Abstract
Oral route gets the highest priority for the delivery of the drug as well as better patient compliance in case of self delivery dosage formulation. The aim of present investigation was undertaken with the objective of formulating sustain release formulation of Itopride hydrochloride for oral drug de livery. Itopride hydrochloride is highly water soluble prokinetic drug . Hydroxypropylmethylcellulose K4M ( lower viscosity grade) and K100M ( higher viscosity grade) were used as a matrix forming agents to control the release of drug. HPMC K4M and HPMC K100M were used individually as well as in combination with different proportion in the preparation of the Sustained release formulation. 3 2 factorial designs were applied to the polymer concentration that affects the drug release profile . Reduced eq uation for drug release at 2hr,6hr, and10hr were
Q2 = 37.644 - 5.41X1 - 3.25X2 - 2.017X12,
Q6 = 72.367 - 8.05X1 - 4.4X2 - 3.75X12, and
Q10 = 90.844 - 5.8X1 - 2.633X2 - 2.8X1X2
respectively. O ptimized batch F019 shows good tablet properties like hardness( 7 - 9kg/cm 2 ), thickness( 4.48 mm ), friability( 0.024% ),assay( 99.3% ) and nea rly similar drug release profile to the ta rgeted reference drug release profile and it was indicated by similarity factor (f2 = 86.04 ).
