Romanian Society of Pharmaceutical Sciences

« Back to Farmacia Journal 3/2018

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

Download Full Article PDF

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.