Romanian Society of Pharmaceutical Sciences
 

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THE INFLUENCE OF SPLITTING ON THE IN VITRO RELEASE OF METOPROLOL SUCCINATE FROM SCORED TABLETS

GEORGE TRAIAN ALEXANDRU BURCEA DRAGOMIROIU1, OCTAV GINGHINĂ2, DALIA SIMONA MIRON3*, MARIA BÂRCĂ1, DANIELA ELENA POPA1, MIRCEA HÎRJĂU4, DUMITRU LUPULEASA4, FLAVIAN ȘTEFAN RĂDULESCU5

1.University of Medicine and Pharmacy “Carol Davila” Bucharest, Faculty of Pharmacy, Department of Drug Control, 6 Traian Vuia street, 020956, Bucharest, Romania
2.University of Medicine and Pharmacy “Carol Davila” Bucharest, Faculty of Dental Medicine, Department of Oncological Surgery, „Sf. Ioan” Hospital, 13 Vitan-Bârzești street, 042122, Bucharest, România
3.University of Medicine and Pharmacy “Carol Davila” Bucharest, Faculty of Pharmacy, Department of Pharmaceutical Physics and Informatics, 6 Traian Vuia street, 020956, Bucharest, Romania
4.University of Medicine and Pharmacy “Carol Davila” Bucharest, Faculty of Pharmacy, Department of Pharmaceutical Technology and Biopharmaceutics, 6 Traian Vuia street, 020956, Bucharest, Romania
5.University of Medicine and Pharmacy “Carol Davila” Bucharest, Faculty of Pharmacy, Department of Drug Industry and Pharmaceutical Biotechnologies, 6 Traian Vuia street, 020956, Bucharest, Romania

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The paper presents the results of in vitro release tests applied for assessing the impact of mechanical splitting on the performance of sustained release oral solid formulations containing metoprolol succinate. Ten multiparticulate drug delivery systems of the same manufacturer available on the European market, with dose strengths between 23.75 to 190 mg, were evaluated according to the conditions specified in the United States Pharmacopoeia monograph for six hours. The similarity of the mean in vitro release profiles was concluded between the split and finished drug product, respectively the corresponding lower dose. A higher variability of the experimental data was noted for the divided lower strength, probably due to the reduced reproducibility of the splitting in terms of surface area and morphology. The results demonstrated that the mechanical splitting didn’t alter the mechanism nor the amount released.