Development and in Vitro/In Vivo Evaluation of Itopride Hydrochloride Expanding Tablets

Abstract Purpose Gastroretentive drug delivery systems (GRDDS) have attracted interest for enhancement of absorption and bioavailability some drugs. Itopride hydrochloride (ITOP) is a used treatment gastroesophageal reflux other gastric motility disorders, but characterized by narrow window short in vivo half-life. Therefore, it expected that its formulation expanding gastroretentive tablets would increase residence, thus leading to decreased frequency administration increased patient compliance. Methods The direct compression method was tablets. Four different hydrophilic polymers (xanthan gum, sodium alginate, gellan pectin) were screened separately with Avicel 102 PVP k30 as excipients. effect factors (polymer type amount, excipient amount) on the tablet properties such hardness, friability, thickness, diameter, weight variation, swelling, vitro dissolution studied. In addition, swelling test, accelerated stability study performed optimized formulation. Results Tablets prepared using xanthan gum exhibited favorable compared gums, however increasing polymer amount led friability. selected obvious expansion reaching 17.45 mm lasting 24 h, coupled sustained release behavior. X-ray scans human volunteers suggested residence stomach period 6 h fed state. Conclusion Successful preparation directly compressible ITOP achieved this study, which result better therapeutic outcome reflux.