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Dispersiones sólidas de solubilidad mejorada fabricadas en mezcladores de alto corte: una oportunidad para la industria farmacéutica local mexicana
Solid dispersions with improved solubility manufactured in high shear mixers: an opportunity for the local Mexican pharmaceutical industry
Dispersões sólidas com solubilidade melhorada fabricadas em misturadores de alto cisalhamento: uma oportunidade para a indústria farmacêutica mexicana local
DOI:
https://doi.org/10.15446/rcciquifa.v52n1.102588Palabras clave:
Dispersiones sólidas, granulación por fusión, mezclador de alto corte, solubilidad, tecnología farmacéutica, SCB clase II (es)High shear mixer, melt granulation, pharmaceutic technology, solid dispersions, solubility, class II drugs (en)
Misturador de alto cisalhamento, granulação por fusão, tecnologia farmacêutica, dispersões sólidas, solubilidade, fármacos de classe II (pt)
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Introducción: los fármacos clase II representan un alto porcentaje de las moléculas en fase de investigación biomédica. Este grupo atrajo la investigación en los últimos años, ya que su baja solubilidad acuosa condiciona su absorción in vivo, lo que plantea un reto para la tecnología farmacéutica. El diseño de dispersiones sólidas (SD) es una técnica que ha tenido éxito y se basa en la dispersión del fármaco en un acarreador polimérico, promoviendo el estado amorfo del primero. Uno de los métodos de obtención de SD es el de fusión, que se puede llevar a cabo en equipos sofisticados, pero los mezcladores de alto corte (HSM) también son una alternativa para obtener granulados por fusión. Objetivo: el objetivo de este trabajo es revisar si han sido reportados procesos de granulación por fusión utilizado HSM para la fabricación de SD y analizar las fortalezas, debilidades, oportunidades y amenazas de este equipo en dicho proceso. Método: en una metodología de revisión documental, se preseleccionaron 90 publicaciones de las bases de datos PubMed, ScienceDirect y Google Scholar de los últimos 20 años, de las cuales ocho describen el uso del método de granulación por fusión en HSM. Resultados: como resultados se vio que el 100% de estos casos reportó mayor solubilidad y velocidad de disolución que el fármaco puro. Se concluye que las empresas locales que cuentan con HSM tienen el potencial para poner en marcha procesos de fabricación de SD exitosos en HSM, con la ventaja de no hacer una inversión adicional.
Introduction: class II drugs represent a high percentage of the molecules in the biomedical research phase. This group has attracted research in recent years, since its low aqueous solubility conditions its absorption in vivo, which poses a challenge for pharmaceutical technology. Solid dispersion design (SD) is a technique that has been successful and is based on the dispersion of the drug in a polymeric carrier, promoting the amorphous state of the former. One of the methods of obtaining SD is melting, which can be carried out in sophisticated equipment, but high shear mixers (HSM) are also an alternative to obtain granules by melting. Aim: the objective of this work is to review if melt granulation processes have been reported using HSM for the manufacture of SD and to analyze the strengths, weaknesses, opportunities and threats of this equipment in said process. Method: in a documentary review methodology, 90 publications from the PubMed, ScienceDirect and Google Scholar databases from the last 20 years were pre-selected, of which eight describe the use of the fusion granulation method in HSM. Results: as results, it was seen that 100% of these cases reported higher solubility and dissolution speed than the pure drug. It is concluded that local companies that have HSM have the potential to launch successful SD manufacturing processes in HSM, with the advantage of not making an additional investment.
Introdução: os medicamentos de classe II representam uma alta porcentagem das moléculas na fase de pesquisa biomédica. Esse grupo tem atraído pesquisas nos últimos anos, pois sua baixa solubilidade aquosa condiciona sua absorção in vivo, o que representa um desafio para a tecnologia farmacêutica. O desenho de dispersão sólida (SD) é uma técnica que tem obtido sucesso e se baseia na dispersão do fármaco em um carreador polimérico, promovendo o estado amorfo do primeiro. Um dos métodos de obtenção de DS é a fusão, que pode ser realizada em equipamentos sofisticados, mas misturadores de alto cisalhamento (HSM) também são uma alternativa para obtenção de grânulos por fusão. Objetivo: o objetivo deste trabalho é revisar se foram relatados processos de granulação por fusão usando HSM para a fabricação de SD e analisar os pontos fortes, fracos, oportunidades e ameaças desse equipamento no referido processo. Método: em uma metodologia de revisão documental, foram pré-selecionadas 90 publicações das bases de dados PubMed, ScienceDirect e Google Scholar dos últimos 20 anos, das quais oito descrevem o uso do método de granulação por fusão em HSM. Resultados: como resultados, foi visto que 100% desses casos relataram maior solubilidade e velocidade de dissolução do que o fármaco puro. Conclui-se que as empresas locais que possuem HSM têm potencial para lançar com sucesso processos de fabricação de SD em HSM, com a vantagem de não realizar um investimento adicional.
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