ESTUDO DA INTERCAMBIALIDADE DE MEDICAMENTOS NO BRASIL: DOSEAMENTO DE GENÉRICOS E SIMILARES INTERCAMBIÁVEIS DE CAPTOPRIL

Given the availability of interchangeable generic and similar medications on the market, the objective of this study is to evaluate the interchangeability of generic and similar medications in Brazil, through the measurement of captopril. To this end, a brief analysis and discussion of the legal aspects of drug interchangeability in Brazil is necessary. Captopril content analyzes were carried out in five different brands of generics and similar products (three generics and two similar ones) according to the methodology recommended by the Brazilian Pharmacopoeia (2019). The results of the experiment demonstrate that three of the medicines analyzed (two generics and one similar) met the mass standards, while two others (one generic and one similar) exceeded the permitted limit recommended by the Pharmacopoeia, between 90 and 110%. which imposes the realization that strict controls are necessary to guarantee the quality of medicines and, despite the interchangeability between generic medicines and reference medicines being widely accepted, doubts and inconsistencies remain in legislation and clinical practice, especially in relation to similar interchangeable medicines. Keywords: Generic medicines; similar medicines; interchangeability.

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Publication Details

Journal
Zenodo (CERN European Organization for Nuclear Research)
Published
2025-02-14
DOI
https://doi.org/10.5281/zenodo.14873068
Primary Topic
Pharmaceutical Economics and Policy
Type
article
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article

ESTUDO DA INTERCAMBIALIDADE DE MEDICAMENTOS NO BRASIL: DOSEAMENTO DE GENÉRICOS E SIMILARES INTERCAMBIÁVEIS DE CAPTOPRIL

Zenodo (CERN European Organization for Nuclear Research)
Pharmaceutical Economics and Policy
article

ESTUDO DA INTERCAMBIALIDADE DE MEDICAMENTOS NO BRASIL: DOSEAMENTO DE GENÉRICOS E SIMILARES INTERCAMBIÁVEIS DE CAPTOPRIL

article en

Abstract

Given the availability of interchangeable generic and similar medications on the market, the objective of this study is to evaluate the interchangeability of generic and similar medications in Brazil, through the measurement of captopril. To this end, a brief analysis and discussion of the legal aspects of drug interchangeability in Brazil is necessary. Captopril content analyzes were carried out in five different brands of generics and similar products (three generics and two similar ones) according to the methodology recommended by the Brazilian Pharmacopoeia (2019). The results of the experiment demonstrate that three of the medicines analyzed (two generics and one similar) met the mass standards, while two others (one generic and one similar) exceeded the permitted limit recommended by the Pharmacopoeia, between 90 and 110%. which imposes the realization that strict controls are necessary to guarantee the quality of medicines and, despite the interchangeability between generic medicines and reference medicines being widely accepted, doubts and inconsistencies remain in legislation and clinical practice, especially in relation to similar interchangeable medicines. Keywords: Generic medicines; similar medicines; interchangeability.

Zenodo (CERN European Organization for Nuclear Research)
Universidade Santa Cecília (BR)
Good health and well-being
Openalex Percentile: Top 42%
Pharmaceutical Economics and Policy
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