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
*corresponding author: stoicescusilvia@yahoo.com
#All authors have equally contributed to the current paper.
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Abstract:
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 (flowthrough
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.

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