About: Determination of Critical Parameters of Drug Substance Influencing Dissolution: A Case Study

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rdf:type	skos:Concept http://linked.opendata.cz/ontology/domain/vavai/Vysledek
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. 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. (en)
Title	Determination of Critical Parameters of Drug Substance Influencing Dissolution: A Case Study Determination of Critical Parameters of Drug Substance Influencing Dissolution: A Case Study (en)
skos:prefLabel	Determination of Critical Parameters of Drug Substance Influencing Dissolution: A Case Study Determination of Critical Parameters of Drug Substance Influencing Dissolution: A Case Study (en)
skos:notation	RIV/00216305:26310/14:PU110449!RIV15-MSM-26310___
http://linked.open...avai/riv/aktivita	P S
http://linked.open...avai/riv/aktivity	P(LO1211), S
http://linked.open...iv/cisloPeriodika	1
http://linked.open...vai/riv/dodaniDat	2015
http://linked.open...aciTvurceVysledku	Bartoníčková, Eva Kalina, Michal Veselý, Michal Pekař, Miloslav Opravil, Tomáš Pařízek, Ladislav
http://linked.open.../riv/druhVysledku	J - Článek v odborném periodiku
http://linked.open...iv/duvernostUdaju	S - Úplné a pravdivé údaje nepodléhající ochraně podle zvláštních právních předpisů
http://linked.open...titaPredkladatele	Vysoké učení technické v Brně / Fakulta chemická
http://linked.open...dnocenehoVysledku	10749
http://linked.open...ai/riv/idVysledku	RIV/00216305:26310/14:PU110449
http://linked.open...riv/jazykVysledku	eng - angličtina
http://linked.open.../riv/klicovaSlova	Critical Quality Attributes, Active Pharmaceutical Ingredient, Dissolution testing, Zeta potential, Particle size distribution, Specific surface area, Scanning electron microscopy (en)
http://linked.open.../riv/klicoveSlovo	Particle size distribution Zeta potential Scanning electron microscopy Active Pharmaceutical Ingredient Critical Quality Attributes Dissolution testing Specific surface area
http://linked.open...odStatuVydavatele	US - Spojené státy americké
http://linked.open...ontrolniKodProRIV	[B55D915B6736]
http://linked.open...i/riv/nazevZdroje	JOURNAL OF BIOMEDICINE AND BIOTECHNOLOGY
http://linked.open...in/vavai/riv/obor	CF
http://linked.open...ichTvurcuVysledku	6 (xsd:int)
http://linked.open...cetTvurcuVysledku	8 (xsd:int)
http://linked.open...vavai/riv/projekt	Materials Research Centre at FCH BUT- Sustainability and Development
http://linked.open...UplatneniVysledku	2014
http://linked.open...v/svazekPeriodika	2014
http://linked.open...iv/tvurceVysledku	Jampílek, Josef Kalina, Michal Pekař, Miloslav Veselý, Michal Opravil, Tomáš Bartoníčková, Eva Bojňanská, Erika Pařízek, Ladislav
issn	1110-7243
number of pages	9 (xsd:int)
http://localhost/t...ganizacniJednotka	26310

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