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Comparative dissolution study on counterfeit medicines of PDE-5 inhibitors

Counterfeit medicines are a growing problem in both developing and industrialised countries. In general the evaluation of these medicines is limited to the identification and the dosage of the active ingredients. In this study in vitro dissolution tests were conducted on two sets of counterfeit medi...

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Detalles Bibliográficos
Autores principales: Deconinck, E., Andriessens, S., Bothy, J.L., Courselle, P., De Beer, J.O.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Xi'an Jiaotong University 2014
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5761215/
https://www.ncbi.nlm.nih.gov/pubmed/29403888
http://dx.doi.org/10.1016/j.jpha.2014.03.002
Descripción
Sumario:Counterfeit medicines are a growing problem in both developing and industrialised countries. In general the evaluation of these medicines is limited to the identification and the dosage of the active ingredients. In this study in vitro dissolution tests were conducted on two sets of counterfeit medicines containing PDE-5 inhibitors (sildenafil citrate and tadalafil). The dissolution profiles were statistically compared to the ones of the genuine products using the f(2)-method and a comparison at each time point using the Cochran test. The results showed low equivalences between counterfeit and genuine products as well as higher variations around the mean dissolution value at the different time points for the counterfeit products.