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Determination of Critical Parameters of Drug Substance Influencing Dissolution: A Case Study
Joint Authors
Bojnanska, Erika
Kalina, Michal
Parizek, Ladislav
Bartonickova, Eva
Opravil, Tomas
Vesely, Michal
Pekar, Miloslav
Jampilek, Josef
Source
Issue
Vol. 2014, Issue 2014 (31 Dec. 2014), pp.1-9, 9 p.
Publisher
Hindawi Publishing Corporation
Publication Date
2014-09-15
Country of Publication
Egypt
No. of Pages
9
Main Subjects
Abstract EN
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.
American Psychological Association (APA)
Bojnanska, Erika& Kalina, Michal& Parizek, Ladislav& Bartonickova, Eva& Opravil, Tomas& Vesely, Michal…[et al.]. 2014. Determination of Critical Parameters of Drug Substance Influencing Dissolution: A Case Study. BioMed Research International،Vol. 2014, no. 2014, pp.1-9.
https://search.emarefa.net/detail/BIM-1034605
Modern Language Association (MLA)
Bojnanska, Erika…[et al.]. Determination of Critical Parameters of Drug Substance Influencing Dissolution: A Case Study. BioMed Research International No. 2014 (2014), pp.1-9.
https://search.emarefa.net/detail/BIM-1034605
American Medical Association (AMA)
Bojnanska, Erika& Kalina, Michal& Parizek, Ladislav& Bartonickova, Eva& Opravil, Tomas& Vesely, Michal…[et al.]. Determination of Critical Parameters of Drug Substance Influencing Dissolution: A Case Study. BioMed Research International. 2014. Vol. 2014, no. 2014, pp.1-9.
https://search.emarefa.net/detail/BIM-1034605
Data Type
Journal Articles
Language
English
Notes
Includes bibliographical references
Record ID
BIM-1034605