title: Crystalline forms of nonprotein drugs filed in Brazil from 1995-2005.
abstract: In the present study, we evaluated 457 patent applications filed for crystalline forms of nonprotein drugs during the period 1995-2005 in Brazil. Online searches were conducted using the Instituto Nacional da Propriedade Industrial patent database and the Derwent Innovations Index(®). It was found that no patent applications in this area were filed by Brazilian applicants. It was also noted that only 61% of patent applications included the characterization of three or more crystalline phase techniques. In most applications, no determination of purity was provided for chemical and/or crystalline phases. In a subset of patent applications, those for blockbuster drugs, we found that approximately 90% did not meet Instituto Nacional da Propriedade Industrial acceptance criteria nor the criteria developed in this study. These results reveal that appropriate and thorough characterization of the crystalline forms of drugs is, indeed, lacking in patent applications.
authors.affiliation: Laboratório de Tecnologia Industrial Farmacêutica (LabTIF), Departamento de Medicamentos, Avenida Carlos Chagas Filho, 373, CCS, Bloco Lss, sala 20, Cidade Universitária. CEP: 21941902, Rio de Janeiro, Universidade Federal do Rio de Janeiro (UFRJ), Brazil.
authors.forename: Luiz Marcelo
authors.initials: LM
authors.lastname: Lira
authors.forename: Luiz Cláudio Rodrigues Pereira
authors.initials: LC
authors.lastname: da Silva
authors.forename: Antônio J
authors.initials: AJ
authors.lastname: Ribeiro
authors.forename: Francisco
authors.initials: F
authors.lastname: Veiga
authors.forename: Carlos Rangel
authors.initials: CR
authors.lastname: Rodrigues
authors.forename: Flávia Almada
authors.initials: FA
authors.lastname: do Carmo
authors.forename: Valéria Pereira
authors.initials: VP
authors.lastname: de Sousa
authors.forename: Lúcio Mendes
authors.initials: LM
authors.lastname: Cabral
mesh_terms: D001938:Brazil; D003460:Crystallization; D004345:Drug Industry; D010330:Patents as Topic; D004364:Pharmaceutical Preparations / Q000737:chemistry; D014961:X-Ray Diffraction
chemical_list: D004364:Pharmaceutical Preparations