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

Loading...
Thumbnail Image
Date
2014-09-15
ORCID
Advisor
Referee
Mark
Journal Title
Journal ISSN
Volume Title
Publisher
Hindawi Publishing Corporation
Altmetrics
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.
Hlavním předmětem zájmu článu je nalézt a specifikovat kritické parametry (fyzikálně-chemického charakteru) studovaných složek léčiva, které mohou ovlivnit rozpustnost finálního produktu. Pro tyto účely byly charakterizovány vzorky na základě polymorfismu, distribuce velikosti částic, specifického povrchu, zeta potenciálu a obsahu vody. Velikost částic a zeta potenciál se zdají být hlavními atributy ovlivňujícími rozpustnost sledovaných složek léčiv i finálního produktu.
Description
Citation
JOURNAL OF BIOMEDICINE AND BIOTECHNOLOGY. 2014, vol. 2014, issue 1, p. 1-9.
http://dx.doi.org/10.1155/2014/929248
Document type
Peer-reviewed
Document version
Published version
Date of access to the full text
Language of document
en
Study field
Comittee
Date of acceptance
Defence
Result of defence
Document licence
Creative Commons Attribution 3.0 Unported
http://creativecommons.org/licenses/by/3.0/
Citace PRO