Candesartan cilexetil tablets - study of factors, influencing release profiles and the potential for tableting after fluidized bed granulation

Authors: B. Tzankov, S. Tzankov,

Abstract

The present study evaluated the possibility tableting after granulation under fluid bed conditions to be used as suitable method for preparation of candesartan cilexetil - containing tablets,having a similarity factor to the reference product above 50.00. Different parameters, such as the influence of excipients, size of granules and technological regime on drug release profile were investigated in order predetermined requirements to be met.

It was found that only the mechanical addition of surfactant and change of the size of granules, used for tableting did not lead to satisfactory results. A suitable technological regime was required to achieve the biopharmaceutical requirements.The suitability of the technology was demonstrated by comparison of the tablet release profiles, obtained by different methods, in media with different pH values (pH 6.5, pH 4.5 and pH 1.2).Our results show that the addition of granulation liquid, containing 5% low substituted hydroxypropyl cellulose and 2.5% diethylene glycol mono-ethyl ether,under fluid bed conditions, led to drug release profiles, satisfied biopharmaceutical requirements in all the used media.

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