Bioavailability enhancement of rizatriptan benzoate by oral disintegrating strip: In vitro and in vivo evaluation

In vitro and in vivo evaluation

S. T. Bhagawati, Ankita D. Chonkar, Swapnil J. Dengale, Sreenivasa M. Reddy, Krishnamurthy Bhat

Research output: Contribution to journalArticle

1 Citation (Scopus)

Abstract

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.

Original languageEnglish
Pages (from-to)462-470
Number of pages9
JournalCurrent Drug Delivery
Volume13
Issue number3
Publication statusPublished - 01-05-2016

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Biological Availability
Tablets
Migraine Disorders
Pharmacokinetics
Polyvinyl Alcohol
Drug Compounding
Methylcellulose
Serotonin Receptors
Patient Compliance
Humidity
Hydroxyl Radical
Area Under Curve
High Pressure Liquid Chromatography
In Vitro Techniques
rizatriptan

All Science Journal Classification (ASJC) codes

  • Medicine(all)
  • Pharmaceutical Science

Cite this

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title = "Bioavailability enhancement of rizatriptan benzoate by oral disintegrating strip: In vitro and in vivo evaluation: In vitro and in vivo evaluation",
abstract = "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.",
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