THE LACK OF BIOLOGICAL RELEVANCE OF
THE OFFICIAL IN VITRO DISSOLUTION
METHODOLOGY FOR THE IMMEDIATE
RELEASE SOLID ORAL DOSAGE FORMS OF
KETOCONAZOLE
MITU MIRELA ADRIANA1, RĂDULESCU FLAVIAN ŞTEFAN2*,
HÎRJĂU MIRCEA1, LUPULEASA DUMITRU1, DUMITRESCU IONBOGDAN3,
MIRON DALIA SIMONA3
University of Medicine and Pharmacy „Carol Davila” Bucharest,
Faculty of Pharmacy, 6th Traian Vuia street, 020956, Bucharest,
Romania.
1Department of Pharmaceutical Technology and Biopharmaceutics,
2Department of Drug Industry and Pharmaceutical Biotechnologies,
3Department of Pharmaceutical Physics and Informatics
*corresponding author: flavian_stefan@yahoo.com
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Abstract:

The paper presents the effect of drastic pH variations during in vitro drug release tests on the dissolution profiles of ketoconazole reference immediate release oral solid dosage form. The acidic media induced a rapid and almost complete dissolution of ketoconazole, while the pH change determined an accelerated and continuous precipitation process, almost not dependent on the stirring rate. The results indicate that for generic drug products containing lipophilic weak bases, a rapid dissolution compared to the reference product could explain the reduced biopharmaceutical performances.

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