FORMULATION AND EVALUATION OF ENTERIC COATED TABLETS PANTOPRAZOLE SODIUM BY DIRECT COMPRESSION METHOD

Pantoprazole is a proton pump inhibitor, belongs to group of benzimidazole, Pantoprazole sodium were prepared by direct compression method using different concentration of, microcrystalline cellulose as filler, mannitol and dicalcium phosphate as diluents, crosscarmellose sodium as disintegrating agents, magnesium stearate and talc was used as a glidant and lubricant respectively. Direct compression is economic compare to wet granulation since it requires fewer unit operations. This means less equipment, lower power consumption, less space, less time and less labour leading to reduced production cost of tablets. The prepared tablets were evaluated for hardness, weight variation, friability and drug content uniformity and it was found that the results comply with official standards. The prepared tablets were coated using enteric coating polymer such as cellulose acetate phthalate, Eudragit L100 and by dip coating method. The in vitro release was studied using acidic buffer pH 1.2 and phosphate buffer pH 6.8. Prepared all batch’s C2F9 was found best, with hardness 5.60 ± 0.24 (Kg/cm2), drug content 99.08 ± 0.35(%), disintegration time 7.02± 0.21(min), and percentage cumulative drug released which started after 120 min and reached 99.72 after 180 min. Stability studies indicated that the developed tablets were stable and retained their pharmaceutical properties at room temperature and 40 °C / 75% RH for a period of 3 month.

Key words: Pantoprazole, Direct compression, Proton pump inhibitor, Cellulose acetate phthalate, Eudragit L100