Characterization of Plasma Protein Binding and the Effect of the Vehicle of Docetaxel Formulations

  • Maripaz Márquez Centro de Investigación y de Estudios Avanzados del Instituto Politécnico Nacional (CINVESTAV)
  • Liliana Quintanar Instituto Politécnico Nacional (CINVESTAV)
  • Gilberto Castañeda-Hernández Instituto Politécnico Nacional (CINVESTAV)
Keywords: Docetaxel, alpha-1-acid glycoprotein (AAG), Polysorbate 80, generics, protein binging.

Abstract

In this study we provide evidence of the alpha-1-acid glycoprotein (AAG) binding to Docetaxel as a key assay to evaluate formulations from different manufactures. The comparison of generics to the innovator is an active field in Pharmaceutics. While quality control tests are based on the evaluation of the active drug, our results show protein binding and excipients (Polysorbate 80) also play a critical role. We designed an assay by electronic absorption spectroscopy to evaluate the Docetaxel binding to AAG and the influence of Polysorbate 80. We evaluated Docetaxel generics from India and Latin America, our results show some generics of Docetaxel do not match with the innovator. The assay here developed is a feasible and easy access technique that could be implemented as a quick scan of quality control of Docetaxel generics available worldwide.

Author Biographies

Maripaz Márquez, Centro de Investigación y de Estudios Avanzados del Instituto Politécnico Nacional (CINVESTAV)
  1. Departamento de Farmacología
  2. Departamento de Química
Liliana Quintanar, Instituto Politécnico Nacional (CINVESTAV)
Departamento de Química
Gilberto Castañeda-Hernández, Instituto Politécnico Nacional (CINVESTAV)
Departamento de Farmacología

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Published
01-30-2018