Theophylline granule formulation prepared by the wet granulation method: Comparison of in vitro dissolution profiles and estimation of in vivo plasma concentrations

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dc.contributor.authorKarasulu E.
dc.contributor.authorApaydin Ş.
dc.contributor.authorInce I.
dc.contributor.authorTuglular I.
dc.date.accessioned2019-10-27T00:09:49Z
dc.date.available2019-10-27T00:09:49Z
dc.date.issued2006
dc.departmentEge Üniversitesien_US
dc.description.abstractThe primary and secondary objectives of this study were to develop and evaluate the predictability of in vitro-in vivo correlation models for theophylline sustained release (SR) granules. Theophylline SR granules meeting the USP Drug Release Test criteria were prepared using ethyl cellulose (EC) and/or stearyl alcohol (SA) and the wet granulation method. In vitro dissolution studies of granule formulation were performed, and a commercial dosage form was prepared using USP XXIII apparatus II at pH 4.5. Differences and similarities between in vitro dissolution curves were compared using both model-dependent (t-test) and - independent (f 1 , f 2 test) statistical techniques, and it was shown that the three dissolution profiles i.e model-dependent, model-independent, and methods based on ANOVA were very similar. The in vivo performance of the commercial dosage form was tested by oral route using male rabbits and in vitro-in vivo correlations were established. This study indicates that the dosage forms with similar in vitro dissolution profiles may have a similar in vivo performance, and that this performance could be estimated using appropriate correlation equations.en_US
dc.identifier.doi10.1007/BF03190470en_US
dc.identifier.endpage298en_US
dc.identifier.issn0378-7966
dc.identifier.issue4en_US
dc.identifier.pmid17315541en_US
dc.identifier.scopusqualityN/Aen_US
dc.identifier.startpage291en_US
dc.identifier.urihttps://doi.org/10.1007/BF03190470
dc.identifier.urihttps://hdl.handle.net/11454/21795
dc.identifier.volume31en_US
dc.indekslendigikaynakScopusen_US
dc.indekslendigikaynakPubMeden_US
dc.language.isoenen_US
dc.publisherEditions Medecine et Hygieneen_US
dc.relation.ispartofEuropean Journal of Drug Metabolism and Pharmacokineticsen_US
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanıen_US
dc.rightsinfo:eu-repo/semantics/closedAccessen_US
dc.subjectEstimationen_US
dc.subjectGranulesen_US
dc.subjectIn vitro-in vivo correlationen_US
dc.subjectSimilarityen_US
dc.subjectSustained releaseen_US
dc.subjectTheophyllineen_US
dc.titleTheophylline granule formulation prepared by the wet granulation method: Comparison of in vitro dissolution profiles and estimation of in vivo plasma concentrationsen_US
dc.typeArticleen_US

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