%0 Journal Article
%T Desarrollo de una formulaci車n de tabletas revestidas de secnidazol 500 mg Development of a formulation of coated secnidazole tablets 500 mg
%A Iverlis D赤az Polanco
%A Sa迆l Padr車n Yaquis
%A L車pez Bertha
%A Loreta Delgado
%J Revista Cubana de Farmacia
%D 2008
%I ECIMED
%X Se describe el desarrollo de una formulaci車n de tabletas revestidas de secnidazol 500 mg. Durante el desarrollo de esta se evaluaron 2 m谷todos: la granulaci車n seca y la granulaci車n h迆meda. En el revestimiento de las tabletas se emple車 un sistema hidroalcoh車lico con el preparado comercial Policoat YS 1-7003 (Opadry) . Los lotes sometidos a ensayos de estabilidad fueron elaborados a escala piloto, por la v赤a de granulaci車n h迆meda, lo que demostr車 la factibilidad del proceso de fabricaci車n a esta escala. Las tabletas revestidas presentaron adecuadas propiedades f赤sico-mec芍nicas y tecnol車gicas y estas fueron envasadas en frascos de polietileno de alta densidad y en sobres termoconformados de polivinilcloruro/aluminio. La estabilidad qu赤mica y microbiol車gica de las tabletas de secnidazol fue estudiada durante 24 meses; los resultados demostraron que estas cumpl赤an con los requisitos establecidos durante este periodo The development of a formulation of coated Secnidazole tablets 500mg was described. During its development, 2 methods were evaluated: dry granulation and humid granulation. A hydroalcoholic system was used with the Policoat YS 1-7003 (Opadry)  commercial preparation for coating the tablets. The batches subjected to stability assays were made at pilot scale by humid granulation, which showed the feasibility of the manufacturing process at this scale. The coated tablets had adequate physicomechanical and technological properties and they were packed in polyethylene flasks of high density and in polyvinyl chloride/aluminium thermoconformed envelopes. The chemical and microbiological stability of the secnidazole tablets were studied during 24 months. The results demonstrated that these tablets met the requirements established during this period
%K Secnidazol
%K tabletas revestidas
%K Secnidazole
%K coated tablets
%U http://scielo.sld.cu/scielo.php?script=sci_arttext&pid=S0034-75152008000100004