Do generic pharmaceutical drugs contain more impurities?

• Autor(a) principal: Rodrigues, Cristina Dara Velho
• Data de Publicação: 2019
• Tipo de documento: Dissertação
• Idioma: eng
• Título da fonte: Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
• Texto Completo: http://hdl.handle.net/10773/27812
• topic: Generic drugs; Inductively Coupled Plasma Mass Spectrometry; Pharmaceutical drugs; Elemental Impurities; Method validation

Generic drugs are currently sold all over European union presenting a much more appealing price than their corresponding pharmaceutical drugs from other brands, which frequently influence the consumer regarding the choice of the drug brand. The lower prices are mostly due to the fact that the legislation applied to the generic drugs is currently simplified comparatively to the respective reference pharmaceutical drugs legislation, allowing that the pharmaceutical industry produce generic drugs at a lower cost. In order to reduce production costs even more, are often use different excipients and raw materials that sometimes present lower quality and may contain in their matrix several contaminants considered dangerous. In addition, there are several reported cases of incidents with generic drugs and generic pharmaceutical products with different side effects compared to their reference products, which raises many doubts and lack of trust in this type of pharmaceutical products both by health professionals and users. The aim of this dissertation is the acknowledgement of the studies published about the topic mentioned above, specifically, the determination and quantification of elemental impurities present in pharmaceutical drugs. It is also presented to validate the quantification method of manganese, chromium and cooper in pharmaceutical drugs, as well as, the determination and comparison of elemental impurities in both generic and respective reference pharmaceutical drugs.