Romanian Society of Pharmaceutical Sciences
 

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COMPARISON OF THE IN VITRO DISSOLUTION PROFILES FOR A HIGH SOLUBILITY DRUG FROM IMMEDIATE RELEASE FORMULATIONS USING USP APPARATUSES 3 AND 4

MONICA ARDELEAN 1#, SILVIA MARIA STOICESCU 2#*, CĂTĂLINA LILIANA ANDREI 3#, DUMITRU LUPULIASA 1,4#, HORAȚIU MARIUS VIZITEU 1,4#, DALIA SIMONA MIRON 4,5#, SIMONA ARDELEAN 6#, MIRELA ADRIANA MITU 1#

1.“Carol Davila” University of Medicine and Pharmacy, Faculty of Pharmacy, Department of Pharmaceutical Technology and Biopharmaceutics, 6 Traian Vuia Street, 020956, Bucharest, Romania
2 .“Carol Davila” University of Medicine and Pharmacy, Faculty of Medicine, Department of Obstetrics and Gynaecology, “Polizu” Clinical Hospital, Bucharest, Romania
3 .“Carol Davila” University of Medicine and Pharmacy, Faculty of Medicine, Department of Cardiology and Thoracic Pathology, Bucharest, Romania
4 .“Carol Davila” University of Medicine and Pharmacy, Faculty of Pharmacy, Center for Drug Sciences (CedS), 6 Traian Vuia Street, 020956, Bucharest, Romania
5 .“Carol Davila” University of Medicine and Pharmacy, Faculty of Pharmacy, Department of Pharmaceutical Physics and Informatics, 6 Traian Vuia Street, 020956, Bucharest, Romania
6 .“Vasile Goldiș” Western University, Faculty of Pharmacy, Arad, Romania

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The current paper represents the continuation of a previous report focusing on the role of in vitro dissolution testing in the estimation of the in vivo performance for immediate release solid oral dosage forms containing a BCS class 3 drug, metformin hydrochloride. The methodology was extended by application of alternative compendial apparatuses (flow-through cells and reciprocating cylinders, using basket or paddle method as reference) and testing of a higher strength (850 mg). The experimental results suggested the complementarity of information generated by different hydrodynamic parameters and volumes of media.