We found a match
Your institution may have access to this item. Find your institution then sign in to continue.
- Title
In Vitro–In Vivo Correlation for Desvenlafaxine Succinate Monohydrate Extended Release Tablets.
- Authors
da Silva, Jéssica Domingos; de Sousa, Valéria Pereira; Cabral, Lucio Mendes; Davanço, Marcelo Gomes; Meulman, Jessica; de Oliveira Carvalho, Patrícia; Campos, Daniel Rossi
- 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.
- Publication
AAPS PharmSciTech, 2020, Vol 21, Issue 5, p1
- ISSN
1530-9932
- Publication type
Article
- DOI
10.1208/s12249-020-01740-x