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

Authors :
Grande-Ortiz M
Taipe-Cadenillas S
Villodas-Saldaña C
Rodríguez-Calzado J
Moreno-Exebio L
Source :
Revista peruana de medicina experimental y salud publica [Rev Peru Med Exp Salud Publica] 2019 Jan-Mar; Vol. 36 (1), pp. 74-80. Date of Electronic Publication: 2019 May 13.
Publication Year :
2019

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.

Details

Language :
Spanish; Castilian
ISSN :
1726-4642
Volume :
36
Issue :
1
Database :
MEDLINE
Journal :
Revista peruana de medicina experimental y salud publica
Publication Type :
Academic Journal
Accession number :
31116343
Full Text :
https://doi.org/10.17843/rpmesp.2019.361.3912