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THE OPTIMIZATION OF PROLONGED RELEASE MULTIPARTICULATE TABLETS WITH BETAHISTINE DIHYDROCHLORIDE – Part II

RADU CAZACINCU¹, MIRCEA HÎRJĂU^2*, DUMITRU LUPULEASA²

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The influence of some formulation factors on the release of betahistine dihydrochloride, an active ingredient freely soluble in water, from multiparticulate tablets with prolonged release was studied. Prolonged release multiparticulate tablets of betahistine dihydrochloride were prepared by compressing prolonged release granules obtained via fluid bed granulation and coating. They were mixed with the suitable excipients (micro-crystalline cellulose -Vivapur type 102 as filler, talcum as lubricant, colloidal anhydrous silica dioxide – Aerosil as glidant). The fluid bed coating is currently a widely used technique because it allows, among other applications, the coating of crystals or granules with a variety of available polymers, providing modified release systems [1]. In order to obtain a prolonged release drug delivery system, Eudragit® RL and Eudragit® RS polymers were used as coating agents. The formulation variables studied were the type of the coating polymers and their quantitative ratio, as well as the coating percentages. The results show that the percentage of polymer used in the tablet formulation has the most significant influence on the drug release.