Enteric Hard Capsules for Targeting the Small Intestine: Positive Correlation between In Vitro Disintegration and Dissolution Times

In this study, the potential for correlation between disintegration and dissolution performance of enteric-coated (EC) dosage forms was investigated. Different enteric hard shell capsule formulations containing caffeine as model drug were tested for disintegration (in a compendial disintegration tes...

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Autores principales: Fu, Maoqi, Al-Gousous, Jozef, Blechar, Johannes Andreas, Langguth, Peter
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2020
Materias:
Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7076532/
https://www.ncbi.nlm.nih.gov/pubmed/32028731
http://dx.doi.org/10.3390/pharmaceutics12020123
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author Fu, Maoqi
Al-Gousous, Jozef
Blechar, Johannes Andreas
Langguth, Peter
author_facet Fu, Maoqi
Al-Gousous, Jozef
Blechar, Johannes Andreas
Langguth, Peter
author_sort Fu, Maoqi
collection PubMed
description In this study, the potential for correlation between disintegration and dissolution performance of enteric-coated (EC) dosage forms was investigated. Different enteric hard shell capsule formulations containing caffeine as model drug were tested for disintegration (in a compendial disintegration tester) and for dissolution in both USP type I (basket) and type II (paddle) apparatuses using different media. Overall, good correlations were obtained. This was observed for both the basket and the paddle apparatus, indicating that the use of disintegration testing as a surrogate for dissolution testing (allowed by International Conference on Harmonization (ICH) for immediate release dosage forms in case, in addition to other conditions, a correlation between disintegration and dissolution is proven) could be extended to include delayed release dosage forms.
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spelling pubmed-70765322020-03-20 Enteric Hard Capsules for Targeting the Small Intestine: Positive Correlation between In Vitro Disintegration and Dissolution Times Fu, Maoqi Al-Gousous, Jozef Blechar, Johannes Andreas Langguth, Peter Pharmaceutics Article In this study, the potential for correlation between disintegration and dissolution performance of enteric-coated (EC) dosage forms was investigated. Different enteric hard shell capsule formulations containing caffeine as model drug were tested for disintegration (in a compendial disintegration tester) and for dissolution in both USP type I (basket) and type II (paddle) apparatuses using different media. Overall, good correlations were obtained. This was observed for both the basket and the paddle apparatus, indicating that the use of disintegration testing as a surrogate for dissolution testing (allowed by International Conference on Harmonization (ICH) for immediate release dosage forms in case, in addition to other conditions, a correlation between disintegration and dissolution is proven) could be extended to include delayed release dosage forms. MDPI 2020-02-03 /pmc/articles/PMC7076532/ /pubmed/32028731 http://dx.doi.org/10.3390/pharmaceutics12020123 Text en © 2020 by the authors. 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 (http://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Fu, Maoqi
Al-Gousous, Jozef
Blechar, Johannes Andreas
Langguth, Peter
Enteric Hard Capsules for Targeting the Small Intestine: Positive Correlation between In Vitro Disintegration and Dissolution Times
title Enteric Hard Capsules for Targeting the Small Intestine: Positive Correlation between In Vitro Disintegration and Dissolution Times
title_full Enteric Hard Capsules for Targeting the Small Intestine: Positive Correlation between In Vitro Disintegration and Dissolution Times
title_fullStr Enteric Hard Capsules for Targeting the Small Intestine: Positive Correlation between In Vitro Disintegration and Dissolution Times
title_full_unstemmed Enteric Hard Capsules for Targeting the Small Intestine: Positive Correlation between In Vitro Disintegration and Dissolution Times
title_short Enteric Hard Capsules for Targeting the Small Intestine: Positive Correlation between In Vitro Disintegration and Dissolution Times
title_sort enteric hard capsules for targeting the small intestine: positive correlation between in vitro disintegration and dissolution times
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7076532/
https://www.ncbi.nlm.nih.gov/pubmed/32028731
http://dx.doi.org/10.3390/pharmaceutics12020123
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