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Evidence of Reliable Gastro-Resistance of Novel Enteric Ready-to-Fill Capsules Simplifying Pharmaceutical Manufacturing

Developing delayed-release formulations for acid-sensitive actives can be a costly and time-consuming process. However, ready-to-fill functional capsules, such as EUDRACAP(®) can significantly mitigate these challenges. The in vitro performance of EUDRACAP(®) enteric was evaluated in two typical del...

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Autores principales: Afonso Urich, Jesús Alberto, Fedorko, Anna, Hölzer, Bettina, Khinast, Johannes
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10675293/
https://www.ncbi.nlm.nih.gov/pubmed/38004571
http://dx.doi.org/10.3390/pharmaceutics15112592
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author Afonso Urich, Jesús Alberto
Fedorko, Anna
Hölzer, Bettina
Khinast, Johannes
author_facet Afonso Urich, Jesús Alberto
Fedorko, Anna
Hölzer, Bettina
Khinast, Johannes
author_sort Afonso Urich, Jesús Alberto
collection PubMed
description Developing delayed-release formulations for acid-sensitive actives can be a costly and time-consuming process. However, ready-to-fill functional capsules, such as EUDRACAP(®) can significantly mitigate these challenges. The in vitro performance of EUDRACAP(®) enteric was evaluated in two typical delayed-release scenarios: for diclofenac (a drug that can cause irritation to gastric mucosa), and for omeprazole (a drug susceptible to degradation due to the acidity of gastric fluid). The prototypes were tested in HCl 0.1N according to the USP <711> for at least 2 h and compared to commercial products. The results showed that the performance of EUDRACAP(®) was below LOD and in compliance with the requirements for drug release in acidic media (NMT 10%). Additionally, the impurities were evaluated after the acidic stress. The low total percentage of impurities of 0.44% for diclofenac (NMT 1.50%) and 0.22% for omeprazole (NMT 2.00%) indicates a very good protection by EUDRACAP(®). A comprehensive comparative analysis of the in vitro performance clearly showed the acid protection capability of EUDRACAP(®) enteric capsules making them a serious alternative to existing enteric dosage forms alternatives. EUDRACAP(®) is an accessible solution both in large-scale industrial and smaller pharmacy settings. Offering increased accessibility, affordability, and convenience to manufacturers and consumers alike and leading to improved healthcare outcomes.
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spelling pubmed-106752932023-11-06 Evidence of Reliable Gastro-Resistance of Novel Enteric Ready-to-Fill Capsules Simplifying Pharmaceutical Manufacturing Afonso Urich, Jesús Alberto Fedorko, Anna Hölzer, Bettina Khinast, Johannes Pharmaceutics Article Developing delayed-release formulations for acid-sensitive actives can be a costly and time-consuming process. However, ready-to-fill functional capsules, such as EUDRACAP(®) can significantly mitigate these challenges. The in vitro performance of EUDRACAP(®) enteric was evaluated in two typical delayed-release scenarios: for diclofenac (a drug that can cause irritation to gastric mucosa), and for omeprazole (a drug susceptible to degradation due to the acidity of gastric fluid). The prototypes were tested in HCl 0.1N according to the USP <711> for at least 2 h and compared to commercial products. The results showed that the performance of EUDRACAP(®) was below LOD and in compliance with the requirements for drug release in acidic media (NMT 10%). Additionally, the impurities were evaluated after the acidic stress. The low total percentage of impurities of 0.44% for diclofenac (NMT 1.50%) and 0.22% for omeprazole (NMT 2.00%) indicates a very good protection by EUDRACAP(®). A comprehensive comparative analysis of the in vitro performance clearly showed the acid protection capability of EUDRACAP(®) enteric capsules making them a serious alternative to existing enteric dosage forms alternatives. EUDRACAP(®) is an accessible solution both in large-scale industrial and smaller pharmacy settings. Offering increased accessibility, affordability, and convenience to manufacturers and consumers alike and leading to improved healthcare outcomes. MDPI 2023-11-06 /pmc/articles/PMC10675293/ /pubmed/38004571 http://dx.doi.org/10.3390/pharmaceutics15112592 Text en © 2023 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
Afonso Urich, Jesús Alberto
Fedorko, Anna
Hölzer, Bettina
Khinast, Johannes
Evidence of Reliable Gastro-Resistance of Novel Enteric Ready-to-Fill Capsules Simplifying Pharmaceutical Manufacturing
title Evidence of Reliable Gastro-Resistance of Novel Enteric Ready-to-Fill Capsules Simplifying Pharmaceutical Manufacturing
title_full Evidence of Reliable Gastro-Resistance of Novel Enteric Ready-to-Fill Capsules Simplifying Pharmaceutical Manufacturing
title_fullStr Evidence of Reliable Gastro-Resistance of Novel Enteric Ready-to-Fill Capsules Simplifying Pharmaceutical Manufacturing
title_full_unstemmed Evidence of Reliable Gastro-Resistance of Novel Enteric Ready-to-Fill Capsules Simplifying Pharmaceutical Manufacturing
title_short Evidence of Reliable Gastro-Resistance of Novel Enteric Ready-to-Fill Capsules Simplifying Pharmaceutical Manufacturing
title_sort evidence of reliable gastro-resistance of novel enteric ready-to-fill capsules simplifying pharmaceutical manufacturing
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10675293/
https://www.ncbi.nlm.nih.gov/pubmed/38004571
http://dx.doi.org/10.3390/pharmaceutics15112592
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