The dissolution profile for solid pharmaceutical forms containing chloramphenicol 250 mg available in Brazil was determined using a method from the American Pharmacopoeia (United States Pharmacopoeia, 2004)
Até o início da década de 60, era comum que se considerasse um medicamento eficaz clinicamente apenas assegurando-se o controle de qualidade, que incluía somente o conhecimento das propriedades físicas e físico-químicas do fármaco. A ineficácia clínica e, em alguns casos, intoxicações graves, serviram de alerta para estudos mais profundos sobre os componentes da formulação, processos empregados e características físico-químicas dos fármacos 17 . Dentre as formas farmacêuticas de uso oral, as formas farmacêuticas sólidas -particularmente os comprimidos -têm merecido destaque pela possibilidade de apresentarem problemas de biodisponibilidade.Para obtenção do efeito terapêutico a partir de um medicamento na forma de comprimido, quando administrado por via oral, é necessário que o fármaco passe da forma de dosificação em que se encontra para outra em que seja diretamente absorvível.
ABSTRACTThe clinical inefficacy of many medications has served to highlight the need for deeper studies on the formulation components, processes used and physicochemical characteristics of drugs. The objective of this study was to evaluate the in vitro release of primaquine phosphate from tablets available in Brazil for treating malaria, and the development of new formulations for conventional release. Although the primaquine phosphate tablets studied had been approved according to the criteria proposed by the United States Pharmacopoeia (2006) for the dissolution test, they did not present adequate dissolution performance characteristics, in that there was drug retention during the release process. The results indicate the existence of problems in the primaquine phosphate tablets analyzed, and it may suggest that this is one of the factors responsible for the appearance of parasite resistance.
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