Controle de qualidade de dipirona solução oral comercializada na cidade de Cuité - PB: avaliação físico-química entre medicamentos de referência, genérico e similares.

Abstract

Dipyrone pyrazolonic is a derivative that has admittedly analgesic and antipyretic actions. In the United States and some countries in europe its use was restricted or prohibited to be associated with toxicities related to blood dyscrasias. In Brazil, its use occurs abusive and indiscriminate, being found in the market under various trade names as the only drugs or associations. The quality of a product is an attribute of character not only commercial, but also legal and moral. For the field of health, non-compliance with requirements considered important in quality control can have serious consequences such as, lack of efficacy in the treatment due to sub-therapeutic dosing and toxicity by super therapeutic doses. Knowing that dipyrone is a drug widely used in Brazil, the aim of this study was to evaluate the physical and chemical quality of five different brands of dipyrone 500 mg oral solution, designated A (reference product), B (generic), C, D and E (similars). We evaluated the following physicochemical parameters: average volume, pH, drip and assay. All tests were performed according to the Brazilian Pharmacopoeia V. As the test medium volume, the generic drug failed because one of its samples gave a value less than 95% of the volume reported by the company. At pH test all samples of all drugs were within the range between 5.5 and 7.0. In the dripping test the drug C flunked because samples possessed content drug per drop lower than 85% of the stated amount. Turn on assay all samples were within the limits recommended by the Pharmacopoeia.