Performance Evaluation of a Novel Biosourced Co-Processed Excipient in Direct Compression and Drug Release

This study exposes the potential usefulness of a new co-processed excipient, composed of alginic acid and microcrystalline cellulose (Cop AA-MCC), for the preparation of immediate drug release tablets by direct compression. Evaluation of the physical and mechanical properties as well as the disinteg...

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Main Authors: Rihab Benabbas, Noelia M. Sanchez-Ballester, Adrien Aubert, Tahmer Sharkawi, Bernard Bataille, Ian Soulairol
Format: Article
Language:English
Published: MDPI AG 2021-03-01
Series:Polymers
Subjects:
Online Access:https://www.mdpi.com/2073-4360/13/6/988
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author Rihab Benabbas
Noelia M. Sanchez-Ballester
Adrien Aubert
Tahmer Sharkawi
Bernard Bataille
Ian Soulairol
author_facet Rihab Benabbas
Noelia M. Sanchez-Ballester
Adrien Aubert
Tahmer Sharkawi
Bernard Bataille
Ian Soulairol
author_sort Rihab Benabbas
collection DOAJ
description This study exposes the potential usefulness of a new co-processed excipient, composed of alginic acid and microcrystalline cellulose (Cop AA-MCC), for the preparation of immediate drug release tablets by direct compression. Evaluation of the physical and mechanical properties as well as the disintegration behavior of Cop AA-MCC in comparison to commercial co-processed excipients (Cellactose<sup>®</sup>, Ludipress<sup>®</sup>, Prosolv<sup>®</sup> SMCC HD90 and Prosolv<sup>®</sup> ODT) and to the physical mixture of the native excipients (MCC and AA), was carried out. The obtained results illustrate the good performance of Cop AA-MCC in terms of powder flowability, tablet tensile strength, compressibility, and disintegration time. Although, this new co-processed excipient showed a slightly high lubricant sensitivity, which was explained by its more plastic than fragmentary deformation behavior, it presented a low lubricant requirement due to the remarkably low ejection force observed during compression. Compression speed and dwell time seemed not to affect significantly the tabletability of Cop AA-MCC. The study exposed evenly the performance of Cop AA-MCC compared to Prosolv<sup>®</sup> ODT, in terms of tabletability and dissolution rate of Melatonin. Cop AA-MCC presented comparable hardness, lower dilution potential, higher lubricant sensitivity, lower ejection force, and faster Melatonin’s release time than Prosolv<sup>®</sup> ODT. In summary, Cop AA-MCC exhibited interesting physical, mechanical, and biopharmaceutical properties, which demonstrate its concurrence to commercially available co-processed excipients. Furthermore, the simplicity of its composition and the scalability of its elaboration makes this multifunctional excipient highly recommended for direct compression.
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spelling doaj.art-265e839b82bf48acb866661bfe42361c2023-11-21T11:43:21ZengMDPI AGPolymers2073-43602021-03-0113698810.3390/polym13060988Performance Evaluation of a Novel Biosourced Co-Processed Excipient in Direct Compression and Drug ReleaseRihab Benabbas0Noelia M. Sanchez-Ballester1Adrien Aubert2Tahmer Sharkawi3Bernard Bataille4Ian Soulairol5ICGM, University Montpellier, CNRS, ENSCM, 34090 Montpellier, FranceICGM, University Montpellier, CNRS, ENSCM, 34090 Montpellier, FranceICGM, University Montpellier, CNRS, ENSCM, 34090 Montpellier, FranceICGM, University Montpellier, CNRS, ENSCM, 34090 Montpellier, FranceICGM, University Montpellier, CNRS, ENSCM, 34090 Montpellier, FranceICGM, University Montpellier, CNRS, ENSCM, 34090 Montpellier, FranceThis study exposes the potential usefulness of a new co-processed excipient, composed of alginic acid and microcrystalline cellulose (Cop AA-MCC), for the preparation of immediate drug release tablets by direct compression. Evaluation of the physical and mechanical properties as well as the disintegration behavior of Cop AA-MCC in comparison to commercial co-processed excipients (Cellactose<sup>®</sup>, Ludipress<sup>®</sup>, Prosolv<sup>®</sup> SMCC HD90 and Prosolv<sup>®</sup> ODT) and to the physical mixture of the native excipients (MCC and AA), was carried out. The obtained results illustrate the good performance of Cop AA-MCC in terms of powder flowability, tablet tensile strength, compressibility, and disintegration time. Although, this new co-processed excipient showed a slightly high lubricant sensitivity, which was explained by its more plastic than fragmentary deformation behavior, it presented a low lubricant requirement due to the remarkably low ejection force observed during compression. Compression speed and dwell time seemed not to affect significantly the tabletability of Cop AA-MCC. The study exposed evenly the performance of Cop AA-MCC compared to Prosolv<sup>®</sup> ODT, in terms of tabletability and dissolution rate of Melatonin. Cop AA-MCC presented comparable hardness, lower dilution potential, higher lubricant sensitivity, lower ejection force, and faster Melatonin’s release time than Prosolv<sup>®</sup> ODT. In summary, Cop AA-MCC exhibited interesting physical, mechanical, and biopharmaceutical properties, which demonstrate its concurrence to commercially available co-processed excipients. Furthermore, the simplicity of its composition and the scalability of its elaboration makes this multifunctional excipient highly recommended for direct compression.https://www.mdpi.com/2073-4360/13/6/988co-processed excipientsdirect compressionalginic acidmelatonin
spellingShingle Rihab Benabbas
Noelia M. Sanchez-Ballester
Adrien Aubert
Tahmer Sharkawi
Bernard Bataille
Ian Soulairol
Performance Evaluation of a Novel Biosourced Co-Processed Excipient in Direct Compression and Drug Release
Polymers
co-processed excipients
direct compression
alginic acid
melatonin
title Performance Evaluation of a Novel Biosourced Co-Processed Excipient in Direct Compression and Drug Release
title_full Performance Evaluation of a Novel Biosourced Co-Processed Excipient in Direct Compression and Drug Release
title_fullStr Performance Evaluation of a Novel Biosourced Co-Processed Excipient in Direct Compression and Drug Release
title_full_unstemmed Performance Evaluation of a Novel Biosourced Co-Processed Excipient in Direct Compression and Drug Release
title_short Performance Evaluation of a Novel Biosourced Co-Processed Excipient in Direct Compression and Drug Release
title_sort performance evaluation of a novel biosourced co processed excipient in direct compression and drug release
topic co-processed excipients
direct compression
alginic acid
melatonin
url https://www.mdpi.com/2073-4360/13/6/988
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