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Extemporaneously compounded liquid formulations of clofazimine
BACKGROUND: Clofazimine (CFZ) is routinely used worldwide for the treatment of leprosy and TB. However, no liquid or dispersible tablet formulations of CFZ are currently available commercially for patients with challenges ingesting soft gelatin capsules or solid formulations. The aim of this researc...
Autores principales: | , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
International Union Against Tuberculosis and Lung Disease
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9904399/ https://www.ncbi.nlm.nih.gov/pubmed/36853102 http://dx.doi.org/10.5588/ijtld.22.0331 |
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author | Taneja, R. Nahata, M. C. Scarim, J. Pande, P. G. Scarim, A. Hoddinott, G. Fourie, C. L. Jew, R. K. Schaaf, H. S. Hesseling, A. C. Garcia-Prats, A. J. |
author_facet | Taneja, R. Nahata, M. C. Scarim, J. Pande, P. G. Scarim, A. Hoddinott, G. Fourie, C. L. Jew, R. K. Schaaf, H. S. Hesseling, A. C. Garcia-Prats, A. J. |
author_sort | Taneja, R. |
collection | PubMed |
description | BACKGROUND: Clofazimine (CFZ) is routinely used worldwide for the treatment of leprosy and TB. However, no liquid or dispersible tablet formulations of CFZ are currently available commercially for patients with challenges ingesting soft gelatin capsules or solid formulations. The aim of this research was to develop stable extemporaneous liquid formulations of CFZ that can be stored at room temperature for several weeks to enable practical dosing in the field. METHODS: Two formulations were prepared in syrup and sugar-free vehicles with CFZ tablets using a simple method that can be used in a routine pharmacy. Suspensions were stored at room temperature and at 30°C for 30 days. Formulation aliquots were tested on Days 0, 15 and 30 for appearance, pH, potency and microbial counts. RESULTS: Appearance remained unchanged during storage. The pH of both formulations was between 4.0 and 6.0. Potency was between 90% and 110% for 30 days in the syrup formulation and for 15 days in the sugar-free formulation. Microbial counts met United States Pharmacopeia <1111> limits for oral aqueous liquids and specific organisms were absent. CONCLUSIONS: A simple field-friendly method was successfully developed for the preparation of CFZ liquid formulations using commonly available ingredients. This will permit practical dosing and titration for children and other patients with swallowing challenges. |
format | Online Article Text |
id | pubmed-9904399 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | International Union Against Tuberculosis and Lung Disease |
record_format | MEDLINE/PubMed |
spelling | pubmed-99043992023-02-09 Extemporaneously compounded liquid formulations of clofazimine Taneja, R. Nahata, M. C. Scarim, J. Pande, P. G. Scarim, A. Hoddinott, G. Fourie, C. L. Jew, R. K. Schaaf, H. S. Hesseling, A. C. Garcia-Prats, A. J. Int J Tuberc Lung Dis Original Articles BACKGROUND: Clofazimine (CFZ) is routinely used worldwide for the treatment of leprosy and TB. However, no liquid or dispersible tablet formulations of CFZ are currently available commercially for patients with challenges ingesting soft gelatin capsules or solid formulations. The aim of this research was to develop stable extemporaneous liquid formulations of CFZ that can be stored at room temperature for several weeks to enable practical dosing in the field. METHODS: Two formulations were prepared in syrup and sugar-free vehicles with CFZ tablets using a simple method that can be used in a routine pharmacy. Suspensions were stored at room temperature and at 30°C for 30 days. Formulation aliquots were tested on Days 0, 15 and 30 for appearance, pH, potency and microbial counts. RESULTS: Appearance remained unchanged during storage. The pH of both formulations was between 4.0 and 6.0. Potency was between 90% and 110% for 30 days in the syrup formulation and for 15 days in the sugar-free formulation. Microbial counts met United States Pharmacopeia <1111> limits for oral aqueous liquids and specific organisms were absent. CONCLUSIONS: A simple field-friendly method was successfully developed for the preparation of CFZ liquid formulations using commonly available ingredients. This will permit practical dosing and titration for children and other patients with swallowing challenges. International Union Against Tuberculosis and Lung Disease 2023-02 2023-02-01 /pmc/articles/PMC9904399/ /pubmed/36853102 http://dx.doi.org/10.5588/ijtld.22.0331 Text en © 2023 The Union https://creativecommons.org/licenses/by/4.0/This is an Open Access article distributed under the terms of the Creative Commons Attribution Licence (http://creativecommons.org/licenses/by/4.0 (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 | Original Articles Taneja, R. Nahata, M. C. Scarim, J. Pande, P. G. Scarim, A. Hoddinott, G. Fourie, C. L. Jew, R. K. Schaaf, H. S. Hesseling, A. C. Garcia-Prats, A. J. Extemporaneously compounded liquid formulations of clofazimine |
title | Extemporaneously compounded liquid formulations of clofazimine |
title_full | Extemporaneously compounded liquid formulations of clofazimine |
title_fullStr | Extemporaneously compounded liquid formulations of clofazimine |
title_full_unstemmed | Extemporaneously compounded liquid formulations of clofazimine |
title_short | Extemporaneously compounded liquid formulations of clofazimine |
title_sort | extemporaneously compounded liquid formulations of clofazimine |
topic | Original Articles |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9904399/ https://www.ncbi.nlm.nih.gov/pubmed/36853102 http://dx.doi.org/10.5588/ijtld.22.0331 |
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