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Warfarin bio-availability. A comparison of 4 products
F O Müller1, J M Steyn, H K Hundt
1Department of Pharmacology, University of the Orange Free State, Bloemfontein.
Summary
Four warfarin tablet formulations were compared for bio-availability. All tested warfarin products demonstrated similar safety and efficacy, suggesting interchangeable use.
Area of Science:
- Pharmacokinetics and Drug Bioavailability
- Clinical Pharmacology
- Pharmaceutical Sciences
Background:
- Warfarin is a critical anticoagulant medication.
- Ensuring bio-equivalence between different warfarin formulations is essential for patient safety and therapeutic efficacy.
- Variations in tablet formulations can potentially impact drug absorption and effectiveness.
Purpose of the Study:
- To compare the bio-availability of four different warfarin tablet formulations.
- To determine if generic warfarin products are bio-equivalent to a reference brand (Marevan).
- To assess the interchangeability of various warfarin formulations.
Main Methods:
- A single-blind, cross-over clinical trial involving twelve healthy adult male volunteers.
- Administration of a single 10 mg oral dose of each warfarin formulation.
- Calculation of 95% confidence intervals for the ratio of means for maximum concentration and area under the plasma concentration-time curve (AUC) relative to the reference product.
Main Results:
- Three test warfarin products showed less than a 20% difference compared to the reference product (Marevan).
- Calculated confidence intervals indicated bio-equivalence between the tested formulations.
- No significant pharmacokinetic differences were observed between the warfarin tablet brands.
Conclusions:
- The four warfarin tablet formulations studied are bio-equivalent.
- These warfarin products can be used interchangeably without compromising patient safety or therapeutic efficacy.
- The findings support the use of generic warfarin as a safe alternative to branded versions.