BIOEQUIVALENCE EVALUATION OF ORALLY DISINTEGRATING STRIPS OF RIZATRIPTAN IN MALE VOLUNTEERS UNDER FASTING CONDITIONS
Keywords:Rizatriptan, Orally Disintegrating Strips, Pharmacokinetics, Bioequivalence
Objective: A randomized, open-label, balanced, two-treatment, two-period, two-sequence, single-dose, crossover bioequivalence study comparing Rizatriptan 10 mg Orally Disintegrating Strips (ODS, test) with that of established Oral Lyophilisate Rizatriptan 10 mg, Maxalt-MLT® (reference) was conducted in 24 healthy male volunteers under fasting conditions. A single oral dose of 10 mg Rizatriptan was administrated to each volunteer.
Methods: Plasma concentrations of Rizatriptan were determined by a validated LC-MS/MS bioanalytical method. The plasma concentrations of Rizatriptan were considered for statistical analysis and for establishing bioequivalence. Pharmacokinetic analysis was done by using the non-compartmental method. Pharmacokinetic parameters Cmax, AUC0→t, AUC 0→∞, t1/2, Tmax, and Ke1 were estimated for each subject and each treatment.
Results: Ninety percent confidence intervals (90% CI) calculated for the ratio of AUC0→t, AUC0→∞, and Cmax values for the test and reference formulations were 96.91-110.30%, 96.24-109.07%, and 90.37-113.56%, respectively for Rizatriptan. The 90% CIs of AUC0→t, AUC0→∞, and Cmax values were totally within 80-125%.
Conclusion: Based on a statistical analysis of the results, both formulations of Rizatriptan 10 mg, were found to be bioequivalent in terms of rate and extent of absorption under fasting conditions.
Staffa JA, Lipton RB, Stewart WE. The epidemiology of migraine headache. Rev Contemp Pharmacother 1994;5:241-52.
Stewart WF, Shechter A, Rasmussen BK. Migraine prevalence: a review of population-based studies. Neurology 1994;44(Suppl 4):17-23.
Hu XH, Markson LE, Lipton RB. Burden of migraine in the United States: disability and economic costs. Arch Intern Med 1999;159:813-8.
Lipton RB, Stewart WF, Von Korff M. The burden of migraine: a review of cost to society. Pharmacoeconomics 1994;6:215-21.
Solomon GD, Price KL. The burden of migraine: a review of its socio-economic impact. Pharmacoeconomics 1997;11(Suppl 1):1-10.
Clarke CE, MacMillan L, Sondhi S. Economic and social impact of migraine. QJM 1996;89:77-84.
Edmeads J, Findlay H, Tugwell P. Impact of migraine and tension-type headache on life-style, consulting behavior, and medication use: a canadian population survey. Can J Neurol Sci 1993;20:131-7.
Arne May. International Encyclopedia of Public Health: Migraine. 2nd edition: Academic Press; 2008. p. 458-62.
Jhingran P, Cady RK, Rubino J. Improvements in health-related quality of life with sumatriptan treatment for migraine. J Fam Pract 1996;42:36-42.
Paul L McCormack, Rachel H Foster. Rizatriptan: a pharmacoeconomic review of its use in the acute treatment of migraine. Pharmacoeconomics 2005;23:1283-98.
Carl GH Dahlof, Alan M Rapoport, Fred D Sheftell. Rizatriptan in the treatment of migraine. Clin Ther 1999;21:1823-36.
MAXALT–MLT ® orally disintegrating tablets; product label package insert (Merck and Co.). Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020864s013lbl.pdf. [Last accessed on 10 Feb 2021]
Lainez MJA. Rizatriptan in the treatment of migraine. Neuropsychiatr Dis Treat 2006;2:247-59.
Teall J, Tuchman M, Cutler N. Rizatriptan (MAXALT) for the acute treatment of migraine and migraine recurrence: a placebo-controlled, outpatient study. Headache: J Head Face Pain 1998;38:281-7.
Dixit RP, Puthli SP. Oral strip technology: overview and future potential. J Controlled Release 2009;139:94-107.
Hoffmann EM, Breitenbach A, Breitkreutz J. Advances in orodispersible films for drug delivery. Expert Opin Drug Delivery 2011;8:299-316.
Hariharan M, Bogue A. Orally dissolving film strips (ODFS): the final evolution of orally dissolving dosage forms. Drug Delivery Technol 2009;9:24-9.
Dahiya M, Saha S, Shahiwala AF. A review on mouth dissolving films. Curr Drug Delivery 2009;6:469-76.
Velusamy S, Masimukkub VM, Chereddy S. Bioanalytical method development and validation of rizatriptan in human plasma using LC-MS/MS method. Int J Chem Anal Sci 2013;4:108-14.
Kulkarni S, Lodhe V. Review on: alternatives to large dosage forms for ease of swallowing. J Drug Delivery Sci Technol 2020;57:1-9.
Irfan M, Rabel S, Bukhtar Q. Orally disintegrating films: a modern expansion in drug delivery system. Saudi Pharm J 2016;10:537-46.
Choksi A, Vaishya R, Inavolu R, Potta T. Intranasal spray formulation containing rizatriptan benzoate for the treatment of migraine. Int J Pharm 2019;571:118702.
K Pallavi, T Pallavi. Formulation and evaluation of fast dissolving films of eletriptan hydrobromide. Int J Curr Pharm Res 2017;9:59-63.
Tiwari RR, Umashankar MS, Damodharan N. Recent update on oral films: a bench to market potential. Int J Appl Pharma 2018;10:27-33.
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