Determination of inherent dissolution performance of drug substances

dc.contributor.authorSleziona, Dominik
dc.contributor.authorMattusch, Amelie
dc.contributor.authorSchaldach, Gerhard
dc.contributor.authorEly, David R.
dc.contributor.authorSadowski, Gabriele
dc.contributor.authorThommes, Markus
dc.date.accessioned2021-02-18T14:08:58Z
dc.date.available2021-02-18T14:08:58Z
dc.date.issued2021-01-22
dc.description.abstractThe dissolution behavior of novel active pharmaceutical ingredients (API) is a crucial parameter in drug formulation since it frequently affects the drug release. Generally, a distinction is made between surface-reaction- and diffusion-controlled drug release. Therefore, dissolution studies such as the intrinsic dissolution test defined in the pharmacopeia have been performed for many years. In order to overcome the disadvantages of the common intrinsic dissolution test, a new experimental setup was developed within this study. Specifically, a flow channel was designed and tested for measuring the mass transfer from a flat, solid surface dissolving into a fluid flowing over the surface with well-defined flow conditions. A mathematical model was developed that distinguishes between surface-reaction- and diffusion-limited drug release based on experimental data. Three different drugs—benzocaine, theophylline and griseofulvin—were used to investigate the mass flux during dissolution due to surface reaction, diffusion and convection kinetics. This new technique shows potential to be a valuable tool for the identification of formulation strategies.en
dc.identifier.urihttp://hdl.handle.net/2003/40033
dc.identifier.urihttp://dx.doi.org/10.17877/DE290R-21914
dc.language.isoende
dc.relation.ispartofseriesPharmaceutics;13(2)
dc.rights.urihttps://creativecommons.org/licenses/by/4.0/
dc.subjectDrug releaseen
dc.subjectFlow channelen
dc.subjectIntrinsic dissolutionen
dc.subjectSurface reactionen
dc.subjectTwo-film theoryen
dc.subject.ddc660
dc.titleDetermination of inherent dissolution performance of drug substancesen
dc.typeTextde
dc.type.publicationtypearticleen
dcterms.accessRightsopen access
eldorado.secondarypublicationtruede
eldorado.secondarypublication.primarycitationSleziona, D.; Mattusch, A.; Schaldach, G.; Ely, D.R.; Sadowski, G.; Thommes, M. Determination of Inherent Dissolution Performance of Drug Substances. Pharmaceutics 2021, 13, 146.de
eldorado.secondarypublication.primaryidentifierhttps://doi.org/10.3390/pharmaceutics13020146de

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