SIMULATION OF THE IN VIVO EXPOSURE TO
IBUPROFEN BASED ON IN VITRO DISSOLUTION
PROFILES FROM SOLID DOSAGE FORMS
DANIELA ELENA POPA1, DUMITRU LUPULIASA2, ANA-ANDREEA
STĂNESCU2*, MARIA BÂRCĂ1, GEORGE TRAIAN ALEXANDRU
BURCEA DRAGOMIROIU1, DALIA SIMONA MIRON3, FLAVIAN
ȘTEFAN RĂDULESCU4
University of Medicine and Pharmacy „Carol Davila” Bucharest,
Faculty of Pharmacy, 6th Traian Vuia street, 020956, Bucharest,
Romania.
1Department of Drug Control,
2Department of Pharmaceutical Technology and Biopharmaceutics,
3Department of Pharmaceutical Physics and Informatics,
4Department of Drug Industry and Pharmaceutical Biotechnologies.
* corresponding author: aastanescu@gmail.com
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Abstract:

Four ibuprofen products in two or three concentrations of active pharmaceutical ingredient were evaluated in vitro, using the conditions recommended for the upper pHvalue of the three stage dissolution testing. The experimental data were included in the in silico prediction of the plasma concentration profiles, with consecutive analysis of the main pharmacokinetic parameters and assessment of the bioequivalence with the official reference drug product for the intermediate, 400 mg concentration. The results indicated an apparent feasibility of the biowaiver procedures, based on the dissolution similarity. Even when significantly different release profiles were obtained in vitro, the in vivo bioequivalence was concluded. The high permeability characteristic seems to be the key
factor controlling the absorption profile of ibuprofen.

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