Mourad A. 1, Miron Dalia Simona 2, Lupuleasa D. 1, Budura Emma Adriana 1, Voicu A. V. 3
1 University of Medicine and Pharmacy „Carol Davila” Bucharest Department of Pharmaceutical Technology and Biopharmaceutics
2 University of Medicine and Pharmacy „Carol Davila” Bucharest Department of Pharmaceutical Physics and Informatics
3 University of Medicine and Pharmacy „Carol Davila” Bucharest Faculty of Medicine, Department of Clinical Pharmacology, Toxicology and Psychopharmacology
Abstract
The paper describes the applicability of in-vitro in-vivo correlations previously developed for modified-release formulations of trimetazidine dihydrochloride (35 mg) to the immediate release products (20 mg). The dissolution profiles obtained in three different media were used for prediction of the invivo pharmacokinetic profiles, after oral administration as single dose. The accuracy of prediction were analyzed by comparison of estimated versus experimental values of peak and global exposure. Although water is far from being a biorelevant media, the integration of the corresponding in-vitro drug release profiles resulted in the most adequate prediction of peak exposure for this particular, high solubility, high permeability drug.