Volume 4

October-September 2012

Design and development of floating gastro retentive tablets for mosapride citrate dihydrate: In vitro-in vivo evaluation

Ige Pradum Pundlikrao, Patel Kalpesh Mohanbhai

Abstract:
The aim of the current work is to develop stable formulation of mosapride citrate dihydrate in the form of floating matrix tablet, in combination with two different polymers hydroxy propyl methyl cellulose (HPMC K4M) and Eudragit RS. The Mosapride citrate dihydrate in a form of gastro retentive floating sustained release dosage forms, which provides enhanced bioavailability. In the present study mosapride citrate dihydrate controlled release tablet were prepared with the help of the direct compression method, using sodium bicarbonate and citric acid as the gas forming agent. It was characterized by FTIR spectroscopy, floating ability, swelling ability, in vitro drug release, in vivo x-ray imaging and stability studies. The physical characterization of the floating matrix tablets was examined by SEM and results showed that the shape and texture of the tablets were uniform. Percent drug content from the tablets was determined by UV spectrophotometer and exhibited about 99.32 ± 0.08. The in vitro drug release from the tablets was found to have 78.3 ± 0.2 to 99.04 ± 0.12 for 12 h. The optimized formulations F3 were kept for 90 days at 40°C / 75% RH. After 90 days of exposure the percent drug content was found to be 99.70 ± 0.04. In conclusion, the combination of eudragit RS and HPMC K4M at the 1.0:4.5 w/w ratios could be the effective carrier for the sustained release floating matrix tablets of mosapride citrate dihydrate.

Keywords: Mosapride Citrate Dihydrate, Floating Matrix Tablets, HPMC K4M, Eudragit RS, Gas Forming Agent.