Determination of Critical Parameters of Drug Substance Influencing Dissolution: A Case Study
The result's identifiers
Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216305%3A26310%2F14%3APU110449" target="_blank" >RIV/00216305:26310/14:PU110449 - isvavai.cz</a>
Result on the web
<a href="https://www.hindawi.com/journals/bmri/2014/929248/" target="_blank" >https://www.hindawi.com/journals/bmri/2014/929248/</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1155/2014/929248" target="_blank" >10.1155/2014/929248</a>
Alternative languages
Result language
angličtina
Original language name
Determination of Critical Parameters of Drug Substance Influencing Dissolution: A Case Study
Original language 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.
Czech name
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Czech description
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Classification
Type
J<sub>imp</sub> - Article in a specialist periodical, which is included in the Web of Science database
CEP classification
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OECD FORD branch
10403 - Physical chemistry
Result continuities
Project
<a href="/en/project/LO1211" target="_blank" >LO1211: Materials Research Centre at FCH BUT- Sustainability and Development</a><br>
Continuities
P - Projekt vyzkumu a vyvoje financovany z verejnych zdroju (s odkazem do CEP)<br>S - Specificky vyzkum na vysokych skolach
Others
Publication year
2014
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Data specific for result type
Name of the periodical
JOURNAL OF BIOMEDICINE AND BIOTECHNOLOGY
ISSN
1110-7243
e-ISSN
1110-7251
Volume of the periodical
2014
Issue of the periodical within the volume
1
Country of publishing house
US - UNITED STATES
Number of pages
9
Pages from-to
1-9
UT code for WoS article
000346287700001
EID of the result in the Scopus database
2-s2.0-84935858526