Abstract
Recently, the fast disintegrating tablet (FDT) has started gaining popularity and acceptance as a new drug delivery system. Lubricants could influence on disintegration time (DT), hardness, wetting time (WT) and dissolution of FDT. This study investigated the effects of amount and type of lubricants (magnesium stearate and sodium stearyl fumarate) as well as compression force on characteristics of the cetirizine dihydrochloride (CD) FDT. The spatial distribution of lubricants in tablets had been analyzed using Raman mapping and scanning electron microscopy–energy dispersive X-ray spectroscopy. The more concentration of lubricants or higher compression force resulted in more distribution of lubricant therefore hindering water penetration into the tablet. In addition, CD FDT was prepared by direct compression method. A 32 full factorial design was applied for the optimization of CD FDT. By adopting a systematic formulation approach, the closeness between predicted and observed values (DT, WT, contact angle, surface free energy, hardness) indicated the validity of derived equations for the dependent variables. Sodium stearyl fumarate had less impact on hardness and disintegration time than magnesium stearate. Therefore, FDT containing sodium stearyl fumarate as lubricant showed higher drug release than that containing magnesium stearate.
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