COMPARATIVE ANALYSIS OF TABLETS, FROM FORMAL AND INFORMAL MARKET, CONTAINING SILDENAFIL CITRATE

Jonathan Parisotto Peterle, Francie Bueno

Abstract


The sildenafil citrate is a selective inhibitor of the enzyme phosphodiesterase type 5 (PDE5 inhibitor), restoring erectile function of the penis. The aim of this study was to make a comparative analysis of visual appearance, average
weight and content uniformity among the drugs available in the formal and informal markets, by spectrophotometry in the visible region of 535 nm. Analyzing the obtained results, the reference, generic and similar
medicines presented primary and secondary packaging, drug label, intact security seal, homogeneous blue tablets and white core, differing only in format. Meanwhile, the medicine acquired in the informal market, just presented the primary packaging, with heterogeneous blue tablets and irregular format. The reference, generic, similar and informal market medicines, presented respectively, average weight values of 316.3 mg ± 0.0069, 318.0 mg
± 0.0053, 348.2 mg ± 0.0044 and 140.1 mg ± 0.0047, following the determinations of the Brazilian Pharmacopoeia. In the uniformity content test, only the reference, generic and similar, with content values respectively of
103.1% ± 0.5297, 103.9% ± 0.6420 and 100.0% ± 0.8028, fulfilled specifications, while the sample of informal market presented content of 63.7% ± 3,530, not fulfilling determinations of Brazilian legislation. Thus, is noted by this study the great health risk to patients when using the dubious origin of drugs.


Keywords


sildenafil citrate; quality control; Public Health



DOI: http://dx.doi.org/10.14450/2318-9312.v28.e4.a2016.pp226-233

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Copyright (c) 2016 Jonathan Parisotto Peterle, Francie Bueno

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Infarma - Ciências Farmacêuticas

ISSN - 2318-9312 (Versão eletrônica)

ISSN - 0104-0219 (Versão impressa)

Conselho Federal de Farmácia - CFF

SHIS QI 15 Lote "L" - Lago Sul - Brasília - DF

CEP: 71635-615 - Fone: (61)3878-8751

e-mail:infarma@cff.org.br

Diretoria

Walter da Silva Jorge João, Presidente do Conselho Federal de Farmácia

Lenira da Silva Costa, Vice-Presidente do Conselho Federal de Farmácia

João Samuel de Morais Meira, Tesoureiro do Conselho Federal de Farmácia

Luiz Gustavo de Freitas Pires, Secretário-Geral do Conselho Federal de Farmácia