Sustained Release Tablet of Itopride Hydrochloride: Formulation, Development and in Vitro Evaluation Reduce Dosing Frequency by Once a Day Delivery

Itopride, a novel prokinetic agent is unique and different from the available prokinetics because of its dual mode of action and lack of significant drug interaction potential. Itopride is a newly developed prokinetic agent, which enhances gastric motility through both anti-dopaminergic and anti-acetylcholinesterage actions. It is best candidate for Gastro Esophageal Reflux Disease. Itopride 50mg can be given thrice in a day for Treatment of GERD. By developing the sustain release formulation of Itopride hydrochloride, the frequency of drug can be reduce to once only to obtain good therapeutic response. The prepared formulation is usually taken on an empty stomach about an hour before meals. Sustained release tablet of Itopride Hydrochloride was prepared by using combination of HPMC grade as matrix forming material. The influence of amount of Hydroxypropyl Methylcellulose K15M and Hydroxypropyl Methylcellulose K100M on release of Itopride hydrochloride was studied using Central composite design. The optimized Formulation FB7 had given prolonged drug release up to 24 hr. It also had desired drug release kinetics and it was found to be stable after 1 month at accelerated conditions.