Bioavailability Enhancement of Rizatriptan Benzoate by Oral Disintegrating Strip: In vitro and In vivo Evaluation
S. T. Bhagawati,
Ankita D. Chonkar,
Swapnil J. Dengale,
Sreenivasa M. Reddy,
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.
Keywords: Bioavailability, HPLC, Oral disintegrating strips, Rizatriptan benzoate, Stability.
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