CHARACTERIZATION OF PARACETAMOL ORALLY DISINTEGRATING TABLET USING GELATIN 1% AND 2% AS BINDER AND POLYPLASDONE XL-10 10% AS DISINTEGRANT (Prepared by Freeze Drying Method)

Paracetamol, a para-aminophenol derivative, is usually given per oral as antipyretic and analgesic for the treatment of fever1. Pediatric patients may have difficulty in ingesting conventional tablets because of their underdeveloped muscular and nervous systems2. The concept of Orally Disintegrating Tablets (ODT) emerged with an objective to improve patient’s compliance. ODTs disintegrates and dissolves in the mouth in less than 1 minute without the need of water3. Various technologies used in the manufacture of ODT include freeze drying, moulding, direct compression, spray drying, sublimation, and mass extrusion. In the freeze drying method, drying is carried out at low temperature under conditions involving removal of water by sublimation. Here, the drug is physically entrapped in a water soluble matrix, which is then freeze dried to give a product that is highly porous and amorf3. Freeze drying has some disadvantages such as the product obtained has poor mechanical stability and fragile4. Gelatin can inhibit the recrystallization process of amorphous paracetamol by cross-linking and hydrogen bonding between paracetamol and polymer. This interaction may increase the mechanical strength of ODT and keep the amorphous structure5. This study aims to determine the characterization of paracetamol ODT using gelatin as binder (1% and 2%)6, polyplasdone XL-10 as disintegrant (10%)7, and mannitol as filler which prepared by freeze drying method. Paracetamol ODT, physical mixture, and single compound of the material were characterized using Powder X-ray Diffractometry (PXRD), Differential Thermal Analyzer (DTA), and Scanning Electron Microscope (SEM)