Design and in-vitro evaluation of extended release matrix tablets of Itopride hydrochloride

By Doddayya Hiremath, Prakash S.Goudanavar, Dipak S. Phalak, Raghavendra Kulkarni and Sarfaraz Md


This work aims at investigating different types and levels of hydrophilic matrix agents from synthetic origin, hydroxypropyl methylcellulose K100M, and from natural origin, gum karaya, in an attempt to formulate extended release matrix tablets of itopride hydrochloride. HPMC and gum karaya were used alone and in combination to know their efficacy in controlling the release rate of a highly water soluble drug itopride hydrochloride. Itopride hydrochloride is the prokinetic agent which improves GI motility by a dual mode of action, dopamine D2 receptor blockade and acetyl cholinesterase inhibitory action. The tablets, prepared by direct compression, were subjected to physical characterization. Physicochemical interactions between the drugs with excipients were determined by using FTIR and DSC which revealed that there is no interaction between drug with excipients. All the precompression and postcompression parameters were found within acceptable limits. From the obtained data it was concluded that, the release rate was strongly influenced by the concentration of the polymers. The formulation F1, F6 and F8 showed the maximum drug release up to 24 h. The mathematical treatment of in vitro drug release data suggest that, selected formulations close to zero order and showed non-Fickian (anomalous) release as all values of release exponent (n) are between 0.5-0.89.


Key Words : Extended release; Itopride hydrochloride; Hydrophilic  polymers, Direct compression; In-vitro release.

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