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In Vivo Predictive Dissolution (IPD) for Carbamazepine Formulations: Additional Evidence Regarding a Biopredictive Dissolution Medium.
Pharmaceutics. 2020 Jun 17; 12(6)P

Abstract

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.

Authors+Show Affiliations

Department of Engineering, Pharmacy and Pharmaceutical Technology Area, Facultad de Farmacia, University Miguel Hernandez de Elche, San Juan de Alicante, 03550 Alicante, Spain.Faculty of Pharmaceutical Sciences, University of Campinas-UNICAMP, Campinas, 13083-871 São Paulo, Brazil.Postgraduate Program in Health Sciences, Universidade São Francisco, Bragança Paulista, 12916-900 São Paulo, Brazil.Postgraduate Program in Health Sciences, Universidade São Francisco, Bragança Paulista, 12916-900 São Paulo, Brazil.Department of Engineering, Pharmacy and Pharmaceutical Technology Area, Facultad de Farmacia, University Miguel Hernandez de Elche, San Juan de Alicante, 03550 Alicante, Spain.Postgraduate Program in Health Sciences, Universidade São Francisco, Bragança Paulista, 12916-900 São Paulo, Brazil.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

32560369

Citation

Bermejo, Marival, et al. "In Vivo Predictive Dissolution (IPD) for Carbamazepine Formulations: Additional Evidence Regarding a Biopredictive Dissolution Medium." Pharmaceutics, vol. 12, no. 6, 2020.
Bermejo M, Meulman J, Davanço MG, et al. In Vivo Predictive Dissolution (IPD) for Carbamazepine Formulations: Additional Evidence Regarding a Biopredictive Dissolution Medium. Pharmaceutics. 2020;12(6).
Bermejo, M., Meulman, J., Davanço, M. G., Carvalho, P. O., Gonzalez-Alvarez, I., & Campos, D. R. (2020). In Vivo Predictive Dissolution (IPD) for Carbamazepine Formulations: Additional Evidence Regarding a Biopredictive Dissolution Medium. Pharmaceutics, 12(6). https://doi.org/10.3390/pharmaceutics12060558
Bermejo M, et al. In Vivo Predictive Dissolution (IPD) for Carbamazepine Formulations: Additional Evidence Regarding a Biopredictive Dissolution Medium. Pharmaceutics. 2020 Jun 17;12(6) PubMed PMID: 32560369.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - In Vivo Predictive Dissolution (IPD) for Carbamazepine Formulations: Additional Evidence Regarding a Biopredictive Dissolution Medium. AU - Bermejo,Marival, AU - Meulman,Jessica, AU - Davanço,Marcelo Gomes, AU - Carvalho,Patricia de Oliveira, AU - Gonzalez-Alvarez,Isabel, AU - Campos,Daniel Rossi, Y1 - 2020/06/17/ PY - 2020/04/30/received PY - 2020/06/01/revised PY - 2020/06/10/accepted PY - 2020/6/21/entrez PY - 2020/6/21/pubmed PY - 2020/6/21/medline KW - bioequivalence KW - biopredictive KW - biowaiver KW - carbamazepine KW - dissolution KW - in vitro in vivo correlation JF - Pharmaceutics JO - Pharmaceutics VL - 12 IS - 6 N2 - 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. SN - 1999-4923 UR - https://www.unboundmedicine.com/medline/citation/32560369/In_Vivo_Predictive_Dissolution_(IPD)_for_Carbamazepine_Formulations:_Additional_Evidence_Regarding_a_Biopredictive_Dissolution_Medium L2 - https://www.mdpi.com/resolver?pii=pharmaceutics12060558 DB - PRIME DP - Unbound Medicine ER -
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