Matrix sustained release tablet of water soluble prokinetic agent: Itopride Hydrochloride

Abstract

Itopride hydrochloride is highly water soluble prokinetic drug that is used in the Gastro esophageal reflux disease (GERD). Aim of present investigation was formulating sustained release formulation of Itopride hydrochloride for oral drug delivery. Oral route gets the highest priority for the delivery of the drug as well as better patient compliance in case of self medication. Pregelatinized Starch, Hydroxy methyl propyl cellulose (HPMC) K4M, HPMC K100M and Ethyl Cellulose were used to control the release of the drug from the sustained release tablet. Optimization of polymers concentration that can control the release of the drug as like the hypothetical release profile was based on trial and error. Optimized batch F11 was showing good tablet properties like hardness (7-8kg/cm2), thickness (4.61mm), friability (0.061%), assay (99.3%) and nearly similar drug release profile to the hypothetical drug release profile and it was indicated by similarity factor (F2=80.25). Mathematical model application was applied to the release profile of optimized batch. The obtained value of regression coefficient was 0.9962 which indicate that formulation was following the higuchi model