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dc.creatorBukara, Katarina
dc.creatorSchueller, Laurent
dc.creatorRosier, Jan
dc.creatorDaems, Tinne
dc.creatorVerheyden, Loes
dc.creatorEelen, Siemon
dc.creatorMartens, Johan A.
dc.creatorVan den Mooter, Guy
dc.creatorBugarski, Branko
dc.creatorKiekens, Filip
dc.date.accessioned2021-03-10T13:01:16Z
dc.date.available2021-03-10T13:01:16Z
dc.date.issued2016
dc.identifier.issn0022-3549
dc.identifier.urihttp://TechnoRep.tmf.bg.ac.rs/handle/123456789/3240
dc.description.abstractThe present study aims to evaluate the in vitro and in vivo performance of ordered mesoporous silica (OMS) as a carrier for the poorly water-soluble compound fenofibrate. Fenofibrate was loaded into OMS via incipient wetness impregnation to obtain a 29% drug load and formulated into capsules. Two capsule dosage forms (containing 33.5 and 16.75 mg fenofibrate, respectively) were compared with the commercially available forms-Lipanthyl (R) (fenofibrate microcrystals) and Tricor (R) (fenofibrate nanocrystals). In vitro dissolution tests showed that the amount of fenofibrate released from Lipanthyl (R) and Tricor (R) was approximately 30%, whereas approximately 66% and 60% of the drug was released from OMS capsules containing 33.5 and 16.75 mg of fenofibrate, respectively. Storage of OMS capsules loaded with 33.5 mg of fenofibrate at 25 degrees C/60% relative humidity (RH) or 40 degrees C/75% RH did not alter the release kinetics, nor the physical state of the compound, pointing the stability of the present formulation. The in vivo study in dogs confirmed satisfying level of safety and tolerability of fenofibrate-OMS formulation (eq. 33.5 mg) with the potential to improve the absorption of fenofibrate. Though some variability in the data, this formulation is promising to be further investigated in a clinical trial setting.en
dc.publisherWiley-Blackwell, Hoboken
dc.relationFormac Pharmaceuticals NV, Gaston Geenslaan, Leuven, Belgium
dc.rightsopenAccess
dc.sourceJournal of Pharmaceutical Sciences
dc.subjectordered mesoporous silicaen
dc.subjectfenofibrateen
dc.subjectpoor solubilityen
dc.subjectdissolutionen
dc.subjectoral bioavailabilityen
dc.titleIn Vivo Performance of Fenofibrate Formulated With Ordered Mesoporous Silica Versus 2-Marketed Formulations: A Comparative Bioavailability Study in Beagle Dogsen
dc.typearticle
dc.rights.licenseARR
dc.citation.epage2385
dc.citation.issue8
dc.citation.other105(8): 2381-2385
dc.citation.rankM22
dc.citation.spage2381
dc.citation.volume105
dc.identifier.doi10.1016/j.xphs.2016.05.019
dc.identifier.fulltexthttp://TechnoRep.tmf.bg.ac.rs/bitstream/id/1182/3237.pdf
dc.identifier.pmid27364460
dc.identifier.rcubconv_5076
dc.identifier.scopus2-s2.0-84979041804
dc.identifier.wos000381770400017
dc.type.versionpublishedVersion


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