Formulation, development and evaluation of paracetamol tablet by moisture activated dry granulation (MADG) process

Paracetamol, also known as acetaminophen, is a painkiller that is popular throughout the world because it does not irritate the stomach. Paracetamol was first discovered to have both analgesic and antipyretic properties in the late nineteenth century. The aim of present work was to Formulate, develop and evaluate Paracetamol Tablets by Moisture Activated Dry Granulation (MADG) process to short manufacturing time and process variables as compared with convention process. Colloidal anhydrous silica is used in the formulation to absorb the extra moisture present in the MADG process formulation. A total number of five formulations were prepared and weight of all tablets kept constant. i.e. 595 mg. All the formulations resulted in acceptable limit. The final batch F3 (contained PVPK 3% and Kollidon 90F 4%) considered as optimized batch which gives the release up to 95.38 % in 30 min. All Pre-compression parameters like Carr’s Index, Hausner’s Ratio and Angle of Repose met the standard values indicating good flow properties. The average weight, friability and hardness were within compendia limits. Drug content uniformity was within acceptable limits. The result of stability study of the batch F3 showed that there was no significant change in Hardness, Friability, In-vitro Disintegration time, The optimized formulation batch F3 showed better drug release profile with other formulations. The PCM tablets prepared by MADG process had advantages such as short manufacturing time and few critical formulation and process variables when compared with convention wet granulation process.