Naratriptan hydrochloride, a bitter-tasting drug was formulated as fast-dissolving, palatable oral films
to mitigate migraine and provide quick relief to migraineurs. Fast dissolving oral films were prepared
by solvent casting method and optimized by applying Box-Behnken design. HPMC E15, stevia extract
powder, and strawberry flavour were selected as independent variables whereas tensile strength,
percent elongation, surface pH, and film thickness served as response parameters respectively. The
prepared films were evaluated for appearance, tensile strength, percent elongation, folding endurance,
thickness, disintegration time, surface pH, and in vitro drug release profile. A double-blind cross-overstudy in human volunteers was used to assess the extent of taste masking and bitterness index of the
optimized formulation. The optimized film had a smooth, elegant, and translucent surface with good
mechanical properties as indicated by tensile strength 0.6125 kg cm-2, percent elongation 29.22%,
surface pH 3.73, and thickness 0.124mm respectively. 100 % in vitro release was achieved within 20
min; the Higuchi model being indicated as a diffusion-controlled release mechanism. Quick in
vivo disintegration was achieved in 17.5 sec. Taste masking and in vivo bitterness evaluation study
indicated that the optimized formulation had a slight but tolerable bitter taste. Thus palatable, fast
dissolving oral films of naratriptan hydrochloride is a potential pharmaceutical approach to alleviate
migraine and provide quick relief from excruciating pain.
Keywords: Box-Behnken design, Fast dissolving oral film, Migraine, Naratriptan hydrochloride,
Solvent casting method, Taste masking
Publication date: 01/07/2022
https://ijbpas.com/pdf/2022/July/MS_IJBPAS_2022_6241.pdf
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https://doi.org/10.31032/IJBPAS/2022/11.7.6241
