IN VITRO EQUIVALENCE STUDY OF GENERIC NAPROXEN SODIUM TABLETS USING THE USP PADDLE APPARATUS AND THE FLOW-THROUGH CELL METHOD
Journal Title: International Journal of Pharmacy and Pharmaceutical Sciences - Year 2015, Vol 7, Issue 7
Abstract
Objective: To perform an in vitro equivalence study of naproxen sodium from six immediate release oral dosage forms under the hydrodynamic environments generated by the flow-through cell method and the USP paddle apparatus.Methods: Dissolution method was properly validated according to standard criteria. Dissolution profiles of all formulations were carried out with an automated flow-through cell (laminar flow at 16 ml/min with 22.6 mm cells) and the USP Apparatus 2 (50 rpm). 0.1 M phosphate buffer pH 7.4 at 37.0±0.5 °C was used as the dissolution medium. Spectrophotometric determination of drug at 332 nm was carried out during 45 min. Dissolution profiles were compared with model-dependent and independent approaches.Results: Significant difference with model-independent parameters, mean dissolution time and dissolution efficiency, using both USP apparatuses, were found (*P<0.05). Best fitting of dissolution data was obtained using the sigmoidal model (R2>0.99). Only with the flow-through cell method linear regression between mean dissolution time and t63.2% values was significant (*P<0.05).Conclusion: The study reveals significant differences in dissolution rate and a great variability for all naproxen sodium tablets when the USP paddle apparatus is used. The alternative dissolution test with the flow-through cell method allows obtaining reliable data which facilitates in vitro equivalence respect the reference product dissolution behavior.Â
Authors and Affiliations
JosÉ RaÚl Medina, Araceli Uribe, Marcela Hurtado, Adriana Miriam DomÃnguez-ramÃrez
Keywords
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