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Evaluation of pantoprazole formulations in different dissolution apparatus using biorelevant medium.
de Campos, Daniel Rossi; Klein, Sandra; Zoller, Thomas; Vieria, Nelson Rogério; Barros, Fábio Alessandro Proença; Meurer, Eduardo César; Coelho, Edvaldo Capobiango; Marchioretto, Marco Antônio; Pedrazzoli, José.
Afiliación
  • de Campos DR; Clinical Pharmacology and Gastroenterology Unit, São Francisco University Medical School, Braganga Paulista, SP, Brazil. cinetica04@yahoo.com.br
Arzneimittelforschung ; 60(1): 42-7, 2010.
Article en En | MEDLINE | ID: mdl-20184226
ABSTRACT

PURPOSE:

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 (f2) 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 f2 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.
Asunto(s)
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Colección: 01-internacional Base de datos: MEDLINE Asunto principal: 2-Piridinilmetilsulfinilbencimidazoles / Inhibidores de la Bomba de Protones Tipo de estudio: Observational_studies / Prognostic_studies / Risk_factors_studies Límite: Humans Idioma: En Revista: Arzneimittelforschung Año: 2010 Tipo del documento: Article País de afiliación: Brasil
Buscar en Google
Colección: 01-internacional Base de datos: MEDLINE Asunto principal: 2-Piridinilmetilsulfinilbencimidazoles / Inhibidores de la Bomba de Protones Tipo de estudio: Observational_studies / Prognostic_studies / Risk_factors_studies Límite: Humans Idioma: En Revista: Arzneimittelforschung Año: 2010 Tipo del documento: Article País de afiliación: Brasil