BIOEQUIVALENCE EVALUATION OF ORALLY DISINTEGRATING STRIPS OF RIZATRIPTAN IN MALE VOLUNTEERS UNDER FASTING CONDITIONS

NIDHI SAPKAL; ANWAR DAUD; MINAL BONDE; MANGESH GAWANDE; NILAMBARI GURAV

doi:10.22159/ijap.2021v13i5.41602

Authors

NIDHI SAPKAL Gurunanak College of Pharmacy, Kamptee Road, Nagpur, Maharashtra, India 440026, Zim Laboratories Limited, Kalmeshwar, Nagpur, Maharashtra, India 441501
ANWAR DAUD Zim Laboratories Limited, Kalmeshwar, Nagpur, Maharashtra, India 441501
MINAL BONDE Zim Laboratories Limited, Kalmeshwar, Nagpur, Maharashtra, India 441501
MANGESH GAWANDE Zim Laboratories Limited, Kalmeshwar, Nagpur, Maharashtra, India 441501
NILAMBARI GURAV P.E.S.’s Rajaram and Tarabai Bandekar College of Pharmacy, Goa, India 403401

DOI:

https://doi.org/10.22159/ijap.2021v13i5.41602

Keywords:

Rizatriptan, Orally Disintegrating Strips, Pharmacokinetics, Bioequivalence

Abstract

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 C_max, AUC_0→t, AUC _0→∞, t_1/2, T_max,and Ke1 were estimated for each subject and each treatment.

Results: Ninety percent confidence intervals (90% CI) calculated for the ratio of AUC_0→t, AUC_0→∞, and C_max 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 AUC_0→t, AUC_0→∞, and C_max 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.

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