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

• Main Authors: Marival Bermejo, Jessica Meulman, Marcelo Gomes Davanço, Patricia de Oliveira Carvalho, Isabel Gonzalez-Alvarez, Daniel Rossi Campos
• Format: Article
• Language: English
• Published: MDPI AG 2020-06-01
• Series: Pharmaceutics
• Subjects: carbamazepine; in vitro in vivo correlation; dissolution; biopredictive; bioequivalence; biowaiver
• Online Access: https://www.mdpi.com/1999-4923/12/6/558

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.