Formulation and Optimization of Stable Aspirin 100mg Tablets

Abstract

Several moisture and temperature-sensitive medicines cannot be manufactured in Sudan due to extreme climatic conditions. Keeping these factors under control during production is difficult task. It is possible to overcome these difficulties by using excipients and utilizing technology in the production of the drug. This study aimed to adjust and improve the formulation of aspirin using different excipients and different technological approaches to produce stable aspirin tablets. Microcrystalline cellulose and lactose were used as fillers and stearic acid as a lubricant, four aspirin formulations, two formulations containing lactose and two formulations containing microcrystalline cellulose were prepared for aspirin 100 mg. For each formulation, wet granulation and direct compression techniques were applied separately, to study the effect of manufacturing technology and the role of excipients on the stability of the product. Prepared tablets were subjected to various quality control tests. Lactose had lower moisture content than MCC. But MCC has moisture scavenger characteristic. Direct-compression CDs with MCC shows less degradation than other tablet formulations. Addition of stearic acid as a substitute for magnesium stearate (a lubricant) changes the overall pH to more acidic which reduces hydrolysis.