Migraine follows circadian rhythm in which
headache is more painful at the awakening time. This needs administration of
dosage form at night time to release drug after lag period when
pain gets worse.
Sumatriptan succinate is a
drug of choice for
migraine.
Sumatriptan succinate has bitter taste, low oral bioavailability, and shorter half-life. Present work deals with application of design of experiment for polyox and
xanthan gum in development of press coated floating pulsatile
tablet. Floating pulsatile concept was applied to increase gastric residence of the
dosage form. Burst release was achieved through immediate release
tablet using
crospovidone as superdisintegrant (10%). Pulse lag time was achieved using swellable
polymer polyox WSR 205 and
xanthan gum. 3(2) experimental design was applied. Optimized formulation was evaluated for physical characteristics and in-vitro and in-vivo study. From results, it can be concluded that optimized batch F8 containing polyox WSR205 (72.72%) and
xanthan gum (27.27%) of total weight of
polymer has shown floating lag time of 55 ± 2 sec,
drug content of 100.35 ± 0.4%, hardness of 6 ± 0.1 Kg/cm(2), and 98.69 ± 2% drug release in pulse manner with lag time of 7 ± 0.1 h. Optimized batch showed prolong gastric residence which was confirmed by in-vivo X-ray study.