Multiparticulate systems have biopharmaceutical advantages when compared to the monolithic systems, once they allow different patterns of drug release and can be used in different treatments. The aim of the present work was to develop a biphasic controlled release delivery system, using propranolol hydrochloride (PROP) that can be used for the treatment of circadian diseases. This system was obtained by the combination of cellulosic polymers hydroxypropyl methylcellulose (HPMC) and ethylcellulose (EC) in a 2² factorial experimental design, which allowed the optimization of the development stage. The pellets produced and used in biphasic formulations were evaluated for physical and chemical characteristics and presented acceptable results. The immediate fraction obtained showed the complete release in 30 min while the others kept the release of the drug for 24 h. This study showed that the combination of beads with different releasing characteristics allowed to obtain different release profiles, which can be modulated according to the pathological needs, especially with regard to circadian diseases that suffer alterations throughout the day.
ABSTRACT. Hypertension is one of the most important mortality risks in the world and is considered the leading cause of deaths associated with cardiovascular disease. In an attempt to improve the treatments and apply them to a large number of disorders, a propranolol hydrochloride (Prop) based medicine it was developed in our laboratory, employing a multiparticulate system which operates in a biphasic manner, one portion of immediate and other of modified release. This study aimed at developing and validating a suitable method to quantify this new version of the drug using UV spectrophotometry, following what is recommended in RE 899/2003. The results showed that the method employed was linear, accurate, precise and robust in the range of 0.8 to 96.0 μg mL -1 , which allows it for routine use in quality control laboratories.Keywords: biphasic release, multiparticulate system, pellets.Desenvolvimento e validação de metodologia analítica para quantificação de cloridrato de propranolol em sistema multiparticulado bifásico por espectrofotometria ultravioleta RESUMO. A hipertensão é um dos mais importantes riscos de mortalidade no mundo, sendo considerada a principal causa de mortes associadas a doenças cardiovasculares. Em uma tentativa de obter tratamentos mais eficazes e aplicados a um grande número de desordens, foi desenvolvido, em nosso laboratório, um medicamento à base de cloridrato de propanolol (Prop), empregando um sistema multiparticulado que agisse de forma bifásica, sendo uma fração de liberação imedita e outra de liberação prolongada. Este trabalho teve como objetivo desenvolver e validar um método direcionado para a quantificação dessa nova versão do medicamento, empregando espectrofotometria UV e seguindo o recomendado na RE 899/2003. O método proposto foi linear, exato, preciso e robusto na faixa de 0,8 a 96 μg mL -1 , o que permite sua utilização na rotina de um laboratório de controle de qualidade.Palavras-chave: liberação bifásica, sistema multiparticulado, péletes.
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