Preparation and characterization of spherical agglomerates of mefenamic acid by neutralization method

Abstract

Mefenamic acid, an anti-inflammatory drug, exhibits poor water solubility and flow properties. Spherical agglomerates were prepared by neutralization method. Crystallization medium used for spherical agglomerates of Mefenamic acid consisted of 1 M Sodium hydroxide; 0.7 M hydrochloric acid; iso propyl acetate (bridging liquid) in the ratio of 20:280:15, respectively. Spherical agglomerates were characterized by differential scanning calorimetry, Infrared spectroscopy, X-ray diffractometry and scanning electron microscopy. Micromeritic and dissolution behavior studies were carried out. Process variables such as amount of bridging liquid, stirring time and duration of stirring were optimized. Dissolution profile of the spherical agglomerates was compared with pure sample and recrystallized sample. Spherical agglomerates exhibited decreased crystallinity and improved micromeritic properties. The dissolution of the spherical agglomerates was improved compared with pure sample.