ABSTRACT:
The aim of this study was to explore the feasibility of time and pH dependent enteric-coated matrix system for treatment of irritable bowel syndrome and constipation with single daily dose of Tegaserod maleate. Tegaserod maleate enteric coated tablets were prepared by using Eudragit L-100 and Eudragit S-100 polymer for pH dependent and HPMC K4M and HPMC K15M for time dependent. These were then coated with CAP. The in-vitro release behavior was studied. The results showed that no drug was released in 0.1 mol/L hydrochloric acid within 2 h, and about 50% of the drug was released in the pH 6.8 phosphate buffer within 6 h and remaining release was done in pH 7.4 colonic buffer till the completion for 12-15 h. The studies were also carried out rat fecal matter only to study the microbial degradation of drug for the optimized batch. A close correlation existed between the in-vitro release rate of the pH-dependent and time dependent system. The best fit model was found to be zero order for most of the batches. The results of the present study have demonstrated that the pH-dependent and time dependent tablet system is a promising vehicle for preventing and improving oral bioavailability of TM for the treatment of irritable bowel syndrome. From the present study that slow and controlled release of tegaserod maleate over a period of 24 hours was obtained use of hydrophilic polymer like HPMC K4M (10%) and Eudragit L100 (25%).