چکیده (انگلیسی):

The aim of this study was to prepare bi-layer tablet of Metoclopramide Hydrochloride (MTH)
and Ibuprofen (IB) for the effective treatment of migraine. MTH and IB were formulated as immediate
and sustained release layer respectively. MTH was formulated as immediate release layer by using
various disintegrants like Ac-Di-Sol, Polyplasdone XL, Explotab, Agar and Gellan Gum. Treated form of
gellan gum and agar was prepared and compared for their disintegrant efficiency with other disintegrants.
IB was formulated as sustained release layer using hydrophilic matrix (hydroxypropylmethylcellulose
[HPMC K4M]). The effect of concentration of hydrophilic matrix (HPMC K4M), binder (polyvinylpyrollidone
[PVP K30]) and buffer (sodium bicarbonate) on IB release was studied. The dissolution study of
sustained release layer showed that an increasing amount of HPMC or PVP K30 results in reduced IB
release. The inclusion of buffer (sodium bicarbonate) enhanced the release of IB from sustained release
layer. The rational for formulation of bi-layer tablet of these two drugs in combination was (1) MTH
increases the absorption of acidic non-steroidal anti-inflammatory drug (NSAID) by increasing gastric
motility. So sequential release of MTH (as immediate release) and IB (as sustained release) was suitable
for treatment of migraine. (2) MTH was degraded when prolonged contact with acidic NSAID. Bi-layer
tablet was suitable for preventing direct contact of these two drugs and thus to maximize the efficacy of
combination of two drugs for migraine.