Details

Autor(en) / Beteiligte

• da Silva, Jéssica Domingos
• de Sousa, Valéria Pereira
• Cabral, Lucio Mendes
• Davanço, Marcelo Gomes
• Meulman, Jessica
• de Oliveira Carvalho, Patrícia
• Campos, Daniel Rossi

Titel

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

Ist Teil von

• AAPS PharmSciTech, 2020-07, Vol.21 (5), p.195-195, Article 195

Ort / Verlag

Cham: Springer International Publishing

Erscheinungsjahr

2020

Quelle

2022 ECC(Springer)

Beschreibungen/Notizen

• 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 f 1 and f 2 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 C max was 7.63%. The observed low prediction error for C max demonstrated that the IVIVC model was valid for this parameter.