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dc.date.accessioned 2010-09-27T14:42:21Z
dc.date.available 2010-09-27T03:00:00Z
dc.date.issued 2010 es
dc.identifier.uri http://hdl.handle.net/10915/8022
dc.description.abstract A predictive in vitro-invivo correlation (IVIVC) can empower in vitro dissolution as a surrogate for in vivo bioavailability / bioequivalence. IVIVCs can decrease regulatory burden by decreasing the number of biostudies required in support of a drug product. The present study concerns the establishment of in vitro-in vivo correlation for three different sustained release nimesulide loaded ethylcellulose microparticulate formulations (M1, M2 and M3) and conventional tablet (100 mg Nimaran®-Novartis, Pakistan). In vitro dissolution study was conducted in phosphate buffer pH 6.8 stirred at 50 rpm and 37 ± 0.5ºC. A validated HPLC method was adopted to conduct bioavailability studies in young healthy human volunteers. Ultimately IVIVC of prepared microparticles and conventional tablet was established using Wagner-Nelson method. M1 and M2 formulations and Nimaran® exhibited good linear IVIVC (R2 = 0.9220, 0.9124, 0.8728, respectively) as compared to M3 (R2 = 0.9449). The results substantiate the success of this mathematical simulation study encourage researchers to conduct biowaiver studies for other BCS class II drugs. es
dc.format.extent p. 1029-1034 es
dc.language en es
dc.title Development of in vitro-in vivo correlation for nimesulide loaded ethylcellulose microparticles es
dc.type Articulo es
sedici.identifier.uri http://www.latamjpharm.org/resumenes/29/6/LAJOP_29_6_2_7.pdf es
sedici.creator.person Khan, Shujaat A. es
sedici.creator.person Ahmad, Mahmood es
sedici.creator.person Shoaib, Harris M. es
sedici.creator.person Murtaza, Ghulam es
sedici.creator.person Aamir, Muhammad N. es
sedici.creator.person Kousar, Rozina es
sedici.creator.person Rasool, Fatima es
sedici.creator.person Madni, Asadullah es
sedici.subject.materias Farmacia es
sedici.subject.descriptores Farmacología es
sedici.subject.descriptores Disolución es
sedici.subject.descriptores Biodisponibilidad es
sedici.subject.descriptores Medicamentos es
sedici.subject.descriptores Agentes antiinflamatorios es
sedici.subject.keyword dissolution studies; bioavailability; internal prediction error; IVIVC; nimesulide es
sedici.description.fulltext false es
mods.originInfo.place Colegio de Farmacéuticos de la Provincia de Buenos Aires es
sedici.subtype Comunicacion es
sedici2003.identifier ARG-FARM-ART-0000001509 es
sedici.relation.journalTitle Latin American Journal of Pharmacy es
sedici.relation.journalVolumeAndIssue vol. 29, no. 6 es


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