Evaluation of pantoprazole formulations in different dissolution apparatus using biorelevant medium

dc.creatorde Campos, DR
dc.creatorKlein, S
dc.creatorZoller, T
dc.creatorVieria, NR
dc.creatorBarros, FAP
dc.creatorMeurer, EC
dc.creatorCoelho, EC
dc.creatorMarchioretto, MA
dc.creatorPedrazzoli, J
dc.date2010
dc.date2014-07-30T17:28:06Z
dc.date2015-11-26T17:40:42Z
dc.date2014-07-30T17:28:06Z
dc.date2015-11-26T17:40:42Z
dc.date.accessioned2018-03-29T00:22:25Z
dc.date.available2018-03-29T00:22:25Z
dc.identifierArzneimittel-forschung-drug Research. Ecv-editio Cantor Verlag Medizin Naturwissenschaften, v. 60, n. 1, n. 42, n. 47, 2010.
dc.identifier0004-4172
dc.identifierWOS:000274803500006
dc.identifierhttp://www.repositorio.unicamp.br/jspui/handle/REPOSIP/65877
dc.identifierhttp://repositorio.unicamp.br/jspui/handle/REPOSIP/65877
dc.identifier.urihttp://repositorioslatinoamericanos.uchile.cl/handle/2250/1286800
dc.descriptionPurpose. The study was developed to compare the in vitro dissolution profiles of pantoprazole (CAS 102625-70-7) formulations in both The United States Pharmacopeia (USP) apparatus 2 and 3 by applying biorelevant medium. Moreover, an in vitro-in vivo relationship was proposed considering in vivo data from a previously published study. Methods: In vitro dissolution profiles were evaluated in biorelevant medium in USP apparatus 2 and 3 and the dissolution curves were either compared by the similarity factor (f(2)) or a model-independent approach. The fraction of drug dissolved in vitro in apparatus 2 was compared with the fraction of drug absorbed in vivo, which was obtained from a retrospective in vivo study. An in vitro-in vivo relationship analysis was then applied to elucidate the overall absorption characteristics of formulations. Results: The dissolution profiles of formulations demonstrated similar disposition in biorelevant medium in both USP apparatus 2 and 3. The dissolution profiles were described by f(2) model in apparatus 2 and Weibull's function in apparatus 3. The vitro-in vivo relationship analysis showed that the formulations exhibited permeability rate-limiting absorption. Conclusion: Biorelevant medium in both USP apparatus 2 and 3 may be used as a tool to predict in vivo disposition of formulations of pantoprazole. Furthermore, it can be argued that biowaiver can be granted for enteric coated formulations of pantoprazole on the basis of in vitro dissolution profile.
dc.description60
dc.description1
dc.description42
dc.description47
dc.descriptionMedley S/A Industria Farmaceutica, Campinas, SP (Brazil)
dc.languageen
dc.publisherEcv-editio Cantor Verlag Medizin Naturwissenschaften
dc.publisherAulendorf
dc.publisherAlemanha
dc.relationArzneimittel-forschung-drug Research
dc.relationArzneimittelforschung
dc.rightsaberto
dc.sourceWeb of Science
dc.subjectBiopharmaceutics classification system
dc.subjectBiorelevant dissolution testing
dc.subjectCAS 102625-70-7
dc.subjectIn vitro-in vivo correlation
dc.subjectPantoprazole
dc.subjectBiopharmaceutics Classification-system
dc.subjectOral Dosage Forms
dc.subjectIn-vivo Relationships
dc.subjectBiowaiver Monographs
dc.subjectRelease
dc.subjectDrugs
dc.subjectBcs
dc.subjectHydrochloride
dc.subjectPerformance
dc.subjectCimetidine
dc.titleEvaluation of pantoprazole formulations in different dissolution apparatus using biorelevant medium
dc.typeArtículos de revistas


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