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Updated: Jun 13, 2026

Large Scale Non-targeted Metabolomic Profiling of Serum by Ultra Performance Liquid Chromatography-Mass Spectrometry (UPLC-MS)
Published on: March 14, 2013
Relative bioavailability study with two oral formulations of topiramate using a validated UPLC-MS/MS method.
I Saavedra1, E Tamayo, A Gamboa
1Laboratory of Pharmacokinetics and Bioavailability, IFT, Molecular and Clinical Pharmacology Program, Biomedical Sciences Institute, Faculty of Medicine, University of Chile, Santiago, Chile.
This study found that Toprel 100 mg is bioequivalent to Topamax 100 mg, meaning the generic anticonvulsant drug is interchangeable with the reference medication. This ensures consistent seizure control for patients.
Area of Science:
- Pharmacokinetics
- Pharmaceutical Sciences
- Clinical Pharmacology
Background:
- Bioavailability changes in anticonvulsant drugs like topiramate can impact seizure control.
- Evaluating bioequivalence between generic and reference formulations is crucial for therapeutic consistency.
Purpose of the Study:
- To assess the bioavailability of two oral topiramate formulations (Toprel and Topamax) in healthy volunteers.
- To determine if the generic formulation (Toprel) is bioequivalent to the reference (Topamax).
Main Methods:
- A double-blind, randomized, crossover study involving 20 healthy volunteers.
- Single oral dose administration of 100 mg topiramate from each formulation after a 12-hour fast.
- Plasma concentrations measured using UPLC-MS/MS, with pharmacokinetic parameters (AUC, Cmax, tmax) analyzed.
Main Results:
- Pharmacokinetic parameters (AUC(0-inf), AUC0-24, tmax, Cmax) showed no statistically significant differences between Toprel and Topamax.
- Key parameters (Cmax, AUC(0-24), AUC(0-inf)) fell within the 0.8-1.25 FDA-recommended range for bioequivalence.
- A 100% probability of bioequivalence was demonstrated between the two formulations.
Conclusions:
- Toprel 100 mg is bioequivalent and interchangeable with Topamax 100 mg.
- The generic formulation ensures comparable therapeutic outcomes to the reference drug.
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