FORMULATION AND EVALUATION OF FAST DISSOLVING TABLET OF PARACETAMOL AND CHLORPHENIRAMINE MALEATE

The aim of the present work was to formulate and evaluate Fast Dissolving Tablet (FDT) of a combined oral dosage form of Paracetamol (PCM) and Chlorpheniramine Maleate (CPM). Paracetamol is an antipyretic and Chlorpheniramine maleate is an antihistamine used to relieve symptoms of hay fever, allergy, and the common cold. Combining both the drugs can be used as pain-relieving and fever in cold and flu conditions. Three super disintegrating agents such as Cross Carmellose Sodium (CCS), Sodium Starch Glycollate (SSG) and Microcrystalline Cellulose (MCC) at different concentrations were used to enhance the disintegration and to improve the bioavailability of the drugs. By using the direct compression method, the FDT’s were prepared and evaluated for hardness, weight variation, wetting time, friability, disintegration time, in-vitro dissolution study, Thermogravimetric Analysis (TGA), and stability studies. A new Spectrophotometric method was developed for simultaneous estimation of PCM and CPM in FDT. Among all six formulations, F2 with CCS 27% concentration found the best formulation. F2 resulted in best wetting time i.e. 26 sec, good water absorption ratio i.e. 81%, fastest disintegration time i.e. 20 sec and faster drug release within 25 min. No changes in drug release upon storage on different temperature and humidity was estimated in stability studies. The results showed that croscarmellose sodium as the superdisintegrants was ideal. The result indicates that FDT of a combined oral dosage form of PCM and CPM can be successfully explored and employed in the therapy of pain and fever in cold and flu conditions.