Therapeutic equivalence evaluated by in vitro studies of multisource pharmaceutical products: case studies of amoxicillin, doxycycline and fluconazole in Lima, Peru
DOI:
https://doi.org/10.17843/rpmesp.2019.361.3912Keywords:
Therapeutic Equivalence, Generic drugs, Biopharmaceutical, Bioequivalent drugs, DissolutionAbstract
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.Downloads
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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 Dec. 9];36(1):74-80. Available from: https://rpmesp.ins.gob.pe/index.php/rpmesp/article/view/3912