Romanian Society of Pharmaceutical Sciences
 

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ADJUSTMENTS OF THE BIORELEVANT DISSOLUTION TESTING IN CASE OF OXICAMS ORAL SOLID DOSAGE FORMS

ION-BOGDAN DUMITRESCU1, IOANA DUMITRA DRĂGOICEA2, DUMITRU LUPULEASA3, DOINA DRAGANESCU1, DRAGOŞ FLORIAN CIOLAN4, DALIA SIMONA MIRON1*, FLAVIAN ŞTEFAN RĂDULESCU5

Carol Davila University of Medicine and Pharmacy, Faculty of Pharmacy, 6 Traian Vuia street, 020956, Bucharest, Romania.
1Department of Pharmaceutical Physics and Informatics,
2Clinical Emergency Hospital, Department of Plastic and Reconstructive Microsurgery,
3Department of Pharmaceutical Technology and Biopharmaceutics,
4Department of Pharmaceutical Chemistry,
5Department of Drug Industry and Pharmaceutical Biotechnologies.

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The paper presents the results of in vitro dissolution testing for oral solid dosage forms containing three representative oxicams in blank or standard, fast and fed state simulated intestinal fluids (FaSSIF/FeSSIF). Non-compendial PeakTM vessel were used in combination with an adapted composition of biorelevant media (1:2 dilution with the corresponding aqueous buffer system). The results revealed a significant contribution of the improved stirring profile to the release process in FeSSIF, counterbalancing the decreased concentration of endogenous tensioactive compounds. The dissolution efficiency was comparable for the two blank media. The implemented changes in composition of the biorelevant media and experimental design leaded to comparable variability of data, but request further evaluation of the discriminatory character for internal, formulationcontrolled factors.