SUSTAINED RELEASE ITOPRIDE HYDROCHLORIDE MATRIX TABLET
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 delivery. 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. 32 factorial designs
were applied to the polymer concentration that affects the
drug release profile. Reduced equation for drug release at
2 1 2 1 Q 37.644 5.41X 3.25X 2.017X ,
6 1 2 1 Q 72.367 8.05X 4.4X 3.75X ,and
10 1 1 2 90.844 5.8 2.633 2.8 2 Q X X X X
respectively. Optimized batch F019 shows good tablet
properties like hardness(7-9kg/cm2), thickness(4.48mm),
friability(0.024%),assay(99.3%) and nearly similar drug
release profile to the targeted reference drug release profile
and it was indicated by similarity factor (f2=86.04).
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