In Vivo Predictive Dissolution (IPD) for Carbamazepine Formulations: Additional Evidence Regarding a Biopredictive Dissolution Medium

The aim of the present study was to bring additional evidence regarding a biopredictive dissolution medium containing 1% sodium lauryl sulphate (SLS) to predict the in vivo behavior of carbamazepine (CBZ) products. Twelve healthy volunteers took one immediate release (IR) dose of either test and ref...

Full description

Saved in:
Bibliographic Details
Published in:Pharmaceutics 2020-06, Vol.12 (6), p.558
Main Authors: Bermejo, Marival, Meulman, Jessica, Davanço, Marcelo Gomes, Carvalho, Patricia de Oliveira, Gonzalez-Alvarez, Isabel, Campos, Daniel Rossi
Format: Article
Language:English
Subjects:
Bioequivalence
biopredictive
biowaiver
carbamazepine
dissolution
Drug dosages
in vitro in vivo correlation
Pharmacokinetics
Plasma
Product development
Citations: Items that this one cites
Items that cite this one
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary:The aim of the present study was to bring additional evidence regarding a biopredictive dissolution medium containing 1% sodium lauryl sulphate (SLS) to predict the in vivo behavior of carbamazepine (CBZ) products. Twelve healthy volunteers took one immediate release (IR) dose of either test and reference formulations in a bioequivalence study (BE). Dissolution profiles were carried-out using the medium. Level A in vitro–in vivo correlations (IVIVC) were established using both one-step and two-step approaches as well as exploring the time-scaling approach to account for the differences in dissolution rate in vitro versus in vivo. A detailed step by step calculation was provided to clearly illustrate all the procedures. The results show additional evidence that the medium containing 1% SLS can be classified as a universal biopredictive dissolution tool, and that both of the approaches used to develop the IVIVC (one and two-steps) provide good in vivo predictability. Therefore, this biopredictive medium could be a highly relevant tool in Latin-American countries to ensure and check the quality of their CBZ marketed products for which BE studies were not requested by their regulatory health authorities.
ISSN:1999-4923
1999-4923
DOI:10.3390/pharmaceutics12060558