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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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Antiophidian sera sterility control: topics in perspective BJPS
Santos,Paula Gomes; Santos,Dilvani Oliveira; Seródio,Lilia Ribeiro; Marinho,Rachel de Souza; Rodrigues,Carlos Rangel; Cabral,Lucio Mendes; Pádula,Marcelo de; Sousa,Valéria Pereira de; Castro,Helena Carla.
The aim of this work is to review the most important topics about the antiophidic sera sterility, including obtaining methods, sterilization procedures and clean room control using Vital Brazil Institute (VBI) as an example. Bibliographical research was performed through Medline, Lilacs, PubMed, ISI and the Fundação Oswaldo Cruz - RJ and VBI Libraries, from 1960 to 2009. The antiophidic sera for human use are immunobiologic products produced in Brazil by three national laboratories, including VBI. Due to the parenteral use, these products should be sterile and pyrogen-free, which demands the microbiological control during the whole fabrication process. The sterility and pyrogen tests are important steps to ensure the quality and safety of these...
Tipo: Info:eu-repo/semantics/article Palavras-chave: Microbiologic control; Antiophidic sera; Sterility test; Contaminants.
Ano: 2009 URL: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502009000300004
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Rational use of antioxidants in solid oral pharmaceutical preparations BJPS
Celestino,Maísa Teodoro; Magalhães,Uiaran de Oliveira; Fraga,Aline Guerra Manssour; Carmo,Flávia Almada do; Lione,Viviane; Castro,Helena Carla; Sousa,Valeria Pereira de; Rodrigues,Carlos Rangel; Cabral,Lucio Mendes.
Antioxidants are currently used as efficient excipients that delay or inhibit the oxidation process of molecules. Excipients are often associated with adverse reactions. Stability studies can guide the search for solutions that minimize or delay the processes of degradation. The ability to predict oxidation reactions in different drugs is important. Methods: This study was conducted to assess the rational use of butylated hydroxyanisole (BHA), butylated hydroxytoluene (BHT), sodium metabisulfite (SMB), propyl gallate (PG) and cysteine (CYS) in tablet formulations of simvastatin and ketoconazole. These antioxidants were evaluated according to stability parameters and the relationship between efficiency of the antioxidant and chemical structure of the drugs....
Tipo: Info:eu-repo/semantics/article Palavras-chave: Antioxidants/rational use; Excipients/evaluation; Butylated hydroxyanisole/rational use; Butylated hydroxytoluene/rational use; Sodium metabisulfite/rational use; Propyl gallate/rational use; Cysteine/rational use; Simvastatin/tablets; Simvastatin/evaluation; Ketoconazole/tablets; Ketoconazole/evaluation.
Ano: 2012 URL: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502012000300007
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