FORMULATION AND IN VITRO EVALUATION OF RAPIDLY DISINTEGRATING TABLETS OF LORATADINE

The aim of the present research work is to evaluate the impact of superdisintegrants in the formulation and evaluation of rapidly disintegrating tablets. In the present study, Loratadine is the model drug. Rapidly disintegrating tablets of Loratadine was prepared by direct compression method. In this method the different excipients used were Calcium Silicate (FM1000), Pharmattose DCl-21 (anhydrous lactose), Citric acid(anhydrous), Colloidal Silica (Aerosil), Sodium stearyl fumarate, Magnesium Stearate, Crosscarmellose Sodium (AcDiSol), L-HPC( Low substituted hydroxyl propyl cellulose), Microcrystalline Cellulose (Avicel pH-200), Aspartame, Orange flavor and Strawberry flavor. The formulations containing Crosscarmellose sodium and Low substituted hydroxyl-propyl-cellulose as superdisintegrants, disintegrated faster compared to the formulation containing Microcrystalline Cellulose (Avicel pH-200). Pre compression and post compression parameters were evaluated for all eight formulations (F1-F8).Infra-Red study revealed that all polymers and excipients used were compatible with the drug. In vitro drug release showed that almost drug was release in the range of 94-97% range in 10 minutes. Depending upon cumulative drug release, in vitro disintegration time, wetting time results, one formulation F8 was selected for stability studies and subjected to stability studies at 25⁰C, 30⁰C and 40⁰ C for 1 month. Overall, formulation F8 was found to be the best formulation in direct compression method.