Publication result detail
Determination of Critical Parameters of Drug Substance Influencing Dissolution: A Case Study
BOJŇANSKÁ, E.; KALINA, M.; PAŘÍZEK, L.; BARTONÍČKOVÁ, E.; OPRAVIL, T.; VESELÝ, M.; PEKAŘ, M.; JAMPÍLEK, J.
Original Title
Determination of Critical Parameters of Drug Substance Influencing Dissolution: A Case Study
English Title
Determination of Critical Parameters of Drug Substance Influencing Dissolution: A Case Study
Type
WoS Article
Original Abstract
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.
English abstract
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.
Keywords
Critical Quality Attributes; Active Pharmaceutical Ingredient; Dissolution testing, Zeta potential; Particle size distribution; Specific surface area; Scanning electron microscopy
Key words in English
Critical Quality Attributes; Active Pharmaceutical Ingredient; Dissolution testing, Zeta potential; Particle size distribution; Specific surface area; Scanning electron microscopy
Authors
BOJŇANSKÁ, E.; KALINA, M.; PAŘÍZEK, L.; BARTONÍČKOVÁ, E.; OPRAVIL, T.; VESELÝ, M.; PEKAŘ, M.; JAMPÍLEK, J.
RIV year
2017
Released
15.09.2014
Publisher
Hindawi Publishing Corporation
Location
New York, USA
ISBN
1110-7243
Periodical
JOURNAL OF BIOMEDICINE AND BIOTECHNOLOGY
Volume
2014
Number
1
State
United States of America
Pages from
1
Pages to
9
Pages count
9
URL
Full text in the Digital Library
BibTex
@article{BUT109417,
author="Erika {Bojňanská} and Michal {Kalina} and Ladislav {Pařízek} and Eva {Bartoníčková} and Tomáš {Opravil} and Michal {Veselý} and Miloslav {Pekař} and Josef {Jampílek}",
title="Determination of Critical Parameters of Drug Substance Influencing Dissolution: A Case Study",
journal="JOURNAL OF BIOMEDICINE AND BIOTECHNOLOGY",
year="2014",
volume="2014",
number="1",
pages="1--9",
doi="10.1155/2014/929248",
issn="1110-7243",
url="http://dx.doi.org/10.1155/2014/929248"
}Documents