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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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Preparation and scale up of extended-release tablets of bromopride BJPS
Ferreira,Guilherme Neves; Silva,Marcos Giovani Rodrigues; Fraga,Aline Guerra Manssour; Silva,Luiz Cláudio Rodrigues Pereira da; Lira,Luiz Marcelo; Rodrigues,Carlos Rangel; Castro,Helena Carla; Sousa,Valéria Pereira de; Cabral,Lucio Mendes.
Reproducibility of the tablet manufacturing process and control of its pharmaceutics properties depends on the optimization of formulation aspects and process parameters. Computer simulation such as Design of Experiments (DOE) can be used to scale up the production of this formulation, in particular for obtaining sustained-release tablets. Bromopride formulations are marketed in the form of extended-release pellets, which makes the product more expensive and difficult to manufacture. The aim of this study was to formulate new bromopride sustained release formulations as tablets, and to develop mathematical models to standardize the scale up of this formulation, controlling weight and hardness of the tablets during manufacture according to the USP 34th...
Tipo: Info:eu-repo/semantics/article Palavras-chave: Bromopride/extended-release tablets/preparation; Design of experiments; Extended-release tablets/scale up obtention; Direct compression; Tablets/kinetics release.
Ano: 2014 URL: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502014000200291
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