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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Bibliographic Details
Published in:BioMed research international 2014-01, Vol.2014 (2014), p.1-9
Main Authors: Jampilek, Josef, Vesely, Michal, Opravil, Tomas, Bartonickova, Eva, Parizek, Ladislav, Kalina, Michal, Bojnanska, Erika, Pekar, Miloslav
Format: Article
Language:English
Subjects:
Chemical Phenomena
Dissolution
Dissolution (Chemistry)
Drug dosages
Drug Liberation
Drugs
Manufacturing
Methods
Microscopy, Electron, Scanning
Particle Size
Pharmaceutical industry
Solubility
Studies
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Summary: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.
ISSN:2314-6133
2314-6141
DOI:10.1155/2014/929248