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In Vitro–In Vivo Correlation for Desvenlafaxine Succinate Monohydrate Extended Release Tablets

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Abstract

The objective of this study was to develop a dissolution test in order to establish an in vitro–in vivo correlation (IVIVC) model for desvenlafaxine succinate monohydrate (DVSM) extended release (ER) tablets. The in vitro release characteristics of the drug were determined using USP apparatus 1 at 75 rpm, with volume of HCl pH 1.2, acetate buffer solution (ABS) pH 4.5, or phosphate buffer solution (PBS) pH 6.8. In vivo plasma concentrations and pharmacokinetic parameters in healthy volunteers were obtained from a bioequivalence study. The similarity factors f1 and f2 were used to compare the dissolution data. The IVIVC model was developed using fraction dissolved and fraction absorbed of the reference product. For predictability, the results showed that the percentage prediction error (%PE) value of Cmax was 7.63%. The observed low prediction error for Cmax demonstrated that the IVIVC model was valid for this parameter.

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Authors and Affiliations

  1. Department of Drugs and Pharmaceutics, Faculty of Pharmacy, Federal University of Rio de Janeiro, Av. Carlos Chagas Filho, 373, CCS, Bss, sl15, Rio de Janeiro, RJ, 21941-902, Brazil

    Jéssica Domingos da Silva, Valéria Pereira de Sousa & Lucio Mendes Cabral

  2. Programa de Pós-graduação Stricto Sensu em Ciências da Saúde, Universidade São Francisco, Av. São Francisco de Assis, 214, Bragança Paulista, SP, 12916-900, Brazil

    Marcelo Gomes Davanço, Patrícia de Oliveira Carvalho & Daniel Rossi Campos

  3. Faculty of Pharmaceutical Sciences, University of Campinas – UNICAMP, Campinas, São Paulo, Brazil

    Jessica Meulman

Authors
  1. Jéssica Domingos da Silva
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  2. Valéria Pereira de Sousa
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  3. Lucio Mendes Cabral
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  4. Marcelo Gomes Davanço
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  5. Jessica Meulman
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  6. Patrícia de Oliveira Carvalho
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  7. Daniel Rossi Campos
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Corresponding author

Correspondence to Valéria Pereira de Sousa.

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The study was carried out in a Brazilian Contract Research Organization and had the opinion of the ethics committee approved under No. 572.456

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da Silva, J.D., de Sousa, V.P., Cabral, L.M. et al. In Vitro–In Vivo Correlation for Desvenlafaxine Succinate Monohydrate Extended Release Tablets. AAPS PharmSciTech 21, 195 (2020). https://doi.org/10.1208/s12249-020-01740-x

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