Romanian Society of Pharmaceutical Sciences

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INFLUENCE OF SOME FORMULATION FACTORS ON THE RELEASE OF PHENYTOIN SODIUM FROM HYDROPHILIC MATRIX TABLETS

GABRIEL ȘARAMET1, FLAVIAN ȘTEFAN RĂDULESCU2, ȘTEFANIA-FELICIA BĂRBUCEANU3, DALIA SIMONA MIRON4, CĂTĂLINA ANCUȚA FIȚA1*, MIRELA ADRIANA MITU1, ANDREEA STĂNESCU1, DUMITRU LUPULIASA1

University of Medicine and Pharmacy ”Carol Davila” Bucharest, Faculty of Pharmacy
1.Department of Pharmaceutical Technology and Biopharmacy
2.Department of Drug Industry and Pharmaceutical Biotechnologies
3.Department of Organic Chemistry
4.Department of Pharmaceutical Physics and Informatics

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The aim of this study was the formulation and evaluation of extended release sodium phenytoin tablets based on hydroxypropylmethylcellulose (HPMC) hydrophilic matrix. Different ratios of active ingredient, HPMC and fillers were used. Methocel® K15M Premium CR Grade was the chosen HPMC sort, while Starch 1500 was chosen as filler, both materials showing swelling properties when wet. The formulations were mechanically evaluated, then a set of in vitro release tests were performed on the tablets. For each formulation, dissolution was carried out at three stirring speeds and in two types of vessels. Dissolution profiles were obtained for each experiment and that data was fitted on the usual release models. It was discovered that certain combinations of excipients can result in a change of release kinetics.