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Analytical Quality by Design (AQbD) Approach to the Development of In Vitro Release Test for Topical Hydrogel

The aim of our study was to adapt the analytical quality by design (AQbD) approach to design an effective in vitro release test method using USP apparatus IV with a semi-solid adapter (SSA) for diclofenac sodium hydrogel. The analytical target profile (ATP) of the in vitro release test and ultra-hig...

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Autores principales: Szoleczky, Réka, Budai-Szűcs, Mária, Csányi, Erzsébet, Berkó, Szilvia, Tonka-Nagy, Péter, Csóka, Ildikó, Kovács, Anita
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9026520/
https://www.ncbi.nlm.nih.gov/pubmed/35456541
http://dx.doi.org/10.3390/pharmaceutics14040707
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author Szoleczky, Réka
Budai-Szűcs, Mária
Csányi, Erzsébet
Berkó, Szilvia
Tonka-Nagy, Péter
Csóka, Ildikó
Kovács, Anita
author_facet Szoleczky, Réka
Budai-Szűcs, Mária
Csányi, Erzsébet
Berkó, Szilvia
Tonka-Nagy, Péter
Csóka, Ildikó
Kovács, Anita
author_sort Szoleczky, Réka
collection PubMed
description The aim of our study was to adapt the analytical quality by design (AQbD) approach to design an effective in vitro release test method using USP apparatus IV with a semi-solid adapter (SSA) for diclofenac sodium hydrogel. The analytical target profile (ATP) of the in vitro release test and ultra-high-performance liquid chromatography were defined; the critical method attributes (CMAs) (min. 70% of the drug should be released during the test, six time points should be obtained in the linear portion of the drug release profile, and the relative standard deviation of the released drug should not be over 10%) were selected. An initial risk assessment was carried out, in which the CMAs (ionic strength, the pH of the media, membrane type, the rate of flow, the volume of the SSA (sample amount), the individual flow rate of cells, drug concentration %, and the composition of the product) were identified. With the results, it was possible to determine the high-risk parameters of the in vitro drug release studies performed with the USP apparatus IV with SSA, which were the pH of the medium and the sample weight of the product. Focusing on these parameters, we developed a test protocol for our hydrogel system.
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spelling pubmed-90265202022-04-23 Analytical Quality by Design (AQbD) Approach to the Development of In Vitro Release Test for Topical Hydrogel Szoleczky, Réka Budai-Szűcs, Mária Csányi, Erzsébet Berkó, Szilvia Tonka-Nagy, Péter Csóka, Ildikó Kovács, Anita Pharmaceutics Article The aim of our study was to adapt the analytical quality by design (AQbD) approach to design an effective in vitro release test method using USP apparatus IV with a semi-solid adapter (SSA) for diclofenac sodium hydrogel. The analytical target profile (ATP) of the in vitro release test and ultra-high-performance liquid chromatography were defined; the critical method attributes (CMAs) (min. 70% of the drug should be released during the test, six time points should be obtained in the linear portion of the drug release profile, and the relative standard deviation of the released drug should not be over 10%) were selected. An initial risk assessment was carried out, in which the CMAs (ionic strength, the pH of the media, membrane type, the rate of flow, the volume of the SSA (sample amount), the individual flow rate of cells, drug concentration %, and the composition of the product) were identified. With the results, it was possible to determine the high-risk parameters of the in vitro drug release studies performed with the USP apparatus IV with SSA, which were the pH of the medium and the sample weight of the product. Focusing on these parameters, we developed a test protocol for our hydrogel system. MDPI 2022-03-26 /pmc/articles/PMC9026520/ /pubmed/35456541 http://dx.doi.org/10.3390/pharmaceutics14040707 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
Szoleczky, Réka
Budai-Szűcs, Mária
Csányi, Erzsébet
Berkó, Szilvia
Tonka-Nagy, Péter
Csóka, Ildikó
Kovács, Anita
Analytical Quality by Design (AQbD) Approach to the Development of In Vitro Release Test for Topical Hydrogel
title Analytical Quality by Design (AQbD) Approach to the Development of In Vitro Release Test for Topical Hydrogel
title_full Analytical Quality by Design (AQbD) Approach to the Development of In Vitro Release Test for Topical Hydrogel
title_fullStr Analytical Quality by Design (AQbD) Approach to the Development of In Vitro Release Test for Topical Hydrogel
title_full_unstemmed Analytical Quality by Design (AQbD) Approach to the Development of In Vitro Release Test for Topical Hydrogel
title_short Analytical Quality by Design (AQbD) Approach to the Development of In Vitro Release Test for Topical Hydrogel
title_sort analytical quality by design (aqbd) approach to the development of in vitro release test for topical hydrogel
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9026520/
https://www.ncbi.nlm.nih.gov/pubmed/35456541
http://dx.doi.org/10.3390/pharmaceutics14040707
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