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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...

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Autores principales: Bojnanska, Erika, Kalina, Michal, Parizek, Ladislav, Bartonickova, Eva, Opravil, Tomas, Vesely, Michal, Pekar, Miloslav, Jampilek, Josef
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Hindawi Publishing Corporation 2014
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.
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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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