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Assessment of analytical techniques for characterization of crystalline clopidogrel forms in patent applications BJPS
Lira,Luiz Marcelo; Lourenço,Alexandre Lopes; Neves,Guilherme Ferreira; Sousa,Valéria Pereira de; Rodrigues,Carlos Rangel; Cabral,Lúcio Mendes.
The aim of this study was to evaluate two important aspects of patent applications of crystalline forms of drugs: (i) the physicochemical characterization of the crystalline forms; and (ii) the procedure for preparing crystals of the blockbuster drug clopidogrel. To this end, searches were conducted using online patent databases. The results showed that: (i) the majority of patent applications for clopidogrel crystalline forms failed to comply with proposed Brazilian Patent Office guidelines. This was primarily due to insufficient number of analytical techniques evaluating the crystalline phase. In addition, some patent applications lacked assessment of chemical/crystallography purity; (ii) use of more than two analytical techniques is important; and (iii)...
Tipo: Info:eu-repo/semantics/article Palavras-chave: Clopidogrel/crystalline forms/physicochemical characterization; Clopidogrel/crystalline forms/patents; Polymorphism.
Ano: 2014 URL: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502014000200229
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