DefinePK

Abstract

Fast dissolving drug delivery system offers a solution for those patients having difficulty in swallowing tablet. In the present study, an attempt has been made to prepare taste-masked fast dissolving tablets of two drugs, Amitriptyline and Mirtazapine  using Primojel as and MCC as superdisintegrants and Camphor as subliming agent by direct compression technique. Both the drugs have bitter taste and pertaining to that patient compliance is less. Initially, the cation exchange resins Tulsion 335, Tulsion 339, Tulsion 344 were selected to prepare drug resin complex for masking the bitter taste of selected drugs. Finally, Tulsion 344 was used further for the study as this resin showed maximum drug loading. Six trial batches were prepared with each drug to find out the appropriate superdisintegrants. Based on the evaluation of trial batches, Primojel was selected for formulating the final batches by using Box-Behnken optimization tool. Concentration of superdisintegrants, Primojel & MCC and subliming agent Camphor were chosen as independent parameters and disintegration time (DT), % friability and % drug release were selected as dependent variables. The prepared tablets belong to trial batches and factorial batches were evaluated for pre-compression and post-compression parameters. The hardness of the tablets was in the range of 3.42-4.87 Kg/cm2 and 3.55-4.98 Kg/cm2 for Amitriptyline and Mirtazapine, respectively. The percentage friability of the tablets was less than one. Weight variation test results showed that the tablets were deviating from the average weight within the permissible limits of ±7.5 %. Drug content uniformity study results showed that uniform dispersion of the drug throughout the formulation i.e. 90.26%-99.97% for Amitriptyline and 92.82%-99.95% for Mirtazapine. An optimized batch was selected based on results obtained with ANOVA and evaluation parameters. Optimized batches of both the drugs showed better disintegrating character along with the rapid release (99.38±1.15% &  99.12±1.17%) for Amitriptyline and Mirtazapine, respectively, within 30 minutes. It was observed that there was no physical changes in the optimized formulations till the complete time period of stability. The drug content in the optimized formulations was found to be 99.05±1.12% (Aopt) and 99.11±1.11% (Mopt) at the end of three (03) months