oral suspension compounded from commercially available tablets

Quetiapine fumarate (QF) is an atypical antipsychotic used off-label for the treatment of delirium in critically-ill infants and children. For the treatment of pediatric populations or patient populations with trouble swallowing tablets, an oral suspension would be an ideal dosage formulation. Howev...

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Autores principales: Tran, Jennie, Gervase, Melissa A., Evans, Jason, Deville, Rebecca, Dong, Xiaowei
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Public Library of Science 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8354457/
https://www.ncbi.nlm.nih.gov/pubmed/34375349
http://dx.doi.org/10.1371/journal.pone.0255963
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author Tran, Jennie
Gervase, Melissa A.
Evans, Jason
Deville, Rebecca
Dong, Xiaowei
author_facet Tran, Jennie
Gervase, Melissa A.
Evans, Jason
Deville, Rebecca
Dong, Xiaowei
author_sort Tran, Jennie
collection PubMed
description Quetiapine fumarate (QF) is an atypical antipsychotic used off-label for the treatment of delirium in critically-ill infants and children. For the treatment of pediatric populations or patient populations with trouble swallowing tablets, an oral suspension would be an ideal dosage formulation. However, there are no liquid formulations of QF commercially available. Therefore, a compounded oral suspension prepared from the commercial QF tablets is widely used in clinical settings. The extemporaneous preparation of QF compounded oral suspension changes the formulation from a solid form to a liquid form. Thus, the stability of QF compounded oral suspension should be critically evaluated to guide pharmacists for administration and storage of QF compounded oral suspensions. However, the stability of the nonaqueous oral QF suspension was not measured. The objective of this study was to develop QF compounded oral suspensions at 10 mg/mL by using commercial QF tablets in two readily available aqueous vehicles (Ora-Sweet and Ora-Blend) and measure their stability at both room temperature and under refrigeration. Physical stability of the QF compounded suspensions were evaluated by appearance and odor. Chemical stability of the QF compounded suspensions were evaluated based on pH, degradation, drug content and the amount of the drug dissolved in the vehicles. An HPLC method was validated and used to evaluate QF compounded suspensions over 60 days. In addition to the total drug in the suspensions, the dissolved drug in the vehicles was also measured during the stability testing and evaluated as a stability parameter. Overall, QF suspension prepared in Ora-Blend was preferable, demonstrating a superior 60-day stability at both room temperature and refrigerated storage.
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spelling pubmed-83544572021-08-11 The stability of quetiapine oral suspension compounded from commercially available tablets Tran, Jennie Gervase, Melissa A. Evans, Jason Deville, Rebecca Dong, Xiaowei PLoS One Research Article Quetiapine fumarate (QF) is an atypical antipsychotic used off-label for the treatment of delirium in critically-ill infants and children. For the treatment of pediatric populations or patient populations with trouble swallowing tablets, an oral suspension would be an ideal dosage formulation. However, there are no liquid formulations of QF commercially available. Therefore, a compounded oral suspension prepared from the commercial QF tablets is widely used in clinical settings. The extemporaneous preparation of QF compounded oral suspension changes the formulation from a solid form to a liquid form. Thus, the stability of QF compounded oral suspension should be critically evaluated to guide pharmacists for administration and storage of QF compounded oral suspensions. However, the stability of the nonaqueous oral QF suspension was not measured. The objective of this study was to develop QF compounded oral suspensions at 10 mg/mL by using commercial QF tablets in two readily available aqueous vehicles (Ora-Sweet and Ora-Blend) and measure their stability at both room temperature and under refrigeration. Physical stability of the QF compounded suspensions were evaluated by appearance and odor. Chemical stability of the QF compounded suspensions were evaluated based on pH, degradation, drug content and the amount of the drug dissolved in the vehicles. An HPLC method was validated and used to evaluate QF compounded suspensions over 60 days. In addition to the total drug in the suspensions, the dissolved drug in the vehicles was also measured during the stability testing and evaluated as a stability parameter. Overall, QF suspension prepared in Ora-Blend was preferable, demonstrating a superior 60-day stability at both room temperature and refrigerated storage. Public Library of Science 2021-08-10 /pmc/articles/PMC8354457/ /pubmed/34375349 http://dx.doi.org/10.1371/journal.pone.0255963 Text en © 2021 Tran et al https://creativecommons.org/licenses/by/4.0/This is an open access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/) , which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
spellingShingle Research Article
Tran, Jennie
Gervase, Melissa A.
Evans, Jason
Deville, Rebecca
Dong, Xiaowei
The stability of quetiapine oral suspension compounded from commercially available tablets
title The stability of quetiapine oral suspension compounded from commercially available tablets
title_full The stability of quetiapine oral suspension compounded from commercially available tablets
title_fullStr The stability of quetiapine oral suspension compounded from commercially available tablets
title_full_unstemmed The stability of quetiapine oral suspension compounded from commercially available tablets
title_short The stability of quetiapine oral suspension compounded from commercially available tablets
title_sort stability of quetiapine oral suspension compounded from commercially available tablets
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8354457/
https://www.ncbi.nlm.nih.gov/pubmed/34375349
http://dx.doi.org/10.1371/journal.pone.0255963
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