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In vitro-in vivo correlation for nevirapine extended release tablets.
Biopharm Drug Dispos. 2009 Dec; 30(9):542-50.BD

Abstract

An in vitro-in vivo correlation (IVIVC) for four nevirapine extended release tablets with varying polymer contents was developed. The pharmacokinetics of extended release formulations were assessed in a parallel group study with healthy volunteers and compared with corresponding in vitro dissolution data obtained using a USP apparatus type 1. In vitro samples were analysed using HPLC with UV detection and in vivo samples were analysed using a HPLC-MS/MS assay; the IVIVC analyses comparing the two results were performed using WinNonlin. A Double Weibull model optimally fits the in vitro data. A unit impulse response (UIR) was assessed using the fastest ER formulation as a reference. The deconvolution of the in vivo concentration time data was performed using the UIR to estimate an in vivo drug release profile. A linear model with a time-scaling factor clarified the relationship between in vitro and in vivo data. The predictability of the final model was consistent based on internal validation. Average percent prediction errors for pharmacokinetic parameters were <10% and individual values for all formulations were <15%. Therefore, a Level A IVIVC was developed and validated for nevirapine extended release formulations providing robust predictions of in vivo profiles based on in vitro dissolution profiles.

Authors+Show Affiliations

Drug Metabolism and Pharmacokinetics, Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877, USA. sreeraj.macha@boehringer-ingelheim.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Controlled Clinical Trial
Journal Article
Validation Study

Language

eng

PubMed ID

19876936

Citation

Macha, Sreeraj, et al. "In Vitro-in Vivo Correlation for Nevirapine Extended Release Tablets." Biopharmaceutics & Drug Disposition, vol. 30, no. 9, 2009, pp. 542-50.
Macha S, Yong CL, Darrington T, et al. In vitro-in vivo correlation for nevirapine extended release tablets. Biopharm Drug Dispos. 2009;30(9):542-50.
Macha, S., Yong, C. L., Darrington, T., Davis, M. S., MacGregor, T. R., Castles, M., & Krill, S. L. (2009). In vitro-in vivo correlation for nevirapine extended release tablets. Biopharmaceutics & Drug Disposition, 30(9), 542-50. https://doi.org/10.1002/bdd.691
Macha S, et al. In Vitro-in Vivo Correlation for Nevirapine Extended Release Tablets. Biopharm Drug Dispos. 2009;30(9):542-50. PubMed PMID: 19876936.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - In vitro-in vivo correlation for nevirapine extended release tablets. AU - Macha,Sreeraj, AU - Yong,Chan-Loi, AU - Darrington,Todd, AU - Davis,Mark S, AU - MacGregor,Thomas R, AU - Castles,Mark, AU - Krill,Steven L, PY - 2009/10/31/entrez PY - 2009/10/31/pubmed PY - 2010/1/26/medline SP - 542 EP - 50 JF - Biopharmaceutics & drug disposition JO - Biopharm Drug Dispos VL - 30 IS - 9 N2 - An in vitro-in vivo correlation (IVIVC) for four nevirapine extended release tablets with varying polymer contents was developed. The pharmacokinetics of extended release formulations were assessed in a parallel group study with healthy volunteers and compared with corresponding in vitro dissolution data obtained using a USP apparatus type 1. In vitro samples were analysed using HPLC with UV detection and in vivo samples were analysed using a HPLC-MS/MS assay; the IVIVC analyses comparing the two results were performed using WinNonlin. A Double Weibull model optimally fits the in vitro data. A unit impulse response (UIR) was assessed using the fastest ER formulation as a reference. The deconvolution of the in vivo concentration time data was performed using the UIR to estimate an in vivo drug release profile. A linear model with a time-scaling factor clarified the relationship between in vitro and in vivo data. The predictability of the final model was consistent based on internal validation. Average percent prediction errors for pharmacokinetic parameters were <10% and individual values for all formulations were <15%. Therefore, a Level A IVIVC was developed and validated for nevirapine extended release formulations providing robust predictions of in vivo profiles based on in vitro dissolution profiles. SN - 1099-081X UR - https://www.unboundmedicine.com/medline/citation/19876936/In_vitro_in_vivo_correlation_for_nevirapine_extended_release_tablets_ L2 - https://doi.org/10.1002/bdd.691 DB - PRIME DP - Unbound Medicine ER -