COMPARATIVE ASSESSMENT OF THE IN VITRO PERFORMANCE FOR MODIFIED RELEASE TABLETS CONTAINING PENTOXIFYLLINE USING PADDLE METHOD AND FLOWTHROUGH CELLS
IOANA ANDREEA POPESCU1, CĂTĂLIN DONEA1*, DUMITRU LUPULEASA1, ANCA CECILIA NICOARĂ1, DANIELA ELENA POPA2, DALIA SIMONA MIRON3, FLAVIAN ȘTEFAN RĂDULESCU4
“Carol Davila” University of Medicine and Pharmacy Bucharest, Faculty of Pharmacy, 6 Traian Vuia Street, 020956,
1.Department of Pharmaceutical Technology and Biopharmaceutics
2.Department of Drug Control
3.Department of Pharmaceutical Physics and Informatics
4.Department of Drug Industry and Pharmaceutical Biotechnologies
Download Full Article PDF
The paper analyzed the impact of hydrodynamic differences existing between the two types of compendial apparatuses on the
in vitro performance of modified release oral solid dosage forms containing pentoxifylline. The experimental conditions were
selected based on the previsions of dissolution test 5 of the United States Pharmacopoeia, with previous reports suggesting
the feasibility of in vitro/in vivo correlations. Despite the distinct kinetics probably induced by swelling and erosion
differences, the mean release profiles were similar for the evaluated products and compliant with the same acceptance limits.
Considering the high water solubility of the active pharmaceutical ingredient, the sink conditions requirements were fulfilled
for the flow-through design even when the stationary volume of the cells was considered. A new criterion for selection of
calibration products for performance verification test was suggested.