Statistical Evaluation of Influence of Polymers Concentration on Disintegration Time and Diazepam Release from Quick Disintegrating Rapid Release Tablet

Abstract

  This study describes the formulation of rapidly disintegrating, fast dissolving diazepam tablets intended for use in the oral cavity. The tablets were prepared by the conventional wet granulation method using solid dispersion of the drug with PEG-4000 and/or PEG-6000. A 3² factorial design was used to reduce the number of experimental runs and to obtain several formulations by which tablets disintegrated within 3 min and released 85% of the drug in less than 30 min. Several tablet formulations prepared with different amounts of PEGs in solid dispersion met the above two criteria. However, tablets which were prepared with PEG-4000 alone at the lowest concentration disintegrated in the shortest time (32.12 sec) and released 85% of the drug most rapidly (11.03 min).