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Determination of Critical Parameters of Drug Substance Influencing Dissolution: A Case Study
The purpose of this study was to specify critical parameters (physicochemical characteristics) of drug substance that can affect dissolution profile/dissolution rate of the final drug product manufactured by validated procedure from various batches of the same drug substance received from different...
Autores principales: | , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Hindawi Publishing Corporation
2014
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4181942/ https://www.ncbi.nlm.nih.gov/pubmed/25317424 http://dx.doi.org/10.1155/2014/929248 |
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author | Bojnanska, Erika Kalina, Michal Parizek, Ladislav Bartonickova, Eva Opravil, Tomas Vesely, Michal Pekar, Miloslav Jampilek, Josef |
author_facet | Bojnanska, Erika Kalina, Michal Parizek, Ladislav Bartonickova, Eva Opravil, Tomas Vesely, Michal Pekar, Miloslav Jampilek, Josef |
author_sort | Bojnanska, Erika |
collection | PubMed |
description | The purpose of this study was to specify critical parameters (physicochemical characteristics) of drug substance that can affect dissolution profile/dissolution rate of the final drug product manufactured by validated procedure from various batches of the same drug substance received from different suppliers. The target was to design a sufficiently robust drug substance specification allowing to obtain a satisfactory drug product. For this reason, five batches of the drug substance and five samples of the final peroral drug products were analysed with the use of solid state analysis methods on the bulk level. Besides polymorphism, particle size distribution, surface area, zeta potential, and water content were identified as important parameters, and the zeta potential and the particle size distribution of the drug substance seem to be critical quality attributes affecting the dissolution rate of the drug substance released from the final peroral drug formulation. |
format | Online Article Text |
id | pubmed-4181942 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2014 |
publisher | Hindawi Publishing Corporation |
record_format | MEDLINE/PubMed |
spelling | pubmed-41819422014-10-14 Determination of Critical Parameters of Drug Substance Influencing Dissolution: A Case Study Bojnanska, Erika Kalina, Michal Parizek, Ladislav Bartonickova, Eva Opravil, Tomas Vesely, Michal Pekar, Miloslav Jampilek, Josef Biomed Res Int Research Article The purpose of this study was to specify critical parameters (physicochemical characteristics) of drug substance that can affect dissolution profile/dissolution rate of the final drug product manufactured by validated procedure from various batches of the same drug substance received from different suppliers. The target was to design a sufficiently robust drug substance specification allowing to obtain a satisfactory drug product. For this reason, five batches of the drug substance and five samples of the final peroral drug products were analysed with the use of solid state analysis methods on the bulk level. Besides polymorphism, particle size distribution, surface area, zeta potential, and water content were identified as important parameters, and the zeta potential and the particle size distribution of the drug substance seem to be critical quality attributes affecting the dissolution rate of the drug substance released from the final peroral drug formulation. Hindawi Publishing Corporation 2014 2014-09-15 /pmc/articles/PMC4181942/ /pubmed/25317424 http://dx.doi.org/10.1155/2014/929248 Text en Copyright © 2014 Erika Bojnanska et al. https://creativecommons.org/licenses/by/3.0/ This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Research Article Bojnanska, Erika Kalina, Michal Parizek, Ladislav Bartonickova, Eva Opravil, Tomas Vesely, Michal Pekar, Miloslav Jampilek, Josef Determination of Critical Parameters of Drug Substance Influencing Dissolution: A Case Study |
title | Determination of Critical Parameters of Drug Substance Influencing Dissolution: A Case Study |
title_full | Determination of Critical Parameters of Drug Substance Influencing Dissolution: A Case Study |
title_fullStr | Determination of Critical Parameters of Drug Substance Influencing Dissolution: A Case Study |
title_full_unstemmed | Determination of Critical Parameters of Drug Substance Influencing Dissolution: A Case Study |
title_short | Determination of Critical Parameters of Drug Substance Influencing Dissolution: A Case Study |
title_sort | determination of critical parameters of drug substance influencing dissolution: a case study |
topic | Research Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4181942/ https://www.ncbi.nlm.nih.gov/pubmed/25317424 http://dx.doi.org/10.1155/2014/929248 |
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