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Structural Characterization and Optimization of a Miconazole Oral Gel

The development of semisolid formulations, gels in particular, has raised the attention of scientists more and more over the last decades. Because of their biocompatibility, hydrophilic nature, and capacity of absorbing large quantities of water, hydrogels are still one of the most promising pharmac...

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Autores principales: Pintea, Andrada, Vlad, Robert-Alexandru, Antonoaea, Paula, Rédai, Emöke Margit, Todoran, Nicoleta, Barabás, Enikő-Csilla, Ciurba, Adriana
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9692734/
https://www.ncbi.nlm.nih.gov/pubmed/36433136
http://dx.doi.org/10.3390/polym14225011
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author Pintea, Andrada
Vlad, Robert-Alexandru
Antonoaea, Paula
Rédai, Emöke Margit
Todoran, Nicoleta
Barabás, Enikő-Csilla
Ciurba, Adriana
author_facet Pintea, Andrada
Vlad, Robert-Alexandru
Antonoaea, Paula
Rédai, Emöke Margit
Todoran, Nicoleta
Barabás, Enikő-Csilla
Ciurba, Adriana
author_sort Pintea, Andrada
collection PubMed
description The development of semisolid formulations, gels in particular, has raised the attention of scientists more and more over the last decades. Because of their biocompatibility, hydrophilic nature, and capacity of absorbing large quantities of water, hydrogels are still one of the most promising pharmaceutical formulations in the pharmaceutical industry. The purpose of this study is to develop an optimal formulation capable of incorporating a water-poorly soluble active ingredient such as miconazole used in the treatment of fungal infections with Candida albicans and Candida parapsilosis. A D-optimal design was applied to study the relationship between the formulation parameter and the gel characteristics. The independent parameters used in this study were the Carbopol 940 concentration (the polymer used to obtain the gel matrix), the sodium hydroxide amount, and the presence/absence of miconazole. Ten different dependent parameters (Y1–Y10) were evaluated (penetrometry, spreadability, viscosity, and tangential tension at 1 and 11 levels of speed whilst destructuring and during the reorganization of the gel matrix). The consistency of the gels ranged from 23.2 mm (GO2) to 29.6 mm (GM5). The least spreadable gel was GO7 (1384 mm(2)), whilst the gel that presented the best spreadability was GO1 (3525 mm(2)). The viscosity and the tangential stress at the selected levels (1 and 11) varied due to the different compositions of the proposed gels. The gels were also tested for drug content and antifungal activity. All determinations had satisfying results; the drug content was within limits accepted by Ph. Eur. 10 and all formulations containing miconazole exhibited antifungal activity. An optimal formulation with miconazole was attained, consisting of 0.84% Carbopol 940 and 0.32% sodium hydroxide.
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spelling pubmed-96927342022-11-26 Structural Characterization and Optimization of a Miconazole Oral Gel Pintea, Andrada Vlad, Robert-Alexandru Antonoaea, Paula Rédai, Emöke Margit Todoran, Nicoleta Barabás, Enikő-Csilla Ciurba, Adriana Polymers (Basel) Article The development of semisolid formulations, gels in particular, has raised the attention of scientists more and more over the last decades. Because of their biocompatibility, hydrophilic nature, and capacity of absorbing large quantities of water, hydrogels are still one of the most promising pharmaceutical formulations in the pharmaceutical industry. The purpose of this study is to develop an optimal formulation capable of incorporating a water-poorly soluble active ingredient such as miconazole used in the treatment of fungal infections with Candida albicans and Candida parapsilosis. A D-optimal design was applied to study the relationship between the formulation parameter and the gel characteristics. The independent parameters used in this study were the Carbopol 940 concentration (the polymer used to obtain the gel matrix), the sodium hydroxide amount, and the presence/absence of miconazole. Ten different dependent parameters (Y1–Y10) were evaluated (penetrometry, spreadability, viscosity, and tangential tension at 1 and 11 levels of speed whilst destructuring and during the reorganization of the gel matrix). The consistency of the gels ranged from 23.2 mm (GO2) to 29.6 mm (GM5). The least spreadable gel was GO7 (1384 mm(2)), whilst the gel that presented the best spreadability was GO1 (3525 mm(2)). The viscosity and the tangential stress at the selected levels (1 and 11) varied due to the different compositions of the proposed gels. The gels were also tested for drug content and antifungal activity. All determinations had satisfying results; the drug content was within limits accepted by Ph. Eur. 10 and all formulations containing miconazole exhibited antifungal activity. An optimal formulation with miconazole was attained, consisting of 0.84% Carbopol 940 and 0.32% sodium hydroxide. MDPI 2022-11-18 /pmc/articles/PMC9692734/ /pubmed/36433136 http://dx.doi.org/10.3390/polym14225011 Text en © 2022 by the authors. https://creativecommons.org/licenses/by/4.0/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 (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Pintea, Andrada
Vlad, Robert-Alexandru
Antonoaea, Paula
Rédai, Emöke Margit
Todoran, Nicoleta
Barabás, Enikő-Csilla
Ciurba, Adriana
Structural Characterization and Optimization of a Miconazole Oral Gel
title Structural Characterization and Optimization of a Miconazole Oral Gel
title_full Structural Characterization and Optimization of a Miconazole Oral Gel
title_fullStr Structural Characterization and Optimization of a Miconazole Oral Gel
title_full_unstemmed Structural Characterization and Optimization of a Miconazole Oral Gel
title_short Structural Characterization and Optimization of a Miconazole Oral Gel
title_sort structural characterization and optimization of a miconazole oral gel
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9692734/
https://www.ncbi.nlm.nih.gov/pubmed/36433136
http://dx.doi.org/10.3390/polym14225011
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