Formulation development of chlorpheniramine maleate tablet by direct compression

ABSTRACT

Direct compression has continued to grow in pharmaceutical industries, since it cuts down the laborious events, faced in wet or dry granulation. The study aims at developing a new tablet formulation of chlorpheniramine maleate [4mg], using microcrystalline cellulose [Avicel PH 102], lactose DC, starch, tale, and magnesium stearate by direct compression. Different pharmacopoeial and non-pharmacopoeial tests were conducted to evaluate the characteristics of tablets. The new directly compressible tablets met the official standards and showed a percent drug release of 94.95 within 45 minutes and the assay was 100.66%. Results were compared with three commercially marketed tablet brands of chlorpheniramine maleate. Tablets were blister packed, and stability studies were carried out at room temperature and accelerated stability conditions. The analysis of stability was in accordance with the official limits, showing no substantial change during storage period. The physico-chemical data reveal that low dose drugs could be developed by a direct compression technique using suitable directly compressible excipients since it is a simplest, time saving and cost effective method of manufacturing