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Development Strategies for Herbal Products Reducing the Influence of Natural Variance in Dry Mass on Tableting Properties and Tablet Characteristics
One “Quality by Design” approach is the focus on the variability of the properties of the active substance. This is crucially important for active substances that are obtained from natural resources such as herbal plant material and extracts. In this paper, we present various strategies for the deve...
Autores principales: | , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
MDPI
2012
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3834931/ https://www.ncbi.nlm.nih.gov/pubmed/24300367 http://dx.doi.org/10.3390/pharmaceutics4040501 |
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author | Qusaj, Ylber Leng, Andreas Alshihabi, Firas Krasniqi, Blerim Vandamme, Thierry |
author_facet | Qusaj, Ylber Leng, Andreas Alshihabi, Firas Krasniqi, Blerim Vandamme, Thierry |
author_sort | Qusaj, Ylber |
collection | PubMed |
description | One “Quality by Design” approach is the focus on the variability of the properties of the active substance. This is crucially important for active substances that are obtained from natural resources such as herbal plant material and extracts. In this paper, we present various strategies for the development of herbal products especially taking into account the natural batch-to-batch variability (mainly of the dry mass) of tablets that contain a fixed amount of tincture. The following steps in the development have been evaluated for the outcome of the physico-chemical properties of the resulting tablets and intermediates: concentration of the tincture extracted from Echinacea fresh plant, loading of the concentrate onto an inert carrier, the respective wet granulation and drying step, including milling, and the adjuvant excipients for the tablet compression step. The responses that were investigated are the mean particle size of the dried and milled granulates, compaction properties and disintegration time of the tablets. Increased particle size showed a significant increase of the disintegration time and a decrease of the compaction properties. In addition, our results showed that the particle size has a great dependency on the ratio of liquid to carrier during the wet granulation process. Thus, the variability of the respective parameters tested was influenced by the performed strategies, which is how the tincture correlated to its dry mass and the relation of the amount of carrier used. In order to optimize these parameters, a strategy considering the above-mentioned points has to be chosen. |
format | Online Article Text |
id | pubmed-3834931 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2012 |
publisher | MDPI |
record_format | MEDLINE/PubMed |
spelling | pubmed-38349312013-11-21 Development Strategies for Herbal Products Reducing the Influence of Natural Variance in Dry Mass on Tableting Properties and Tablet Characteristics Qusaj, Ylber Leng, Andreas Alshihabi, Firas Krasniqi, Blerim Vandamme, Thierry Pharmaceutics Communication One “Quality by Design” approach is the focus on the variability of the properties of the active substance. This is crucially important for active substances that are obtained from natural resources such as herbal plant material and extracts. In this paper, we present various strategies for the development of herbal products especially taking into account the natural batch-to-batch variability (mainly of the dry mass) of tablets that contain a fixed amount of tincture. The following steps in the development have been evaluated for the outcome of the physico-chemical properties of the resulting tablets and intermediates: concentration of the tincture extracted from Echinacea fresh plant, loading of the concentrate onto an inert carrier, the respective wet granulation and drying step, including milling, and the adjuvant excipients for the tablet compression step. The responses that were investigated are the mean particle size of the dried and milled granulates, compaction properties and disintegration time of the tablets. Increased particle size showed a significant increase of the disintegration time and a decrease of the compaction properties. In addition, our results showed that the particle size has a great dependency on the ratio of liquid to carrier during the wet granulation process. Thus, the variability of the respective parameters tested was influenced by the performed strategies, which is how the tincture correlated to its dry mass and the relation of the amount of carrier used. In order to optimize these parameters, a strategy considering the above-mentioned points has to be chosen. MDPI 2012-10-08 /pmc/articles/PMC3834931/ /pubmed/24300367 http://dx.doi.org/10.3390/pharmaceutics4040501 Text en © 2012 by the authors; licensee MDPI, Basel, Switzerland. http://creativecommons.org/licenses/by/3.0/ This article is an open-access article distributed under the terms and conditions of the Creative Commons Attribution license (http://creativecommons.org/licenses/by/3.0/). |
spellingShingle | Communication Qusaj, Ylber Leng, Andreas Alshihabi, Firas Krasniqi, Blerim Vandamme, Thierry Development Strategies for Herbal Products Reducing the Influence of Natural Variance in Dry Mass on Tableting Properties and Tablet Characteristics |
title | Development Strategies for Herbal Products Reducing the Influence of Natural Variance in Dry Mass on Tableting Properties and Tablet Characteristics |
title_full | Development Strategies for Herbal Products Reducing the Influence of Natural Variance in Dry Mass on Tableting Properties and Tablet Characteristics |
title_fullStr | Development Strategies for Herbal Products Reducing the Influence of Natural Variance in Dry Mass on Tableting Properties and Tablet Characteristics |
title_full_unstemmed | Development Strategies for Herbal Products Reducing the Influence of Natural Variance in Dry Mass on Tableting Properties and Tablet Characteristics |
title_short | Development Strategies for Herbal Products Reducing the Influence of Natural Variance in Dry Mass on Tableting Properties and Tablet Characteristics |
title_sort | development strategies for herbal products reducing the influence of natural variance in dry mass on tableting properties and tablet characteristics |
topic | Communication |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3834931/ https://www.ncbi.nlm.nih.gov/pubmed/24300367 http://dx.doi.org/10.3390/pharmaceutics4040501 |
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