Therapeutic equivalence evaluated by in vitro studies of multisource pharmaceutical products: case studies of amoxicillin, doxycycline and fluconazole in Lima, Peru

Authors

  • Miguel Grande-Ortiz Centro Nacional de Control de Calidad, Instituto Nacional de Salud. Lima, Perú. Químico farmacéutico
  • Sandra Taipe-Cadenillas Universidad Privada Norbert Wiener. Lima, Perú. bachiller en Farmacia y Bioquímica
  • Cinthia Villodas-Saldaña Universidad Privada Norbert Wiener. Lima, Perú. bachiller en Farmacia y Bioquímica
  • Javier Rodríguez-Calzado Centro Nacional de Control de Calidad, Instituto Nacional de Salud. Lima, Perú. biólogo
  • Luis Moreno-Exebio Centro Nacional de Control de Calidad, Instituto Nacional de Salud. Lima, Perú. doctor en Farmacia y Bioquímica

DOI:

https://doi.org/10.17843/rpmesp.2019.361.3912

Keywords:

Therapeutic Equivalence, Generic drugs, Biopharmaceutical, Bioequivalent drugs, Dissolution

Abstract

The objective of the study was to determine the therapeutic equivalence evaluated through in vitro studies of four brands of drugs containing amoxicillin, doxycycline, and fluconazole purchased at pharmaceutical facilities in Metropolitan Lima, and to establish their interchangeability with a reference product (RP). A validated method of visible ultraviolet spectrophotometry was used to determine the dissolution profile. The similarity factor (f2) was used to establish the therapeutic equivalence, being considered equivalent if the values of f2 were between 50 and 100. For doxycycline, the four drugs were equivalent in vitro to the RP; for amoxicillin, only two drugs were equivalent in vitro to the RP; and for fluconazole, none was equivalent in vitro to the RP. It is concluded that some amoxicillin and fluconazole drugs circulating in the national market do not meet the therapeutic equivalence assessed by in vitro studies; in other words, they are not interchangeable.

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Published

2019-03-21

Issue

Section

Brief Report

How to Cite

1.
Grande-Ortiz M, Taipe-Cadenillas S, Villodas-Saldaña C, Rodríguez-Calzado J, Moreno-Exebio L. Therapeutic equivalence evaluated by in vitro studies of multisource pharmaceutical products: case studies of amoxicillin, doxycycline and fluconazole in Lima, Peru. Rev Peru Med Exp Salud Publica [Internet]. 2019 Mar. 21 [cited 2024 Apr. 16];36(1):74-80. Available from: https://rpmesp.ins.gob.pe/index.php/rpmesp/article/view/3912