Affiliation: Department of Pharmaceutical Quality Assurance, Manipal College of Pharmaceutical Sciences, Manipal- 576104, India.
Oral disintegrating strips containing rizatriptan benzoate, a selective 5-hydroxy tryptamine receptor agonist with anti migraine property, was developed using polyvinyl alcohol, sodium alginate and hydroxyl propyl methylcellulose as the base materials. The analytical and bioanalytical methods were developed and validated using HPLC (PDA and flouroscence detectors). The dissolution study performed on the strips revealed that all the five formulations, release the drug within eight minutes. Under ICH accelerated stability conditions, strips were stable at 40°C and 75% humidity for eight weeks. Furthermore, pharmacokinetic properties of oral strip were compared with rizatriptan benzoate marketed tablet. Oral disintegrating strip and tablet showed significantly higher bioavailability. Oral strip exhibited better pharmacokinetic parameters than rizatriptan marketed tablet. The Tmax, Cmax, AUC and t1/2 for oral strip were found to be 1.00 h, 64.13±19.46 ng/mL, 352.00±71.57 ng/mL/h and 3.09±1.03 h respectively, whereas, tablet showed 1.5 h, 38.00±13.43 ng/mL, 210.38± 40.37ng/mL/h and 1.66±0.31 h respectively. These findings confirm that the rizatriptan benzoate oral disintegrating strip is potentially a useful tool for an effective treatment of migraine with improved bioavailability, rapid onset of action and with increased patient compliance.