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Evaluation of pantoprazole formulations in different dissolution apparatus using biorelevant medium.
Arzneimittelforschung. 2010; 60(1):42-7.A

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.

Authors+Show Affiliations

Clinical Pharmacology and Gastroenterology Unit, São Francisco University Medical School, Braganga Paulista, SP, Brazil. cinetica04@yahoo.com.brNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

20184226

Citation

de Campos, Daniel Rossi, et al. "Evaluation of Pantoprazole Formulations in Different Dissolution Apparatus Using Biorelevant Medium." Arzneimittel-Forschung, vol. 60, no. 1, 2010, pp. 42-7.
de Campos DR, Klein S, Zoller T, et al. Evaluation of pantoprazole formulations in different dissolution apparatus using biorelevant medium. Arzneimittelforschung. 2010;60(1):42-7.
de Campos, D. R., Klein, S., Zoller, T., Vieria, N. R., Barros, F. A., Meurer, E. C., Coelho, E. C., Marchioretto, M. A., & Pedrazzoli, J. (2010). Evaluation of pantoprazole formulations in different dissolution apparatus using biorelevant medium. Arzneimittel-Forschung, 60(1), 42-7.
de Campos DR, et al. Evaluation of Pantoprazole Formulations in Different Dissolution Apparatus Using Biorelevant Medium. Arzneimittelforschung. 2010;60(1):42-7. PubMed PMID: 20184226.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Evaluation of pantoprazole formulations in different dissolution apparatus using biorelevant medium. AU - de Campos,Daniel Rossi, AU - Klein,Sandra, AU - Zoller,Thomas, AU - Vieria,Nelson Rogério, AU - Barros,Fábio Alessandro Proença, AU - Meurer,Eduardo César, AU - Coelho,Edvaldo Capobiango, AU - Marchioretto,Marco Antônio, AU - Pedrazzoli,José, PY - 2010/2/27/entrez PY - 2010/2/27/pubmed PY - 2010/3/23/medline SP - 42 EP - 7 JF - Arzneimittel-Forschung JO - Arzneimittelforschung VL - 60 IS - 1 N2 - 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. SN - 0004-4172 UR - https://www.unboundmedicine.com/medline/citation/20184226/Evaluation_of_pantoprazole_formulations_in_different_dissolution_apparatus_using_biorelevant_medium_ DB - PRIME DP - Unbound Medicine ER -