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Comparative Evaluation of the Powder and Tableting Properties of Regular and Direct Compression Hypromellose from Different Vendors

Hypromellose, a widely used polymer in the pharmaceutical industry, is available in several grades, depending on the percentage of substitution of the methoxyl and hydroxypropyl groups and molecular weight, and in various functional forms (e.g., suitable for direct compression tableting). These diff...

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Autores principales: Mawla, Nihad, Alshafiee, Maen, Gamble, John, Tobyn, Mike, Liu, Lande, Walton, Karl, Conway, Barbara R., Timmins, Peter, Asare-Addo, Kofi
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10459357/
https://www.ncbi.nlm.nih.gov/pubmed/37631368
http://dx.doi.org/10.3390/pharmaceutics15082154
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author Mawla, Nihad
Alshafiee, Maen
Gamble, John
Tobyn, Mike
Liu, Lande
Walton, Karl
Conway, Barbara R.
Timmins, Peter
Asare-Addo, Kofi
author_facet Mawla, Nihad
Alshafiee, Maen
Gamble, John
Tobyn, Mike
Liu, Lande
Walton, Karl
Conway, Barbara R.
Timmins, Peter
Asare-Addo, Kofi
author_sort Mawla, Nihad
collection PubMed
description Hypromellose, a widely used polymer in the pharmaceutical industry, is available in several grades, depending on the percentage of substitution of the methoxyl and hydroxypropyl groups and molecular weight, and in various functional forms (e.g., suitable for direct compression tableting). These differences can affect their physicomechanical properties, and so this study aims to characterise the particle size and mechanical properties of HPMC K100M polymer grades from four different vendors. Eight polymers (CR and DC grades) were analysed using scanning electron microscopy (SEM) and light microscopy automated image analysis particle characterisation to examine the powder’s particle morphology and particle size distribution. Bulk density, tapped density, and true density of the materials were also analysed. Flow was determined using a shear cell tester. Flat-faced polymer compacts were made at five different compression forces and the mechanical properties of the compacts were evaluated to give an indication of the powder’s capacity to form a tablet with desirable strength under specific pressures. The results indicated that the CR grades of the polymers displayed a smaller particle size and better mechanical properties compared to the DC grade HPMC K100M polymers. The DC grades, however, had better flow properties than their CR counterparts. The results also suggested some similarities and differences between some of the polymers from the different vendors despite the similarity in substitution level, reminding the user that care and consideration should be given when substitution is required.
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spelling pubmed-104593572023-08-27 Comparative Evaluation of the Powder and Tableting Properties of Regular and Direct Compression Hypromellose from Different Vendors Mawla, Nihad Alshafiee, Maen Gamble, John Tobyn, Mike Liu, Lande Walton, Karl Conway, Barbara R. Timmins, Peter Asare-Addo, Kofi Pharmaceutics Article Hypromellose, a widely used polymer in the pharmaceutical industry, is available in several grades, depending on the percentage of substitution of the methoxyl and hydroxypropyl groups and molecular weight, and in various functional forms (e.g., suitable for direct compression tableting). These differences can affect their physicomechanical properties, and so this study aims to characterise the particle size and mechanical properties of HPMC K100M polymer grades from four different vendors. Eight polymers (CR and DC grades) were analysed using scanning electron microscopy (SEM) and light microscopy automated image analysis particle characterisation to examine the powder’s particle morphology and particle size distribution. Bulk density, tapped density, and true density of the materials were also analysed. Flow was determined using a shear cell tester. Flat-faced polymer compacts were made at five different compression forces and the mechanical properties of the compacts were evaluated to give an indication of the powder’s capacity to form a tablet with desirable strength under specific pressures. The results indicated that the CR grades of the polymers displayed a smaller particle size and better mechanical properties compared to the DC grade HPMC K100M polymers. The DC grades, however, had better flow properties than their CR counterparts. The results also suggested some similarities and differences between some of the polymers from the different vendors despite the similarity in substitution level, reminding the user that care and consideration should be given when substitution is required. MDPI 2023-08-17 /pmc/articles/PMC10459357/ /pubmed/37631368 http://dx.doi.org/10.3390/pharmaceutics15082154 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
Mawla, Nihad
Alshafiee, Maen
Gamble, John
Tobyn, Mike
Liu, Lande
Walton, Karl
Conway, Barbara R.
Timmins, Peter
Asare-Addo, Kofi
Comparative Evaluation of the Powder and Tableting Properties of Regular and Direct Compression Hypromellose from Different Vendors
title Comparative Evaluation of the Powder and Tableting Properties of Regular and Direct Compression Hypromellose from Different Vendors
title_full Comparative Evaluation of the Powder and Tableting Properties of Regular and Direct Compression Hypromellose from Different Vendors
title_fullStr Comparative Evaluation of the Powder and Tableting Properties of Regular and Direct Compression Hypromellose from Different Vendors
title_full_unstemmed Comparative Evaluation of the Powder and Tableting Properties of Regular and Direct Compression Hypromellose from Different Vendors
title_short Comparative Evaluation of the Powder and Tableting Properties of Regular and Direct Compression Hypromellose from Different Vendors
title_sort comparative evaluation of the powder and tableting properties of regular and direct compression hypromellose from different vendors
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10459357/
https://www.ncbi.nlm.nih.gov/pubmed/37631368
http://dx.doi.org/10.3390/pharmaceutics15082154
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