Preparation and characterization of spherical agglomerates of piroxicam by neutralization method

Abstract

Piroxicam, an anti-inflammatory drug, exhibits poor water solubility and flow properties. The aim of the present study was to develop piroxicam spherical agglomerate and was prepared by neutralization method. Crystallization medium used for spherical agglomerates of piroxicam consisted of 1 N sodium hydroxide; 0.07M HC1, chloroform (bridging liquid) in the ratio of 25:67:8 mL, respectively. Spherical agglomerates were characterized by differential scanning calorimetry, Infrared spectroscopy, X-ray diffractometry and scanning electron microscopy. Micromeritic and mechanical property 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. The samples were stored in stability chamber to investigate their physical stability. Spherical agglomerates exhibited decreased crystallinity and improved micromeritic properties then pure piroxicam. The dissolution of the spherical agglomerates was improved compared with pure sample and recrystallized sample. Dissolution of spherical agglomerates showed higher %release i.e., 63.32% in 60 min compare to other pure piroxicam i.e. 38.17%. In stability test, the release profile of the spherical aggolomeration was almost unchanged as compared with the freshly prepared spherical agglomeration stored at 20°C and 45% relative humidity for 90 days. Hence this technique can be used for formulation of tablets of piroxicam by direct compression with directly compressible tablet excipients. © 2011 Academic Journals Inc.