Title:	Avaliação das falsificações e adulterações de medicamentos e suplementos alimentares com esteroides anabolizantes e cafeína, e desenvolvimento de métodos analíticos
Other Titles:	Evaluation of counterfeiting and adulteration of medicines and dietary supplements with anabolic steroids and caffeine, and development of analytical methods
Authors:	Neves, Diana Brito da Justa
Orientador(es)::	Caldas, Eloísa Dutra
Assunto::	Medicamentos - falsificação Suplementação alimentares Anabolizantes Esteróides anabólicos
Issue Date:	2-Feb-2017
Data de defesa::	7-Oct-2016
Citation:	NEVES, Diana Brito da Justa. Avaliação das falsificações e adulterações de medicamentos e suplementos alimentares com esteroides anabolizantes e cafeína, e desenvolvimento de métodos analíticos. 2016. xii, 163, 104 f., il. Tese (Doutorado em Ciências Farmacêuticas)—Universidade de Brasília, Brasília, 2016.
Abstract:	The counterfeiting and adulteration of pharmaceutical products is a worldwide problem, representing a major potential health risk. As a criminal activity, its incidence is not exactly known, but only estimated by specific studies. The aims of the present study were to identify the main medicines containing anabolic steroids and dietary supplements seized by the Brazilian Federal Police (BFP) and the counterfeiting rates reported on forensic reports; evaluate the sanitary legislation concerning supplements in Brazil, United States and European Union; to develop a method to identify counterfeiting of the medicine Durateston®, using spectrometric data obtained at the infrared region (FT-IR) and chemometric tools; to develop GC-MS analytical methods for the quantitative analysis of anabolic steroids in medicines and supplements and of caffeine in supplements and quantify these compounds in products seized by the BFP. Data from forensic reports issued by the BFP from 2006 to 2011 showed that 31.7% of medicines containing anabolic steroids were counterfeits. Data from forensic reports on supplements issued from 2007 to 2013 indicated that 6.2% of chemically analyzed products were identified as counterfeits. Brazilian legislation concerning supplements was regarded as more restrictive than those at the United States and European Union, however, unlike these countries, Brazil does not have a suitable mechanism for notification and disclosure to the general public of the occurrence of supplement adulteration. The method for Durateston® using FT-IR data and chemometrics showed a 100% success rate to discriminate original and counterfeit samples. The quantitative GC-MS methods for the analysis of anabolic steroids in medicines and dietary supplements, and of caffeine in supplements, include only sample extraction and dilution and were satisfactorily validated. The majority (53%) of 328 medicine samples declaring the presence of anabolic steroids were counterfeit or substandard. Five of the 17 supplement samples analyzed contained undeclared anabolic steroids, two at therapeutic levels. A wide range of caffeine levels was found in the 216 supplement samples analyzed (between 0.5 and 394 mg/capsule), often different from what was stated on the labels. The caffeine daily intake from the consumption of 84.3% of the analyzed products exceeded the safe daily dose (400 mg), considering other caffeine sources from the diet. Results from this study indicate the need for more effective actions from sanitary and police authorities for preventing the presence of counterfeit and substandard products on the Brazilian market and in alerting the population for the potential risks involved from the consumption of these products.
metadata.dc.description.unidade:	Faculdade de Ciências da Saúde (FS) Departamento de Farmácia (FS FAR)
Description:	Tese (doutorado)—Universidade de Brasília, Curso de Ciências Farmacêuticas, Programa de Pós-Graduação em Ciências Farmacêuticas, 2016.
metadata.dc.description.ppg:	Programa de Pós-Graduação em Ciências Farmacêuticas
DOI:	http://dx.doi.org/10.26512/2016.10.T.22399
Appears in Collections:	Teses, dissertações e produtos pós-doutorado

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