Formulation of Rapidly Disintegrating Fast Dissolving Diazepam Tablets Using Solid Dispersions through a Statistical Approach

This study present development of diazepam tablet, which can provide rapid disintegration of the tablet as well as rapid release of the drug in the oral cavity. The tablets were prepared by direct compression method using solid dispersion of the drug with polyethylene glycol and/or sodium lauryl sulphate as solid dispersion to increase aqueous solubility and dissolution of drug. A 2³ factorial design was used to limit the number of experimental trials and to optimize the formulations which disintegrate rapidly and release the drug immediately. Out of the eight formulations five formulations complied the criteria of rapidly disintegrating fast dissolving tablets. The optimum formulation was found to disintegrate in 26.12 seconds and released 85% of the drug in 10.13 minutes. This study indicates that rapidly disintegrating fast dissolving tablet can be prepared by the conventional direct compression method utilizing the existing infrastructure of tablet manufacturing and could provide rapid absorption of drug by quick disintegration of the tablet and rapid release of the drug in the oral cavity for emergency treatment of seizure.