Romanian Society of Pharmaceutical Sciences
 

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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.
1.Department of Drug Control,
2.Department of Pharmaceutical Technology and Biopharmaceutics,
3.Department of Pharmaceutical Physics and Informatics,
4.Department of Drug Industry and Pharmaceutical Biotechnologies.

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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.