COMPARATIVE DISSOLUTION STUDIES OF WARFARIN SODIUM TABLETS: INFLUENCE OF AGITATION RATE, DISSOLUTION MEDIUM, AND USP APPARATUS

  • José Raúl Medina-López Departamento Sistemas Biologicos, Universidad Autonoma Metropolitana-Xochimilco, Mexico City http://orcid.org/0000-0002-4159-8403
  • Luis Daniel Mazón-Román Departamento Sistemas Biologicos. Universidad Autonoma Metropolitana-Xochimilco, Mexico City, Mexico
  • Juan Manuel Contreras-Jiménez Departamento Sistemas Biologicos. Universidad Autonoma Metropolitana-Xochimilco, Mexico City, Mexico
  • Juan Carlos Ruiz-Segura Departamento Sistemas Biologicos. Universidad Autonoma Metropolitana-Xochimilco, Mexico City, Mexico

Abstract

Objective: The aim of this study was to carry out comparative dissolution studies with warfarin sodium reference tablets under the hydrodynamic environments generated by the USP basket, paddle, and flow-through cell using different agitation rates and dissolution media.


Methods: Dissolution profiles were obtained with the USP basket and paddle apparatuses at 50, 75, and 100 rpm and 900 ml of water as dissolution medium. After this, dissolution profiles of warfarin sodium were obtained with the USP paddle apparatus and flow-through cell method using 0.1 N hydrochloric acid, acetate buffer pH 4.5, phosphate buffer pH 6.8, and water. Spectrophotometric determination at 308 nm was carried out during 30 min. Dissolution profiles were compared with model-independent and -dependent approaches.


Results: Significant differences were found with mean dissolution time and dissolution efficiency at 50 and 75 rpm (*P < 0.05). Makoid-Banakar was the best-fit model used to describe the in vitro release performance of warfarin sodium with 50-100 rpm and the USP basket and paddle apparatuses. Significant differences in all calculated parameters were found (*P < 0.05) excepting percentage dissolved at 30 min with 0.1 N hydrochloric acid and phosphate buffer pH 6.8.


Conclusion: More research is necessary to identify the in vitro release performance of poorly soluble drugs under available USP apparatuses considering factors as agitation rate and kind of dissolution media. The knowledge of the in vitro release performance of references is important for design better generic formulations.

Keywords: Flow-through cell method, reference tablets, USP basket and paddle apparatuses, warfarin sodium

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Medina-López, J. R., Mazón-Román, L. D., Contreras-Jiménez, J. M., & Ruiz-Segura, J. C. (2020). COMPARATIVE DISSOLUTION STUDIES OF WARFARIN SODIUM TABLETS: INFLUENCE OF AGITATION RATE, DISSOLUTION MEDIUM, AND USP APPARATUS. International Journal of Applied Pharmaceutics, 13(1). Retrieved from https://innovareacademics.in/journals/index.php/ijap/article/view/39842
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