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Quality-by-design based fabrication of febuxostat-loaded nanoemulsion: Statistical optimization, characterizations, permeability, and bioavailability studies

The present work deals with QbD-based development of FEB-loaded nanoemulsion (FEB-NE) in order to enhance bioavailability and permeability. In the beginning, the risk assessment was performed on different experimental variables using the Ishikawa diagram followed by FMEA study in order to find criti...

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Autores principales: Gurumukhi, Vishal C., Sonawane, Vivek P., Tapadiya, Ganesh G., Bari, Sanjaykumar B., Surana, Sanjay J., Chalikwar, Shailesh S.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10148101/
https://www.ncbi.nlm.nih.gov/pubmed/37128342
http://dx.doi.org/10.1016/j.heliyon.2023.e15404
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author Gurumukhi, Vishal C.
Sonawane, Vivek P.
Tapadiya, Ganesh G.
Bari, Sanjaykumar B.
Surana, Sanjay J.
Chalikwar, Shailesh S.
author_facet Gurumukhi, Vishal C.
Sonawane, Vivek P.
Tapadiya, Ganesh G.
Bari, Sanjaykumar B.
Surana, Sanjay J.
Chalikwar, Shailesh S.
author_sort Gurumukhi, Vishal C.
collection PubMed
description The present work deals with QbD-based development of FEB-loaded nanoemulsion (FEB-NE) in order to enhance bioavailability and permeability. In the beginning, the risk assessment was performed on different experimental variables using the Ishikawa diagram followed by FMEA study in order to find critical process parameter (CPP) and critical material attributes (CMAs). To build quality in nanoemulsion, the quality target product profiles (QTPP) and critical quality attributes (CQAs) were determined. The different batches of FEB-NE were produced by the microemulsification-probe sonication method. Effect of varying levels of independent variables such as oil concentration (X(1)), S(mix) concentration (X(3)), and amplitude (X(3)) on responses such as globule size (Y(1)), zeta potential (Y(2)), and entrapment efficiency (Y(3)) were studied using Box-Behnken design (BDD). FEB-NE formulation was optimized using a graphical and numerical method. The optimized formulation concentrations and their responses (CQAs) were located as design space in an overlay plot. The spherical shapes of globules were visualized by surface morphology using AFM and TEM. In vitro dissolution study showed 93.32% drug release from the optimized FEB-NE formulation. The drug release mechanism followed by the formulation was the Higuchi-matrix kinetics with a regression coefficient of 0.9236 (R(2)). FEB-NE showed enhanced permeability using PAMPA (artificial non-cell membrane) and everted gut sac model method. The developed optimized FEB-NE exhibited the enhancement of bioavailability by 2.48 fold as compared to FEB-suspension using Wistar rats suggesting improvement of solubility of a lipophilic drug. The optimized batch remained stable for 90 days at 4 °C and 25 °C. Thus, QbD-based development of FEB-NE can be useful for a better perspective on a commercial scale.
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spelling pubmed-101481012023-04-30 Quality-by-design based fabrication of febuxostat-loaded nanoemulsion: Statistical optimization, characterizations, permeability, and bioavailability studies Gurumukhi, Vishal C. Sonawane, Vivek P. Tapadiya, Ganesh G. Bari, Sanjaykumar B. Surana, Sanjay J. Chalikwar, Shailesh S. Heliyon Research Article The present work deals with QbD-based development of FEB-loaded nanoemulsion (FEB-NE) in order to enhance bioavailability and permeability. In the beginning, the risk assessment was performed on different experimental variables using the Ishikawa diagram followed by FMEA study in order to find critical process parameter (CPP) and critical material attributes (CMAs). To build quality in nanoemulsion, the quality target product profiles (QTPP) and critical quality attributes (CQAs) were determined. The different batches of FEB-NE were produced by the microemulsification-probe sonication method. Effect of varying levels of independent variables such as oil concentration (X(1)), S(mix) concentration (X(3)), and amplitude (X(3)) on responses such as globule size (Y(1)), zeta potential (Y(2)), and entrapment efficiency (Y(3)) were studied using Box-Behnken design (BDD). FEB-NE formulation was optimized using a graphical and numerical method. The optimized formulation concentrations and their responses (CQAs) were located as design space in an overlay plot. The spherical shapes of globules were visualized by surface morphology using AFM and TEM. In vitro dissolution study showed 93.32% drug release from the optimized FEB-NE formulation. The drug release mechanism followed by the formulation was the Higuchi-matrix kinetics with a regression coefficient of 0.9236 (R(2)). FEB-NE showed enhanced permeability using PAMPA (artificial non-cell membrane) and everted gut sac model method. The developed optimized FEB-NE exhibited the enhancement of bioavailability by 2.48 fold as compared to FEB-suspension using Wistar rats suggesting improvement of solubility of a lipophilic drug. The optimized batch remained stable for 90 days at 4 °C and 25 °C. Thus, QbD-based development of FEB-NE can be useful for a better perspective on a commercial scale. Elsevier 2023-04-18 /pmc/articles/PMC10148101/ /pubmed/37128342 http://dx.doi.org/10.1016/j.heliyon.2023.e15404 Text en © 2023 The Authors. Published by Elsevier Ltd. https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
spellingShingle Research Article
Gurumukhi, Vishal C.
Sonawane, Vivek P.
Tapadiya, Ganesh G.
Bari, Sanjaykumar B.
Surana, Sanjay J.
Chalikwar, Shailesh S.
Quality-by-design based fabrication of febuxostat-loaded nanoemulsion: Statistical optimization, characterizations, permeability, and bioavailability studies
title Quality-by-design based fabrication of febuxostat-loaded nanoemulsion: Statistical optimization, characterizations, permeability, and bioavailability studies
title_full Quality-by-design based fabrication of febuxostat-loaded nanoemulsion: Statistical optimization, characterizations, permeability, and bioavailability studies
title_fullStr Quality-by-design based fabrication of febuxostat-loaded nanoemulsion: Statistical optimization, characterizations, permeability, and bioavailability studies
title_full_unstemmed Quality-by-design based fabrication of febuxostat-loaded nanoemulsion: Statistical optimization, characterizations, permeability, and bioavailability studies
title_short Quality-by-design based fabrication of febuxostat-loaded nanoemulsion: Statistical optimization, characterizations, permeability, and bioavailability studies
title_sort quality-by-design based fabrication of febuxostat-loaded nanoemulsion: statistical optimization, characterizations, permeability, and bioavailability studies
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10148101/
https://www.ncbi.nlm.nih.gov/pubmed/37128342
http://dx.doi.org/10.1016/j.heliyon.2023.e15404
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