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Capsule shell material impacts the in vitro disintegration and dissolution behaviour of a green tea extract()

PURPOSE: In vitro disintegration and dissolution are routine methods used to assess the performance and quality of oral dosage forms. The purpose of the current work was to determine the potential for interaction between capsule shell material and a green tea extract and the impact it can have on th...

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Detalles Bibliográficos
Autores principales: Glube, Natalie, Moos, Lea von, Duchateau, Guus
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier 2013
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3940125/
https://www.ncbi.nlm.nih.gov/pubmed/25755998
http://dx.doi.org/10.1016/j.rinphs.2013.08.002
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author Glube, Natalie
Moos, Lea von
Duchateau, Guus
author_facet Glube, Natalie
Moos, Lea von
Duchateau, Guus
author_sort Glube, Natalie
collection PubMed
description PURPOSE: In vitro disintegration and dissolution are routine methods used to assess the performance and quality of oral dosage forms. The purpose of the current work was to determine the potential for interaction between capsule shell material and a green tea extract and the impact it can have on the release. METHODS: A green tea extract was formulated into simple powder-in-capsule formulations of which the capsule shell material was either of gelatin or HPMC origin. The disintegration times were determined together with the dissolution profiles in compendial and biorelevant media. RESULTS: All formulations disintegrated within 30 min, meeting the USP criteria for botanical formulations. An immediate release dissolution profile was achieved for gelatin capsules in all media but not for the specified HPMC formulations. Dissolution release was especially impaired for HPMC(gell) at pH 1.2 and for both HPMC formulations in FeSSIF media suggesting the potential for food interactions. CONCLUSIONS: The delayed release from studied HPMC capsule materials is likely attributed to an interaction between the catechins, the major constituents of the green tea extract, and the capsule shell material. An assessment of in vitro dissolution is recommended prior to the release of a dietary supplement or clinical trial investigational product to ensure efficacy.
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spelling pubmed-39401252015-03-09 Capsule shell material impacts the in vitro disintegration and dissolution behaviour of a green tea extract() Glube, Natalie Moos, Lea von Duchateau, Guus Results Pharma Sci Article PURPOSE: In vitro disintegration and dissolution are routine methods used to assess the performance and quality of oral dosage forms. The purpose of the current work was to determine the potential for interaction between capsule shell material and a green tea extract and the impact it can have on the release. METHODS: A green tea extract was formulated into simple powder-in-capsule formulations of which the capsule shell material was either of gelatin or HPMC origin. The disintegration times were determined together with the dissolution profiles in compendial and biorelevant media. RESULTS: All formulations disintegrated within 30 min, meeting the USP criteria for botanical formulations. An immediate release dissolution profile was achieved for gelatin capsules in all media but not for the specified HPMC formulations. Dissolution release was especially impaired for HPMC(gell) at pH 1.2 and for both HPMC formulations in FeSSIF media suggesting the potential for food interactions. CONCLUSIONS: The delayed release from studied HPMC capsule materials is likely attributed to an interaction between the catechins, the major constituents of the green tea extract, and the capsule shell material. An assessment of in vitro dissolution is recommended prior to the release of a dietary supplement or clinical trial investigational product to ensure efficacy. Elsevier 2013-09-13 /pmc/articles/PMC3940125/ /pubmed/25755998 http://dx.doi.org/10.1016/j.rinphs.2013.08.002 Text en © 2013 The Authors http://creativecommons.org/licenses/by-nc-sa/3.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike License, which permits non-commercial use, distribution, and reproduction in any medium, provided the original author and source are credited.
spellingShingle Article
Glube, Natalie
Moos, Lea von
Duchateau, Guus
Capsule shell material impacts the in vitro disintegration and dissolution behaviour of a green tea extract()
title Capsule shell material impacts the in vitro disintegration and dissolution behaviour of a green tea extract()
title_full Capsule shell material impacts the in vitro disintegration and dissolution behaviour of a green tea extract()
title_fullStr Capsule shell material impacts the in vitro disintegration and dissolution behaviour of a green tea extract()
title_full_unstemmed Capsule shell material impacts the in vitro disintegration and dissolution behaviour of a green tea extract()
title_short Capsule shell material impacts the in vitro disintegration and dissolution behaviour of a green tea extract()
title_sort capsule shell material impacts the in vitro disintegration and dissolution behaviour of a green tea extract()
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3940125/
https://www.ncbi.nlm.nih.gov/pubmed/25755998
http://dx.doi.org/10.1016/j.rinphs.2013.08.002
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